Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-04 @ 5:48 AM
Study NCT ID:
NCT00684203
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2008-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530299', 'term': 'vorapaxar'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Prior approval by the Sponsor is required before the results obtained in the clinical study can be made public by the investigator (sub-investigator) in a publication or at a medical meeting.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 121', 'description': 'As this was a safety study of Vorapaxar in a clinical setting administered concomitantly with other antiplatelet agents, safety data were collected for all 120 enrolled participants on study, regardless of treatment with study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Vorapaxar 20 mg/1 mg', 'description': 'Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Vorapaxar 20 mg/2.5 mg', 'description': 'Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).', 'otherNumAtRisk': 24, 'otherNumAffected': 23, 'seriousNumAtRisk': 24, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Vorapaxar 40 mg/1 mg', 'description': 'Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).', 'otherNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Vorapaxar 40 mg/2.5 mg', 'description': 'Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).', 'otherNumAtRisk': 26, 'otherNumAffected': 23, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo/Placebo', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).', 'otherNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal Distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Puncture Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 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{'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Venipuncture Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Post Procedural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 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25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Supraventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ventricle Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sudden Hearing Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Malaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Post Procedural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Colon Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Loss of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arteriosclerosis Obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 60', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg/1 mg PCI', 'description': 'Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 20 mg/2.5 mg PCI', 'description': 'Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Vorapaxar 40 mg/1 mg PCI', 'description': 'Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG003', 'title': 'Vorapaxar 40 mg/2.5 mg PCI', 'description': 'Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG004', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 121', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 1 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 2.5 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Major TIMI Bleeding Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Minor TIMI Bleeding Events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Non-TIMI Bleeding Events', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 60', 'description': 'Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages \\<10 mm evident only on gradient-echo magnetic resonance imaging \\[MRI\\]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to \\<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 1 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 2.5 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 74 (follow-up period)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 90 (follow-up period)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 121 (follow-up period)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 30, Day 60, Day 74, Day 90, Day 121', 'description': 'Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available.'}, {'type': 'SECONDARY', 'title': 'Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 1 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 2.5 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Baseline (n=37, 34, 21)', 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '4.50'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '8.36'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '0.66', 'upperLimit': '4.50'}]}]}, {'title': 'Day 30 (n=35, 34, 21)', 'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '7.90'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '5.62'}, {'value': '2.99', 'groupId': 'OG002', 'lowerLimit': '1.14', 'upperLimit': '9.40'}]}]}, {'title': 'Day 60 (n=30, 25, 13)', 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '3.00'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '2.02'}, {'value': '1.27', 'groupId': 'OG002', 'lowerLimit': '0.61', 'upperLimit': '4.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day 30, Day 60', 'description': 'Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available.'}, {'type': 'SECONDARY', 'title': 'Mean CD40 Ligand Levels Among Participants Who Underwent PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 1 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 2.5 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Baseline (n=37, 34, 21)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '4.50'}, {'value': '6.9', 'spread': '0.60', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '8.36'}, {'value': '4.8', 'spread': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.66', 'upperLimit': '4.50'}]}]}, {'title': 'Day 30 (n=35, 34, 31)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '7.90'}, {'value': '5.9', 'spread': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '5.62'}, {'value': '6.2', 'spread': '0.73', 'groupId': 'OG002', 'lowerLimit': '1.14', 'upperLimit': '9.40'}]}]}, {'title': 'Day 60 (n=30, 25, 13)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '3.00'}, {'value': '5.4', 'spread': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '2.02'}, {'value': '5.7', 'spread': '1.21', 'groupId': 'OG002', 'lowerLimit': '0.61', 'upperLimit': '4.88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Day 60', 'description': 'Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available.'}, {'type': 'SECONDARY', 'title': 'Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 1 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 2.5 mg Maintenance Dose PCI', 'description': 'Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Baseline (n=4, 4, 3)', 'categories': [{'measurements': [{'value': '24.8', 'spread': '2.86', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '4.50'}, {'value': '16.5', 'spread': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '8.36'}, {'value': '15.9', 'spread': '1.25', 'groupId': 'OG002', 'lowerLimit': '0.66', 'upperLimit': '4.50'}]}]}, {'title': 'Day 30 (n=3, 4, 3)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '1.76', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '7.90'}, {'value': '16.4', 'spread': '0.85', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '5.62'}, {'value': '18.8', 'spread': '0.91', 'groupId': 'OG002', 'lowerLimit': '1.14', 'upperLimit': '9.40'}]}]}, {'title': 'Day 60 (n=2, 3, 1)', 'categories': [{'measurements': [{'value': '25.0', 'spread': '2.80', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '3.00'}, {'value': '14.9', 'spread': '0.62', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '2.02'}, {'value': '19.4', 'spread': 'NA', 'comment': 'SE not calculable since n=1.', 'groupId': 'OG002', 'lowerLimit': '0.61', 'upperLimit': '4.88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Day 60', 'description': 'Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.', 'unitOfMeasure': 'Arbitrary Units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg/1 mg PCI', 'description': 'Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 20 mg/2.5 mg PCI', 'description': 'Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Vorapaxar 40 mg/1 mg PCI', 'description': 'Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG003', 'title': 'Vorapaxar 40 mg/2.5 mg PCI', 'description': 'Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG004', 'title': 'Placebo/Placebo PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Treatment Phase', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Post-Hospital Discharge', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 121', 'description': 'Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Major TIMI Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Minor TIMI Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-TIMI Bleeding Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 60', 'description': 'Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages \\<10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to \\<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 121', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'timeFrame': 'Up to 10 Hours Post-CABG', 'description': 'Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 60', 'description': 'Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 30', 'description': 'Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available.'}, {'type': 'SECONDARY', 'title': 'Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.57', 'spread': '5.70', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '6.94', 'spread': '12.01', 'groupId': 'OG002'}]}]}, {'title': 'Time of Hospital Discharge', 'categories': [{'measurements': [{'value': '3.56', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '5.00', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '0.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline Up To Day 60', 'description': 'Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available.'}, {'type': 'SECONDARY', 'title': 'Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '4.06', 'groupId': 'OG002'}]}]}, {'title': 'Time of Hospital Discharge', 'categories': [{'measurements': [{'value': '10.1', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '4.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up To Day 60', 'description': 'Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vorapaxar 20 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG001', 'title': 'Vorapaxar 40 mg Loading Dose Non-PCI', 'description': 'Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'OG002', 'title': 'Placebo/Placebo Non-PCI', 'description': 'Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'classes': [{'title': 'Intracranial hemorrhage', 'categories': [{'measurements': [{'value': '0', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '0', 'spread': '4.06', 'groupId': 'OG002'}]}]}, {'title': 'Bleeding requiring transfusion', 'categories': [{'measurements': [{'value': '1', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '2', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '0', 'spread': '4.64', 'groupId': 'OG002'}]}]}, {'title': 'Bleeding requiring hospitalization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Major TIMI bleeding', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Up To Day 60', 'description': 'Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vorapaxar 20 mg (PCI)', 'description': 'Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'FG001', 'title': 'Vorapaxar 40 mg (PCI)', 'description': 'Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'FG002', 'title': 'Placebo/Placebo (PCI)', 'description': 'Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'FG003', 'title': 'Vorapaxar 20 mg (Non-PCI)', 'description': 'Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).'}, {'id': 'FG004', 'title': 'Vorapaxar 40 mg (Non-PCI)', 'description': 'Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'FG005', 'title': 'Placebo/Placebo (Non-PCI)', 'description': 'Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol-defined clinical event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Did not meet protocol eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 120 participants enrolled and randomized to treatment, 117 participants were treated with study drug. 92 participants underwent percutaneous coronary intervention (PCI) and 25 did not.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '117', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Vorapaxar 20 mg (PCI)', 'description': 'Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'BG001', 'title': 'Vorapaxar 40 mg (PCI)', 'description': 'Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'BG002', 'title': 'Placebo/Placebo (PCI)', 'description': 'Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'BG003', 'title': 'Vorapaxar 20 mg (Non-PCI)', 'description': 'Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).'}, {'id': 'BG004', 'title': 'Vorapaxar 40 mg (Non-PCI)', 'description': 'Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'BG005', 'title': 'Placebo/Placebo (Non-PCI)', 'description': 'Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '59.0', 'spread': '14.3', 'groupId': 'BG003'}, {'value': '64.1', 'spread': '13.6', 'groupId': 'BG004'}, {'value': '66.5', 'spread': '3.5', 'groupId': 'BG005'}, {'value': '64.2', 'spread': '10.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '88', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2008-10-09', 'completionDateStruct': {'date': '2007-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2008-05-22', 'dispFirstSubmitQcDate': '2009-10-21', 'resultsFirstSubmitDate': '2014-05-09', 'studyFirstSubmitQcDate': '2008-05-22', 'dispFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-28', 'studyFirstPostDateStruct': {'date': '2008-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)', 'timeFrame': 'Up to Day 60', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI', 'timeFrame': 'Up to Day 121', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.'}, {'measure': 'Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI', 'timeFrame': 'Up to Day 60', 'description': 'Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages \\<10 mm evident only on gradient-echo magnetic resonance imaging \\[MRI\\]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to \\<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.'}, {'measure': 'Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit', 'timeFrame': 'Baseline, Day 30, Day 60, Day 74, Day 90, Day 121', 'description': 'Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.'}, {'measure': 'Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit', 'timeFrame': 'Baseline, Day 30, Day 60', 'description': 'Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.'}, {'measure': 'Mean CD40 Ligand Levels Among Participants Who Underwent PCI', 'timeFrame': 'Baseline, Day 30, Day 60', 'description': 'Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.'}, {'measure': 'Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI', 'timeFrame': 'Baseline, Day 30, Day 60', 'description': 'Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.'}, {'measure': 'Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge', 'timeFrame': 'Up to Day 121', 'description': 'Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.'}, {'measure': 'Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI', 'timeFrame': 'Up to Day 60', 'description': 'Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages \\<10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to \\<5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.'}, {'measure': 'Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI', 'timeFrame': 'Up to Day 121', 'description': 'An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.'}, {'measure': 'Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events', 'timeFrame': 'Up to 10 Hours Post-CABG', 'description': 'Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.'}, {'measure': 'Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion', 'timeFrame': 'Up to Day 60', 'description': 'Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.'}, {'measure': 'Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization', 'timeFrame': 'Up to Day 30', 'description': 'Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.'}, {'measure': 'Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI', 'timeFrame': 'Baseline Up To Day 60', 'description': 'Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.'}, {'measure': 'Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI', 'timeFrame': 'Baseline Up To Day 60', 'description': 'Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.'}, {'measure': 'Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events', 'timeFrame': 'Baseline Up To Day 60', 'description': 'Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Myocardial Ischemia', 'Myocardial Infarction']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=P04772&kw=P04772&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '20124733', 'type': 'RESULT', 'citation': 'Goto S, Yamaguchi T, Ikeda Y, Kato K, Yamaguchi H, Jensen P. Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. J Atheroscler Thromb. 2010 Feb 26;17(2):156-64. doi: 10.5551/jat.3038. Epub 2010 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.', 'detailedDescription': 'The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged 18 years or more with history of cardiac ischemia related chest discomfort of \\> 10 minutes duration \\< 24 hours prior to randomization, and having at least 1 of the following A or B. Participants who are planned to undergo PCI will be the target participants.\n\n * A: Positive biomarkers \\[Elevated troponin I or creatinine kinase MB isozyme greater than the site's upper limit of normal (ULN)\\] at or before registration\n * B: Electrocardiogram (ECG) changes: ST segment depression \\>= 0.1 mV (\\>=1 mm), or transient (\\<30 minutes) ST segment elevation \\>= 0.1 mV (\\>=1 mm) in at least 2 contiguous leads\n* Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.\n* Women of child-bearing potential (all postmenarchal women who are \\<1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.\n\nExclusion Criteria:\n\n* Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)\n* Any serious illness or any condition that the investigator feels would pose a significant hazard to the participant if investigational therapy were initiated\n* known hypersensitivity to any component of the current investigational product;\n* Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment\n* Member of the staff personnel directly involved with this study;\n* Family member of the investigational study staff;\n* History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment\n* History of a hemorrhagic stroke at any time\n* Severe hypertension (systolic blood pressure \\>200 mm Hg or diastolic blood pressure \\>110 mm Hg) while receiving therapy;\n* Major surgery within 2 weeks prior to enrollment\n* Known platelet count \\<100,000/mm\\^3\n* Uncontrolled cardiac arrhythmia;\n* Known impairment of renal function (serum creatinine \\>2.0 mg/dL \\[\\>176.8 umol/L\\]), dysproteinemia, nephrotic syndrome, or other renal disease;\n* Active or chronic hepatobiliary or hepatic disease, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) activity more than two times greater than the upper limit of the laboratory reference range\n* Anticipated staged PCI\n* Concurrent or anticipated treatment with warfarin, factor Xa inhibitor, direct thrombin inhibitor, or antiplatelet agents except aspirin and ticlopidine after enrollment\n* Anticipated intracoronary brachytherapy"}, 'identificationModule': {'nctId': 'NCT00684203', 'briefTitle': 'Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'P04772'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vorapaxar 20 mg/1 mg', 'description': 'Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)', 'interventionNames': ['Drug: Vorapaxar', 'Drug: Aspirin', 'Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Vorapaxar 20 mg/2.5 mg', 'description': 'Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)', 'interventionNames': ['Drug: Vorapaxar', 'Drug: Aspirin', 'Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Vorapaxar 40 mg/1 mg', 'description': 'Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine)', 'interventionNames': ['Drug: Vorapaxar', 'Drug: Aspirin', 'Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Vorapaxar 40 mg/2.5 mg', 'description': 'Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine)', 'interventionNames': ['Drug: Vorapaxar', 'Drug: Aspirin', 'Drug: Clopidogrel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)', 'interventionNames': ['Drug: Placebo', 'Drug: Aspirin', 'Drug: Clopidogrel']}], 'interventions': [{'name': 'Vorapaxar', 'type': 'DRUG', 'description': 'Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days', 'armGroupLabels': ['Vorapaxar 20 mg/1 mg', 'Vorapaxar 20 mg/2.5 mg', 'Vorapaxar 40 mg/1 mg', 'Vorapaxar 40 mg/2.5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days', 'armGroupLabels': ['Placebo']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['ASA, acetylsalicylic acid'], 'description': 'Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days.', 'armGroupLabels': ['Placebo', 'Vorapaxar 20 mg/1 mg', 'Vorapaxar 20 mg/2.5 mg', 'Vorapaxar 40 mg/1 mg', 'Vorapaxar 40 mg/2.5 mg']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': '100 mg two or three times daily for 60 days.', 'armGroupLabels': ['Placebo', 'Vorapaxar 20 mg/1 mg', 'Vorapaxar 20 mg/2.5 mg', 'Vorapaxar 40 mg/1 mg', 'Vorapaxar 40 mg/2.5 mg']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}