Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT01766466
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2013-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cangrelor Ticagrelor Transition Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117446', 'term': 'cangrelor'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jayne.prats@themedco.com', 'phone': '888.779.MDCO', 'title': 'Jayne Prats, PhD - VP, Global Knowledge Management', 'phoneExt': '1510', 'organization': 'The Medicines Company'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cangrelor + Ticagrelor 90mg (6 Doses)', 'description': 'Ticagrelor was discontinued 24 h prior to cangrelor infusion', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cangrelor + Ticagrelor 90mg (7 Doses)', 'description': 'Ticagrelor discontinued 12 h prior to cangrelor infusion', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients'}, {'id': 'OG001', 'title': 'Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion', 'description': 'Cangrelor was administered as IV infusion for 2 hours.'}, {'id': 'OG002', 'title': 'Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion', 'description': 'Cangrelor was administered as IV infusion for 2 hours.'}], 'classes': [{'title': 'Reference 0.5/1.25 hours - PR', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '2', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': '1.75 hours - PR', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '2.0 hours - PR', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)', 'description': 'A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).', 'unitOfMeasure': 'percentage of platelet reactivity (PR)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients'}, {'id': 'OG001', 'title': 'Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion'}, {'id': 'OG002', 'title': 'Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion'}], 'classes': [{'title': '1.0 hours - PR', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': '2.0 hours - PR', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion', 'description': 'A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.\n\nResidual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).', 'unitOfMeasure': 'percentage of platelet reactivity (PR)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Extent of Aggregation Response During Ticagrelor Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients'}, {'id': 'OG001', 'title': 'Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion', 'description': 'Cangrelor was administered as IV infusion for 2 hours.'}, {'id': 'OG002', 'title': 'Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion', 'description': 'Cangrelor was administered as IV infusion for 2 hours.'}], 'classes': [{'title': 'Reference 5.25 hours - PR', 'categories': [{'measurements': [{'value': '4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': '2.25 hours - PR', 'categories': [{'measurements': [{'value': '12', 'spread': '11', 'groupId': 'OG000'}, {'value': '11', 'spread': '12', 'groupId': 'OG001'}, {'value': '13', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': '2.5 hours - PR', 'categories': [{'measurements': [{'value': '19', 'spread': '16', 'groupId': 'OG000'}, {'value': '21', 'spread': '17', 'groupId': 'OG001'}, {'value': '16', 'spread': '15', 'groupId': 'OG002'}]}]}, {'title': '2.75 hours - PR', 'categories': [{'measurements': [{'value': '10', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '12', 'spread': '11', 'groupId': 'OG002'}]}]}, {'title': '3 hours - PR', 'categories': [{'measurements': [{'value': '7.1', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '10', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': '4 hours - PR', 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion', 'description': 'Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.\n\nA reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.\n\nResidual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).', 'unitOfMeasure': 'percentage of platelet reactivity (PR)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h', 'description': 'Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion.'}, {'id': 'FG001', 'title': 'Day 5 - Ticagrelor (90 mg) Dosing (6 Doses)', 'description': 'Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion.'}, {'id': 'FG002', 'title': 'Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h', 'description': 'Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion.'}, {'id': 'FG003', 'title': 'Day 5 - Ticagrelor (90mg) Dosing (7 Doses)', 'description': 'Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.'}], 'periods': [{'title': 'Day 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Day 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The purpose of this study was to study the pharmacodynamic characteristics of transition from IV cangrelor to oral ticagrelor, and ticagrelor to cangrelor in patients with coronary artery disease. This was a single-center study, conducted in Jan-Feb 2013.', 'preAssignmentDetails': 'Patients with coronary artery disease who were taking aspirin, but not P2Y12 inhibition were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ITT Population - Ticagrelor 6 Doses', 'description': 'On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.\n\nOn Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior.'}, {'id': 'BG001', 'title': 'ITT Population - Ticagrelor 7 Doses', 'description': 'On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.\n\nOn Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '7.17', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '4.32', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '5.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2013-01-07', 'resultsFirstSubmitDate': '2013-04-23', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-18', 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)', 'timeFrame': 'Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)', 'description': 'A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).'}, {'measure': 'Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor', 'timeFrame': 'Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion', 'description': 'A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.\n\nResidual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).'}, {'measure': 'Extent of Aggregation Response During Ticagrelor Treatment', 'timeFrame': 'Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion', 'description': 'Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.\n\nA reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.\n\nResidual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'To demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than / equal to 18 and less than 75 years of age\n\n 1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic q waves on at least 2 contiguous electrocardiogram (ECG) leads.\n\n OR\n 2. Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.\n\n AND\n 3. Treatment with aspirin (ASA) 81 mg daily.\n\n Exclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01766466', 'briefTitle': 'Cangrelor Ticagrelor Transition Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Medicines Company'}, 'officialTitle': 'A Study of the Transition From Cangrelor to Ticagrelor, and Ticagrelor to Cangrelor in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'MDCO-CAN-12-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cangrelor IV + Ticagrelor 180mg at 0.5 hr', 'description': 'On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h after the initiation of cangrelor infusion.', 'interventionNames': ['Drug: cangrelor', 'Drug: Ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'Cangrelor IV + Ticagrelor 90mg (7 doses)', 'description': 'On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses (12, 24, 36, 48, 60, 72, and 84 h).\n\nOn Day 5: 12 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.', 'interventionNames': ['Drug: cangrelor', 'Drug: Ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'Cangrelor IV + Ticagrelor 180mg at 1.5 hr', 'description': 'On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 1.5 h after the initiation of cangrelor infusion.', 'interventionNames': ['Drug: cangrelor', 'Drug: Ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'Cangrelor IV + Ticagrelor 90mg (6 doses)', 'description': 'On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses (12, 24, 36, 48, 60, and 72 h).\n\nOn Day 5: 24 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.', 'interventionNames': ['Drug: cangrelor', 'Drug: Ticagrelor']}], 'interventions': [{'name': 'cangrelor', 'type': 'DRUG', 'description': 'Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.', 'armGroupLabels': ['Cangrelor IV + Ticagrelor 180mg at 0.5 hr', 'Cangrelor IV + Ticagrelor 180mg at 1.5 hr', 'Cangrelor IV + Ticagrelor 90mg (6 doses)', 'Cangrelor IV + Ticagrelor 90mg (7 doses)']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilinta'], 'description': 'Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion\n\nTicagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.', 'armGroupLabels': ['Cangrelor IV + Ticagrelor 180mg at 0.5 hr', 'Cangrelor IV + Ticagrelor 180mg at 1.5 hr', 'Cangrelor IV + Ticagrelor 90mg (6 doses)', 'Cangrelor IV + Ticagrelor 90mg (7 doses)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'David J. Schneider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Medicines Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}