Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 2:13 AM
Study NCT ID:
NCT04409834
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2020-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'covid-pact@bwh.harvard.edu', 'phone': '(617) 278-0145', 'title': 'COVID-PACT Project Manager', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': 'Investigators are required to report: (1) Serious Adverse Events Related to Study Drug, (2) Unexpected Problems, and (3) Adverse Events Leading to Drug Discontinuation.', 'eventGroups': [{'id': 'EG000', 'title': 'Full-dose Anticoagulation (FDAC)', 'description': '* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE\n* Enoxaparin 1 mg/kg administered subcutaneously(SC) every 12 hours\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 37, 'seriousNumAtRisk': 197, 'deathsNumAffected': 55, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Standard-dose Prophylactic Anticoagulation (SDPAC)', 'description': '* Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if CrCl\\<30 ml/min)\n* Heparin 5,000 units administered subcutaneous three times daily\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 22, 'seriousNumAtRisk': 193, 'deathsNumAffected': 62, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Antiplatelet Therapy', 'description': 'Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 25, 'seriousNumAtRisk': 152, 'deathsNumAffected': 41, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'No Anti-platelet Therapy', 'description': 'Participants did not receive anti-platelet therapy.', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 0, 'seriousNumAtRisk': 140, 'deathsNumAffected': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'D-dimer elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Compartment Syndrome Left Arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Induced Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gross Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial Hemmorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower Respiratory Tract Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary bleeding from left upper lobe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectus Sheath Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Rectus Intramuscular Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right upper extremity soft tissue hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right wrist intramural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Full-dose Anticoagulation', 'description': '* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE\n* Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours'}, {'id': 'OG001', 'title': 'Prophylactic Anticoagulation', 'description': '* Enoxaparin 40 mg administered SC once daily (reduce to 30 mg if CrCl\\<30 ml/min)\\*\n* Heparin 5,000 units administered SC three times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4,486', 'groupId': 'OG000'}, {'value': '2,351', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '1.08', 'ciUpperLimit': '3.55', 'groupDescription': 'FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation', 'statisticalMethod': 'Stratified Win-Ratio Analysis, 2-sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Win-Ratio Analysis, 2-sided\n\n* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.\n* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352).'}], 'paramType': 'NUMBER', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the FDAC (Full-dose anticoagulation) arm to every patient in the SDPAC (Standard dose prophylactic anticoagulation) arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT.", 'unitOfMeasure': 'Number of wins', 'reportingStatus': 'POSTED', 'populationDescription': 'The on-treatment analysis population, consisting of all randomly assigned patients who received at least 1 dose of the randomly allocated study strategy. As is pre-specified in the Study Protocol, comparisons between FDAC and SDPAC are reported irrespective of whether participants received anti-platelet therapy.'}, {'type': 'SECONDARY', 'title': 'Clinically Evident Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Full-dose Anticoagulation', 'description': '* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE\n* Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours'}, {'id': 'OG001', 'title': 'Prophylactic Anticoagulation', 'description': '* Enoxaparin 40 mg administered SC once daily (reduce to 30 mg if CrCl\\<30 ml/min)\n* Heparin 5,000 units administered SC three times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3,649', 'groupId': 'OG000'}, {'value': '2,021', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.92', 'ciUpperLimit': '3.47', 'groupDescription': 'FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation', 'statisticalMethod': 'Stratified Win-Ratio Analysis, 2-sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Win-Ratio Analysis, 2-sided\n\n* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.\n* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352).'}], 'paramType': 'NUMBER', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the FDAC (Full-dose anticoagulation) arm to every patient in the SDPAC (Standard dose prophylactic anticoagulation) arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia.", 'unitOfMeasure': 'Number of wins', 'reportingStatus': 'POSTED', 'populationDescription': 'The on-treatment analysis population, consisting of all randomly assigned patients who received at least 1 dose of the randomly allocated study strategy. The on-treatment analysis population, consisting of all randomly assigned patients who received at least 1 dose of the randomly allocated study strategy. As is pre-specified in the Study Protocol, comparisons between FDAC and SDPAC are reported irrespective of whether participants received anti-platelet therapy.'}, {'type': 'PRIMARY', 'title': 'Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-platelet Therapy', 'description': 'Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days.\n\nReceived either FDAC( Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE; or Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours) or SDPAC (Enoxaparin 40 mg administered SC once daily (reduce to 30 mg if CrCl\\<30 ml/min)\\*; or Heparin 5,000 units administered SC three times daily).'}, {'id': 'OG001', 'title': 'No Anti-platelet Therapy', 'description': 'Participants did not receive anti-platelet therapy.\n\nReceived either FDAC( Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE; or Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours) or SDPAC (Enoxaparin 40 mg administered SC once daily (reduce to 30 mg if CrCl\\<30 ml/min)\\*; or Heparin 5,000 units administered SC three times daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '2052', 'groupId': 'OG000'}, {'value': '1994', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.54', 'ciUpperLimit': '2.01', 'statisticalMethod': 'Stratified Win-Ratio Analysis, 2-sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Win-Ratio Analysis, 2-sided\n\n* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.\n* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352).'}], 'paramType': 'NUMBER', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the Anti-platelet group to every patient in the No Anti-platelet group arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT.", 'unitOfMeasure': 'Number of wins', 'reportingStatus': 'POSTED', 'populationDescription': 'The on-treatment analysis population, consisting of all randomly assigned patients who received at least 1 dose of the randomly allocated study strategy. As is pre-specified in the Study Protocol, comparisons between anti-platelet therapy and no anti-platelet therapy are reported irrespective of which anticoagulation intervention participants received.'}, {'type': 'SECONDARY', 'title': 'Clinically Evident Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-platelet Therapy', 'description': 'Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days.\n\nReceived either FDAC( Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE; or Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours) or SDPAC (Enoxaparin 40 mg administered SC once daily (reduce to 30 mg if CrCl\\<30 ml/min)\\*; or Heparin 5,000 units administered SC three times daily)'}, {'id': 'OG001', 'title': 'No Anti-platelet Therapy', 'description': 'Participants did not receive anti-platelet therapy.\n\nReceived either FDAC( Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE; or Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours) or SDPAC (Enoxaparin 40 mg administered SC once daily (reduce to 30 mg if CrCl\\<30 ml/min)\\*; or Heparin 5,000 units administered SC three times daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '1452', 'groupId': 'OG000'}, {'value': '1900', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.65', 'statisticalMethod': 'Stratified Win-Ratio Analysis, 2-sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Win-Ratio Analysis, 2-sided\n\n* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.\n* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352).'}], 'paramType': 'NUMBER', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the Anti-platelet group to every patient in the No Anti-platelet group arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia.", 'unitOfMeasure': 'Number of wins', 'reportingStatus': 'POSTED', 'populationDescription': 'The on-treatment analysis population, consisting of all randomly assigned patients who received at least 1 dose of the randomly allocated study strategy. As is pre-specified in the Study Protocol, comparisons between anti-platelet therapy and no anti-platelet therapy are reported irrespective of which anticoagulation intervention participants received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Full-dose Anticoagulation (FDAC)', 'description': '* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of venous thrombotic event (VTE)\n* Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days'}, {'id': 'FG001', 'title': 'Standard-dose Prophylactic Anticoagulation (SDPAC)', 'description': '* Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if creatinine clearance CrCl\\<30 ml/min)\n* Heparin 5,000 units administered subcutaneous three times daily\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'Randomized to Anti-platelet Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'Randomized to no Antiplatelet Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '62'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '62'}]}]}], 'preAssignmentDetails': 'Patients were randomized in a 1:1 allocation ratio to receive either full-dose anticoagulation (FDAC) or standard-dose prophylactic anticoagulation (SDPAC). In a subset of patients without an ongoing indication for antiplatelet (AP) therapy at baseline, a second randomization was performed in a 1:1 allocation ratio to either AP or no AP therapy. Analyses of anticoagulation were pooled across AP regimens, and AP therapy vs. no AP therapy were pooled across anticoagulant regimens.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Full-dose Anticoagulation (FDAC)', 'description': '* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE\n* Enoxaparin 1 mg/kg administered subcutaneously(SC) every 12 hours\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days'}, {'id': 'BG001', 'title': 'Standard-dose Prophylactic Anticoagulation (SDPAC)', 'description': '* Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if CrCl\\<30 ml/min)\n* Heparin 5,000 units administered subcutaneous three times daily\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '70'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '68'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}, {'title': 'Non-white', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-28', 'size': 587260, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-27T16:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized-controlled trial - 1) full-dose anticoagulation (FDAC) versus standard-dose prophylactic anticoagulation (SDPAC) (pooled across antiplatelet regimens) and in a subset of patients 2) antiplatelet (AP) versus no AP therapy (pooled across anticoagulant regimens)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2020-05-28', 'resultsFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-22', 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the FDAC (Full-dose anticoagulation) arm to every patient in the SDPAC (Standard dose prophylactic anticoagulation) arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT."}, {'measure': 'Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the Anti-platelet group to every patient in the No Anti-platelet group arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT."}], 'secondaryOutcomes': [{'measure': 'Clinically Evident Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the FDAC (Full-dose anticoagulation) arm to every patient in the SDPAC (Standard dose prophylactic anticoagulation) arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia."}, {'measure': 'Clinically Evident Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy', 'timeFrame': '28 days or until hospital discharge, whichever earlier', 'description': "The efficacy of these interventions was analyzed using an unmatched win ratio.\n\n* The number of wins was found by comparing every patient in the Anti-platelet group to every patient in the No Anti-platelet group arm to determine a 'win' and totaling up the number of wins in each arm.\n* A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.\n* Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Venous Thromboembolism', 'Arterial Thrombosis']}, 'referencesModule': {'references': [{'pmid': '36036760', 'type': 'RESULT', 'citation': "Bohula EA, Berg DD, Lopes MS, Connors JM, Babar I, Barnett CF, Chaudhry SP, Chopra A, Ginete W, Ieong MH, Katz JN, Kim EY, Kuder JF, Mazza E, McLean D, Mosier JM, Moskowitz A, Murphy SA, O'Donoghue ML, Park JG, Prasad R, Ruff CT, Shahrour MN, Sinha SS, Wiviott SD, Van Diepen S, Zainea M, Baird-Zars V, Sabatine MS, Morrow DA; COVID-PACT Investigators. Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients With COVID-19: COVID-PACT. Circulation. 2022 Nov;146(18):1344-1356. doi: 10.1161/CIRCULATIONAHA.122.061533. Epub 2022 Aug 29."}, {'pmid': '37489818', 'type': 'DERIVED', 'citation': 'Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.'}, {'pmid': '35474746', 'type': 'DERIVED', 'citation': 'Lee CK, Merriam LT, Pearson JC, Lipnick MS, McKleroy W, Kim EY. Treating COVID-19: Evolving approaches to evidence in a pandemic. Cell Rep Med. 2022 Feb 9;3(3):100533. doi: 10.1016/j.xcrm.2022.100533. eCollection 2022 Mar 15.'}, {'pmid': '35244208', 'type': 'DERIVED', 'citation': 'Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The researchers wanted to learn how to help sick patients who are in the hospital because of COVID-19. They are trying to find out the best way that is safe to stop blood clots that could be dangerous from forming in patients with COVID-19. This research study happened at 34 hospitals.\n\nAll patients in the study took medicines that help prevent blood clots. These medicines are called blood thinners or anticoagulants. Patients got different amounts of blood thinners to see what works better and is safer. Researchers randomly chose some patients to get more and some to get less.\n\nThe researchers also wanted to know if another medicine called clopidogrel can safely help stop blood clots from forming. This kind of medicine helps keep parts of the blood, called platelets, from sticking together. In some patients who did not have other reasons to take a platelet-blocker the researchers randomly chose the patient to take clopidogrel or not. This type of medicine is also called an antiplatelet.', 'detailedDescription': 'This is a multicenter, open-label, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy (in a nested second randomization) for prevention of venous and arterial thrombotic events. In a subcohort without an ongoing indication for antiplatelet therapy at screening, the second randomization is performed to either antiplatelet or no antiplatelet therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years (male or female)\n2. Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)\n3. Currently admitted to an intensive care unit (ICU)\n\nKey Exclusion Criteria:\n\n1. Ongoing (\\>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication\n2. Ongoing or planned treatment with dual antiplatelet therapy\n3. Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:\n\n 1. History of intracranial hemorrhage, known central nervous system (CNS) tumor or CNS vascular abnormality\n 2. Active or recent major bleeding within the past 30 days with untreated source\n 3. Platelet count \\<70,000 or known functional platelet disorder\n 4. Fibrinogen \\<200 mg/dL\n 5. International normalized ratio (INR) \\>1.9\n4. History of heparin-induced thrombocytopenia\n5. Ischemic stroke within the past 2 weeks\n\nPatients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy):\n\n1\\. Ongoing or planned antiplatelet therapy, including aspirin monotherapy'}, 'identificationModule': {'nctId': 'NCT04409834', 'acronym': 'COVID-PACT', 'briefTitle': 'Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial', 'organization': {'class': 'OTHER', 'fullName': 'The TIMI Study Group'}, 'officialTitle': 'A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients', 'orgStudyIdInfo': {'id': 'CCCTN/TIMI COVID-PACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full-dose anticoagulation (FDAC)', 'description': '* Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an activated partial thromboplastin time (aPTT) of 1.5-2.5 times the control as per institutional therapeutic target for treatment of venous thrombotic events (VTE)\n* Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days', 'interventionNames': ['Drug: Unfractionated Heparin IV', 'Drug: Enoxaparin 1 mg/kg', 'Drug: Clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-dose prophylactic anticoagulation (SDPAC)', 'description': '* Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if creatinine clearance CrCl \\<30 ml/min)\n* Heparin 5,000 units administered subcutaneous three times daily\n* With or without anti-platelet therapy: Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily on subsequent days', 'interventionNames': ['Drug: Clopidogrel', 'Drug: Unfractionated heparin SC', 'Drug: Enoxaparin 40 mg SC']}], 'interventions': [{'name': 'Unfractionated Heparin IV', 'type': 'DRUG', 'description': 'Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE', 'armGroupLabels': ['Full-dose anticoagulation (FDAC)']}, {'name': 'Enoxaparin 1 mg/kg', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours', 'armGroupLabels': ['Full-dose anticoagulation (FDAC)']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily orally on subsequent days', 'armGroupLabels': ['Full-dose anticoagulation (FDAC)', 'Standard-dose prophylactic anticoagulation (SDPAC)']}, {'name': 'Unfractionated heparin SC', 'type': 'DRUG', 'description': 'Heparin 5,000 units administered subcutaneous three times daily', 'armGroupLabels': ['Standard-dose prophylactic anticoagulation (SDPAC)']}, {'name': 'Enoxaparin 40 mg SC', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if CrCl\\<30 ml/min)', 'armGroupLabels': ['Standard-dose prophylactic anticoagulation (SDPAC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02459', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Marc S Sabatine, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'The TIMI Study Group'}, {'name': 'David A Morrow, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The TIMI Study Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The TIMI Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}