Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 4:55 AM
Study NCT ID:
NCT00433966
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2007-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular 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': 'C074619', 'term': 'bivalirudin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'obenyehuda@crf.org', 'phone': '646-434-4123', 'title': 'Ori Ben-Yehuda, MD, Executive Director, Clinical Trials Center', 'organization': 'Cardiovascular Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 Years', 'eventGroups': [{'id': 'EG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).', 'otherNumAtRisk': 1800, 'deathsNumAtRisk': 1800, 'otherNumAffected': 81, 'seriousNumAtRisk': 1800, 'deathsNumAffected': 102, 'seriousNumAffected': 397}, {'id': 'EG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).', 'otherNumAtRisk': 1802, 'deathsNumAtRisk': 1802, 'otherNumAffected': 132, 'seriousNumAtRisk': 1802, 'deathsNumAffected': 134, 'seriousNumAffected': 439}, {'id': 'EG002', 'title': 'Stent Arm - Paclitaxel-Eluting Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent', 'otherNumAtRisk': 2257, 'deathsNumAtRisk': 2257, 'otherNumAffected': 122, 'seriousNumAtRisk': 2257, 'deathsNumAffected': 123, 'seriousNumAffected': 473}, {'id': 'EG003', 'title': 'Stent Arm - Bare Metal Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent', 'otherNumAtRisk': 749, 'deathsNumAtRisk': 749, 'otherNumAffected': 32, 'seriousNumAtRisk': 749, 'deathsNumAffected': 48, 'seriousNumAffected': 185}], 'otherEvents': [{'term': 'Thrombolysis in Myocardial Infarction Minor Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 64, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 91, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 87, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Global Use of Strategies to Open Occluded Arteries Mild Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 113, 'numAffected': 110}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 109, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death (cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 88, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stent thrombosis (definite or probable)', 'notes': 'According to the Academic Research Consortium classification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 83, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 88, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 121, 'numAffected': 110}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 34, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia-driven target vessel revascularization (TVR)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 272, 'numAffected': 239}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 238, 'numAffected': 200}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 303, 'numAffected': 268}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 150, 'numAffected': 126}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia-driven target lesion revascularization (TLR)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 215, 'numAffected': 190}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 181, 'numAffected': 160}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 228, 'numAffected': 204}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 126, 'numAffected': 108}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia-driven TVR, non-TLR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 94, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 76, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 105, 'numAffected': 100}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major bleeing (protocol), non-coronary artery bypass grafting-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 149, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 207, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 213, 'numAffected': 189}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 68, 'numAffected': 56}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 132, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 150, 'numAffected': 124}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 123, 'numAffected': 105}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 43, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 156, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 212, 'numAffected': 193}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 179, 'numAffected': 165}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 55, 'numAffected': 46}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Global Use of Strategies to Open Occluded Arteries (GUSTO) Moderate Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1800, 'numEvents': 120, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1802, 'numEvents': 136, 'numAffected': 110}, {'groupId': 'EG002', 'numAtRisk': 2257, 'numEvents': 112, 'numAffected': 95}, {'groupId': 'EG003', 'numAtRisk': 749, 'numEvents': 41, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1800', 'groupId': 'OG000'}, {'value': '1802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'OG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}], 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stent Arm - Ischemic Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2257', 'groupId': 'OG000'}, {'value': '749', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stent Arm - Paclitaxel-Eluting Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}, {'id': 'OG001', 'title': 'Stent Arm - Bare Metal Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of Participants With Ischemic Target Lesion Revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2257', 'groupId': 'OG000'}, {'value': '749', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stent Arm - Paclitaxel-Eluting Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}, {'id': 'OG001', 'title': 'Stent Arm - Bare Metal Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacology Arm - Major Adverse Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1800', 'groupId': 'OG000'}, {'value': '1802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'OG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1800', 'groupId': 'OG000'}, {'value': '1802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'OG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stent Arm - Segment Binary Angiographic Restenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1062', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stent Arm - Paclitaxel-Eluting Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}, {'id': 'OG001', 'title': 'Stent Arm - Bare Metal Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 months', 'description': 'Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacology Arm - Major Adverse Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1800', 'groupId': 'OG000'}, {'value': '1802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'OG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}], 'classes': [{'categories': [{'measurements': [{'value': '379', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'FG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'FG002', 'title': 'Stent Arm - Paclitaxel-Eluting Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}, {'id': 'FG003', 'title': 'Stent Arm - Bare Metal Stent', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months\n\nBare metal stent: Uncoated bare metal stent\n\nPaclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent'}], 'periods': [{'title': 'Pharmacology Intervention/Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1800'}, {'groupId': 'FG001', 'numSubjects': '1802'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '30-Day Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1787'}, {'groupId': 'FG001', 'numSubjects': '1791'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '1-Year Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1696'}, {'groupId': 'FG001', 'numSubjects': '1702'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '3-Year Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1634'}, {'groupId': 'FG001', 'numSubjects': '1628'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1634'}, {'groupId': 'FG001', 'numSubjects': '1628'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Not true myocardial infarction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Stent Intervention/Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2257'}, {'groupId': 'FG003', 'numSubjects': '749'}]}, {'type': '1-Year Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2186'}, {'groupId': 'FG003', 'numSubjects': '715'}]}, {'type': '3-Year Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2103'}, {'groupId': 'FG003', 'numSubjects': '687'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2103'}, {'groupId': 'FG003', 'numSubjects': '687'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '154'}, {'groupId': 'FG003', 'numSubjects': '62'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '47'}]}]}], 'recruitmentDetails': 'Between March 25, 2005, and May 7, 2007, 3602 patients with STEMI undergoing primary percutaneous coronary intervention were enrolled at 123 academic or community-based medical centers in 11 countries.', 'preAssignmentDetails': 'Random, open-label assignment (1:1 ratio) to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. After emergency angiography and triage to PCI, CABG, or GDMT, eligible patients were randomly assigned (3:1 ratio) to either paclitaxel-eluting stents or uncoated, bare-metal stents.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1800', 'groupId': 'BG000'}, {'value': '1802', 'groupId': 'BG001'}, {'value': '3602', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pharmacology Arm - Bivalirudin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'BG001', 'title': 'Pharmacology Arm - Unfractionated Heparin', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.\n\nBivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).\n\nUnfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'groupId': 'BG000', 'lowerLimit': '51.9', 'upperLimit': '69.5'}, {'value': '60.7', 'groupId': 'BG001', 'lowerLimit': '52.9', 'upperLimit': '70.1'}, {'value': '60.2', 'groupId': 'BG002', 'lowerLimit': '52.4', 'upperLimit': '69.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '412', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '842', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1388', 'groupId': 'BG000'}, {'value': '1372', 'groupId': 'BG001'}, {'value': '2760', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline data is presented by first randomization (pharmacology).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3602}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2007-02-09', 'resultsFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2007-02-09', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-30', 'studyFirstPostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events', 'timeFrame': '30 Days', 'description': 'Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).'}, {'measure': 'Stent Arm - Ischemic Target Lesion Revascularization', 'timeFrame': '1 year', 'description': 'Number of Participants With Ischemic Target Lesion Revascularization'}, {'measure': 'Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis', 'timeFrame': '1 year', 'description': 'Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis'}], 'secondaryOutcomes': [{'measure': 'Pharmacology Arm - Major Adverse Cardiovascular Events', 'timeFrame': '30 days', 'description': 'Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)'}, {'measure': 'Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding', 'timeFrame': '30 days', 'description': 'Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)'}, {'measure': 'Stent Arm - Segment Binary Angiographic Restenosis', 'timeFrame': '13 months', 'description': 'Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).'}, {'measure': 'Pharmacology Arm - Major Adverse Cardiovascular Events', 'timeFrame': '3 years', 'description': 'Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Angioplasty', 'Myocardial Ischemia', 'Myocardial Reperfusion', 'Stents', 'Heart Disease'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '28724652', 'type': 'DERIVED', 'citation': 'Kosmidou I, McAndrew T, Redfors B, Embacher M, Dizon JM, Mehran R, Ben-Yehuda O, Mintz GS, Stone GW. Correlation of Admission Heart Rate With Angiographic and Clinical Outcomes in Patients With Right Coronary Artery ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: HORIZONS-AMI (The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial. J Am Heart Assoc. 2017 Jul 19;6(7):e006181. doi: 10.1161/JAHA.117.006181.'}, {'pmid': '28249084', 'type': 'DERIVED', 'citation': 'Tamez H, Pinto DS, Kirtane AJ, Litherland C, Yeh RW, Dangas GD, Mehran R, Deliargyris EN, Ortiz G, Gibson CM, Stone GW. Effect of Short Procedural Duration With Bivalirudin on Increased Risk of Acute Stent Thrombosis in Patients With STEMI: A Secondary Analysis of the HORIZONS-AMI Randomized Clinical Trial. JAMA Cardiol. 2017 Jun 1;2(6):673-677. doi: 10.1001/jamacardio.2016.5669.'}, {'pmid': '27287251', 'type': 'DERIVED', 'citation': "Ducrocq G, Steg PG, Van't Hof A, Zeymer U, Mehran R, Hamm CW, Bernstein D, Prats J, Deliargyris EN, Stone GW. Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):659-665. doi: 10.1177/2048872616650869. Epub 2016 Jun 10."}, {'pmid': '27165710', 'type': 'DERIVED', 'citation': "Dangas GD, Schoos MM, Steg PG, Mehran R, Clemmensen P, van 't Hof A, Prats J, Bernstein D, Deliargyris EN, Stone GW. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials. Circ Cardiovasc Interv. 2016 May;9(5):e003272. doi: 10.1161/CIRCINTERVENTIONS.115.003272."}, {'pmid': '26458411', 'type': 'DERIVED', 'citation': 'Weisz G, Smilowitz NR, Kirtane AJ, Rinaldi MJ, Parvataneni R, Xu K, Stuckey TD, Maehara A, Witzenbichler B, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Mazzaferri EL Jr, Mehran R, Stone GW. Proton Pump Inhibitors, Platelet Reactivity, and Cardiovascular Outcomes After Drug-Eluting Stents in Clopidogrel-Treated Patients: The ADAPT-DES Study. Circ Cardiovasc Interv. 2015 Oct;8(10):e001952. doi: 10.1161/CIRCINTERVENTIONS.114.001952.'}, {'pmid': '26198286', 'type': 'DERIVED', 'citation': 'Giacoppo D, Madhavan MV, Baber U, Warren J, Bansilal S, Witzenbichler B, Dangas GD, Kirtane AJ, Xu K, Kornowski R, Brener SJ, Genereux P, Stone GW, Mehran R. Impact of Contrast-Induced Acute Kidney Injury After Percutaneous Coronary Intervention on Short- and Long-Term Outcomes: Pooled Analysis From the HORIZONS-AMI and ACUITY Trials. Circ Cardiovasc Interv. 2015 Aug;8(8):e002475. doi: 10.1161/CIRCINTERVENTIONS.114.002475.'}, {'pmid': '25858976', 'type': 'DERIVED', 'citation': 'Nikolsky E, Mehran R, Dangas GD, Xu K, Parvataneni R, Witzenbichler B, Guagliumi G, Kornowski R, Genereux P, Brener SJ, Stone GW. Cerebrovascular events after a primary percutaneous coronary intervention strategy for acute ST-segment-elevation myocardial infarction: analysis from the HORIZONS-AMI Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002283. doi: 10.1161/CIRCINTERVENTIONS.114.002283.'}, {'pmid': '25572507', 'type': 'DERIVED', 'citation': "Stone GW, Mehran R, Goldstein P, Witzenbichler B, Van't Hof A, Guagliumi G, Hamm CW, Genereux P, Clemmensen P, Pocock SJ, Gersh BJ, Bernstein D, Deliargyris EN, Steg PG. Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: pooled patient-level analysis from the HORIZONS-AMI and EUROMAX trials. J Am Coll Cardiol. 2015 Jan 6;65(1):27-38. doi: 10.1016/j.jacc.2014.10.029."}, {'pmid': '25179260', 'type': 'DERIVED', 'citation': 'Sanborn TA, Tomey MI, Mehran R, Genereux P, Witzenbichler B, Brener SJ, Kirtane AJ, McAndrew TC, Kornowski R, Dudek D, Nikolsky E, Stone GW. Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: results from the HORIZONS-AMI trial. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):371-9. doi: 10.1002/ccd.25663. Epub 2014 Oct 28.'}, {'pmid': '24939928', 'type': 'DERIVED', 'citation': 'Stone SG, Serrao GW, Mehran R, Tomey MI, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Mockel M, Brener SJ, Dangas G, Stone GW. Incidence, predictors, and implications of reinfarction after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction: the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial. Circ Cardiovasc Interv. 2014 Aug;7(4):543-51. doi: 10.1161/CIRCINTERVENTIONS.114.001360. Epub 2014 Jun 17.'}, {'pmid': '24703369', 'type': 'DERIVED', 'citation': 'Keeley EC, Mehran R, Brener SJ, Witzenbichler B, Guagliumi G, Dudek D, Kornowski R, Dressler O, Fahy M, Xu K, Grines CL, Stone GW. Impact of multiple complex plaques on short- and long-term clinical outcomes in patients presenting with ST-segment elevation myocardial infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Trial). Am J Cardiol. 2014 May 15;113(10):1621-7. doi: 10.1016/j.amjcard.2014.02.016. Epub 2014 Mar 1.'}, {'pmid': '24576541', 'type': 'DERIVED', 'citation': 'Larsen AI, Tomey MI, Mehran R, Nilsen DW, Kirtane AJ, Witzenbichler B, Guagliumi G, Brener SJ, Genereux P, Kornowski R, Dudek D, Gersh BJ, Stone GW. Comparison of outcomes in patients with ST-segment elevation myocardial infarction discharged on versus not on statin therapy (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trial). Am J Cardiol. 2014 Apr 15;113(8):1273-9. doi: 10.1016/j.amjcard.2014.01.401. Epub 2014 Jan 31.'}, {'pmid': '24561145', 'type': 'DERIVED', 'citation': 'Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.'}, {'pmid': '24140664', 'type': 'DERIVED', 'citation': 'Stone GW, Clayton T, Deliargyris EN, Prats J, Mehran R, Pocock SJ. Reduction in cardiac mortality with bivalirudin in patients with and without major bleeding: The HORIZONS-AMI trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction). J Am Coll Cardiol. 2014 Jan 7-14;63(1):15-20. doi: 10.1016/j.jacc.2013.09.027. Epub 2013 Oct 16.'}, {'pmid': '24093847', 'type': 'DERIVED', 'citation': 'Brener SJ, Dizon JM, Mehran R, Guerchicoff A, Lansky AJ, Farkouh M, Brodie B, Guagliumi G, Witzenbichler B, Fahy M, Parise H, Stone GW. Complementary prognostic utility of myocardial blush grade and ST-segment resolution after primary percutaneous coronary intervention: analysis from the HORIZONS-AMI trial. Am Heart J. 2013 Oct;166(4):676-83. doi: 10.1016/j.ahj.2013.07.025. Epub 2013 Sep 13.'}, {'pmid': '24084625', 'type': 'DERIVED', 'citation': 'Palmerini T, Brener SJ, Mehran R, Dangas G, Genereux P, Riva DD, Mariani A, Xu K, Stone GW. Leukocyte count is a modulating factor for the mortality benefit of bivalirudin in ST-segment-elevation acute myocardial infarction: the HORIZONS-AMI trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):518-26. doi: 10.1161/CIRCINTERVENTIONS.113.000592. Epub 2013 Oct 1.'}, {'pmid': '23652600', 'type': 'DERIVED', 'citation': 'Farkouh ME, Reiffel J, Dressler O, Nikolsky E, Parise H, Cristea E, Baran DA, Dizon J, Merab JP, Lansky AJ, Mehran R, Stone GW. Relationship between ST-segment recovery and clinical outcomes after primary percutaneous coronary intervention: the HORIZONS-AMI ECG substudy report. Circ Cardiovasc Interv. 2013 Jun;6(3):216-23. doi: 10.1161/CIRCINTERVENTIONS.112.000142. Epub 2013 May 7.'}, {'pmid': '23538158', 'type': 'DERIVED', 'citation': 'Rakowski T, Dudek D, Dziewierz A, Yu J, Witzenbichler B, Guagliumi G, Kornowski R, Hartmann F, Lansky AJ, Brener SJ, Mehran R, Stone GW. Impact of infarct-related artery patency before primary PCI on outcome in patients with ST-segment elevation myocardial infarction: the HORIZONS-AMI trial. EuroIntervention. 2013 Mar;8(11):1307-14. doi: 10.4244/EIJV8I11A199.'}, {'pmid': '23518872', 'type': 'DERIVED', 'citation': 'Caixeta A, Lansky AJ, Mehran R, Brener SJ, Claessen B, Genereux P, Palmerini T, Witzenbichler B, Guagliumi G, Brodie BR, Dudek D, Fahy M, Dangas GD, Stone GW; Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial investigators. Predictors of suboptimal TIMI flow after primary angioplasty for acute myocardial infarction: results from the HORIZONS-AMI trial. EuroIntervention. 2013 Jun 22;9(2):220-7. doi: 10.4244/EIJV9I2A37.'}, {'pmid': '23425539', 'type': 'DERIVED', 'citation': 'Tobbia P, Brodie BR, Witzenbichler B, Metzger C, Guagliumi G, Yu J, Kellett MA, Stuckey T, Fahy M, Mehran R, Stone GW. Adverse event rates following primary PCI for STEMI at US and non-US hospitals: three-year analysis from the HORIZONS-AMI trial. EuroIntervention. 2013 Feb 22;8(10):1134-42. doi: 10.4244/EIJV8I10A176.'}, {'pmid': '23359554', 'type': 'DERIVED', 'citation': 'Dudek D, Mehran R, Dziewierz A, Witzenbichler B, Brodie BR, Kornowski R, Fahy M, Lansky AJ, Rakowski T, Legutko J, Bryniarski L, Stone GW. Impact of advanced age on the safety and effectiveness of paclitaxel-eluting stent implantation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty: The HORIZONS-AMI trial. Catheter Cardiovasc Interv. 2013 Nov 15;82(6):869-77. doi: 10.1002/ccd.24813. Epub 2013 Aug 1.'}, {'pmid': '23339809', 'type': 'DERIVED', 'citation': 'Dangas GD, Claessen BE, Mehran R, Xu K, Stone GW. Stent thrombosis after primary angioplasty for STEMI in relation to non-adherence to dual antiplatelet therapy over time: results of the HORIZONS-AMI trial. EuroIntervention. 2013 Jan 22;8(9):1033-9. doi: 10.4244/EIJV8I9A159.'}, {'pmid': '23328566', 'type': 'DERIVED', 'citation': 'Zhao Z, Witzenbichler B, Mintz GS, Jaster M, Choi SY, Wu X, He Y, Margolis MP, Dressler O, Cristea E, Parise H, Mehran R, Stone GW, Maehara A. Dynamic nature of nonculprit coronary artery lesion morphology in STEMI: a serial IVUS analysis from the HORIZONS-AMI trial. JACC Cardiovasc Imaging. 2013 Jan;6(1):86-95. doi: 10.1016/j.jcmg.2012.08.010.'}, {'pmid': '23192919', 'type': 'DERIVED', 'citation': 'Jarai R, Dangas G, Huber K, Xu K, Brodie BR, Witzenbichler B, Metzger DC, Radke PW, Yu J, Claessen BE, Genereux P, Mehran R, Stone GW. B-type natriuretic peptide and risk of contrast-induced acute kidney injury in acute ST-segment-elevation myocardial infarction: a substudy from the HORIZONS-AMI trial. Circ Cardiovasc Interv. 2012 Dec;5(6):813-20. doi: 10.1161/CIRCINTERVENTIONS.112.972356. Epub 2012 Nov 27.'}, {'pmid': '23174632', 'type': 'DERIVED', 'citation': 'Dangas GD, Claessen BE, Mehran R, Xu K, Fahy M, Parise H, Henriques JP, Ohman EM, White HD, Stone GW. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes. JACC Cardiovasc Interv. 2012 Nov;5(11):1097-105. doi: 10.1016/j.jcin.2012.07.012.'}, {'pmid': '22795245', 'type': 'DERIVED', 'citation': 'Planer D, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Xu K, Fahy M, Mehran R, Stone GW. Impact of hyperglycemia in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: the HORIZONS-AMI trial. 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Am Heart J. 2008 Jul;156(1):44-56. doi: 10.1016/j.ahj.2008.02.008.'}, {'pmid': '18499566', 'type': 'DERIVED', 'citation': 'Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008 May 22;358(21):2218-30. doi: 10.1056/NEJMoa0708191.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of the trial are:\n\n1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy.\n2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.', 'detailedDescription': 'Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions eligible for stenting will then undergo a second randomization (3:1) to stent implantation with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise identical uncoated bare metal stent (EXPRESS2™).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting \\>20 minutes but \\<12 hours in duration;\n* ST-segment elevation of \\>1 mm in \\>2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \\>1 mm in \\>2 contiguous anterior leads;\n* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.\n\nExclusion Criteria:\n\n* The patient has a known hypersensitivity or contraindication to any of the following medications:\n\n * Heparin, pork or pork products\n * Both abciximab and eptifibatide\n * Aspirin\n * Both Clopidogrel and Ticlopidine\n * Bivalirudin\n * Paclitaxel or Taxol\n * The polymer components of the TAXUS™ stent (SIBS)\n * Stainless steel and/or\n * Contrast media;\n* Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;\n* Current use of coumadin;\n* Systemic (intravenous) Paclitaxel or Taxol use within 12 months;\n* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;\n* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;\n* History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;\n* Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;\n* Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;\n* Recent history or known current platelet count \\<100,000 cells/mm3 or Hgb \\<10 g/dL;\n* Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;\n* An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;\n* Non-cardiac co-morbid conditions are present with life expectancy \\<1 year or that may result in protocol non-compliance;\n* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;\n* Previous enrollment in this trial;\n* Patients who underwent coronary stent implantation within the past 30 days.'}, 'identificationModule': {'nctId': 'NCT00433966', 'briefTitle': 'Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular Research Foundation, New York'}, 'officialTitle': 'Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary Angioplasty With Stent Implantation With Either a Slow Rate-release Paclitaxel-eluting Stent (TAXUS™) or Uncoated Bare Metal Stent (EXPRESS2™)', 'orgStudyIdInfo': {'id': 'HORIZONS AMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacology Arm', 'description': 'To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:\n\n1. reduced rates of major bleeding events at 30 days\n2. similar rates of major adverse ischemic cardiac events at 30 days\n3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.', 'interventionNames': ['Drug: Bivalirudin', 'Drug: Unfractionated heparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stent Arm', 'description': 'To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:\n\n1. reduced rates of target lesion revascularization for ischemia at 1 year\n2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year\n3. lower rates of analysis segment binary angiographic restenosis at 13 months', 'interventionNames': ['Device: Bare metal stent', 'Device: Paclitaxel-eluting stent']}], 'interventions': [{'name': 'Bivalirudin', 'type': 'DRUG', 'otherNames': ['Angiomax'], 'description': 'Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).', 'armGroupLabels': ['Pharmacology Arm']}, {'name': 'Unfractionated heparin', 'type': 'DRUG', 'otherNames': ['Heparin Sodium'], 'description': '60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).', 'armGroupLabels': ['Pharmacology Arm']}, {'name': 'Bare metal stent', 'type': 'DEVICE', 'otherNames': ['EXPRESS2™'], 'description': 'Uncoated bare metal stent', 'armGroupLabels': ['Stent Arm']}, {'name': 'Paclitaxel-eluting stent', 'type': 'DEVICE', 'otherNames': ['TAXUS™'], 'description': 'slow rate-release paclitaxel-eluting stent', 'armGroupLabels': ['Stent Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'LeBauer CV Research Foundation', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}], 'overallOfficials': [{'name': 'Gregg W Stone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CardioVascular Research Foundation'}, {'name': 'Roxana Mehran, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CardioVascular Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Research Foundation, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, {'name': 'The Medicines Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}