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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00093184 |
The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.
Condition | Intervention | Phase |
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Myocardial Infarction |
Drug: Angiomax (bivalirudin) anticoagulant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients With ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptoms of STEMI for at least 30 min within previous 12 hours AND
Exclusion Criteria:
United States, Illinois | |
The Heart Care Research Foundation | |
Blue Island, Illinois, United States, 60406 |
Principal Investigator: | John F Stella, DO | Health Care Centers of Illinois |
Study ID Numbers: | TMC-BIV-04-01 |
Study First Received: | October 4, 2004 |
Last Updated: | February 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00093184 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ST-Segment Elevation Acute Myocardial Infarction PCI Percutaneous Coronary Intervention |
Necrosis Anticoagulants Heart Diseases Bivalirudin Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Heart Diseases Anticoagulants Myocardial Ischemia Hematologic Agents Vascular Diseases Ischemia Pharmacologic Actions |
Necrosis Pathologic Processes Bivalirudin Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction |