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Sponsors and Collaborators: |
Cardiovascular Research Foundation, New York Boston Scientific Corporation The Medicines Company |
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Information provided by: | Cardiovascular Research Foundation, New York |
ClinicalTrials.gov Identifier: | NCT00433966 |
The primary objectives of the trial are:
Condition | Intervention | Phase |
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Myocardial Infarction |
Drug: Bivalirudin Drug: Unfractionated heparin Device: Uncoated bare metal stent (EXPRESS2™) Device: Paclitaxel-eluting stent (TAXUS™) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | 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™) |
Estimated Enrollment: | 3400 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2011 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications:
United States, North Carolina | |
LeBauer CV Research Foundation | |
Greensboro, North Carolina, United States, 27401 |
Principal Investigator: | Gregg W Stone, MD | CardioVascular Research Foundation, Korea |
Study Director: | Roxana Mehran, MD | CardioVascular Research Foundation, Korea |
Study ID Numbers: | HORIZONS AMI |
Study First Received: | February 9, 2007 |
Last Updated: | May 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00433966 |
Health Authority: | United States: Food and Drug Administration |
Myocardial Infarction Angioplasty Myocardial Ischemia |
Myocardial Reperfusion Stents Heart Disease |
Heart Diseases Myocardial Ischemia Heparin, Low-Molecular-Weight Vascular Diseases Ischemia Calcium heparin Necrosis |
Paclitaxel Bivalirudin Emergencies Infarction Myocardial Infarction Heparin |
Anticoagulants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Agents Mitosis Modulators Fibrinolytic Agents Cardiovascular Agents Antimitotic Agents |
Pharmacologic Actions Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Tubulin Modulators Cardiovascular Diseases Antineoplastic Agents, Phytogenic |