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| Sponsor: | Cardiovascular Research Foundation, New York |
|---|---|
| Collaborators: |
Boston Scientific Corporation The Medicines Company |
| Information provided by: | Cardiovascular Research Foundation, New York |
| ClinicalTrials.gov Identifier: | NCT00433966 |
Purpose
The primary objectives of the trial are:
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | HORIZONS AMI |
| Study First Received: | February 9, 2007 |
| Last Updated: | May 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00433966 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Myocardial Infarction Angioplasty Myocardial Ischemia |
Myocardial Reperfusion Stents Heart Disease |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Heparin, Low-Molecular-Weight Myocardial Ischemia Hematologic Agents Fibrinolytic Agents Necrosis Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Cardiovascular Diseases Heparin Myocardial Infarction |
Heart Diseases Anticoagulants Mitosis Modulators Vascular Diseases Ischemia Cardiovascular Agents Antimitotic Agents Pharmacologic Actions Paclitaxel Bivalirudin Tubulin Modulators Infarction Antineoplastic Agents, Phytogenic |