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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: Bare metal stent Device: Paclitaxel-eluting stent |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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™) |
| Enrollment: | 3604 |
| Study Start Date: | March 2005 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pharmacology Arm
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:
|
Drug: Bivalirudin
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).
Other Name: Angiomax
Drug: Unfractionated heparin
60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
Other Name: Heparin Sodium
|
|
Active Comparator: Stent Arm
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:
|
Device: Bare metal stent
Uncoated bare metal stent
Other Name: EXPRESS2™
Device: Paclitaxel-eluting stent
slow rate-release paclitaxel-eluting stent
Other Name: TAXUS™
|
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™).
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
| Responsible Party: | Gregg W. Stone, MD, Cardiovascular Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00433966 History of Changes |
| Other Study ID Numbers: | HORIZONS AMI |
| Study First Received: | February 9, 2007 |
| Last Updated: | December 10, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Myocardial Infarction Angioplasty Myocardial Ischemia |
Myocardial Reperfusion Stents Heart Disease |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Calcium heparin Bivalirudin Heparin Paclitaxel Anticoagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Antineoplastic Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |