Status:
COMPLETED
Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Lead Sponsor:
Cardiovascular Research Foundation, New York
Collaborating Sponsors:
Boston Scientific Corporation
The Medicines Company
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objectives of the trial are: 1. 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/I...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting \>20 minutes but \<12 hours in duration;
- 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;
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin, pork or pork products
- Both abciximab and eptifibatide
- Aspirin
- Both Clopidogrel and Ticlopidine
- Bivalirudin
- Paclitaxel or Taxol
- The polymer components of the TAXUS™ stent (SIBS)
- Stainless steel and/or
- Contrast media;
- 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;
- Current use of coumadin;
- Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
- History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
- Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
- Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
- Recent history or known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL;
- Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance;
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- Previous enrollment in this trial;
- Patients who underwent coronary stent implantation within the past 30 days.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
3602 Patients enrolled
Trial Details
Trial ID
NCT00433966
Start Date
March 1 2005
End Date
November 1 2010
Last Update
December 4 2017
Active Locations (1)
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1
LeBauer CV Research Foundation
Greensboro, North Carolina, United States, 27401