Status:
COMPLETED
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Acute Coronary Syndromes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the combination of aspirin plus clopidogrel is more effective than aspirin alone in preventing another heart attack, chest pain, stroke or death in people ...
Eligibility Criteria
Inclusion
- STEMI within 12 hours of randomization
- Planned treatment with a fibrinolytic agent and aspirin
Exclusion
- Intention of performing coronary angiography within 48 hours of fibrinolysis
- Treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, or planned treatment with clopidogrel or ticlopidine.
- Contraindication to fibrinolysis
- Planned use of a glycoprotein IIb/IIIa inhibitor
- Prior CABG
- Evidence of cardiogenic shock or acute pulmonary edema requiring intubation or an intraaortic balloon pump
- Known renal or hepatic insufficiency
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
3491 Patients enrolled
Trial Details
Trial ID
NCT00714961
Start Date
February 1 2003
End Date
January 1 2005
Last Update
March 25 2009
Active Locations (24)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Buenos Aires, Argentina
3
Sanofi-Aventis
Macquarie Park, Australia
4
sanofi-aventis Austria
Vienna, Austria