Acute Coronary Syndromes
Conditions
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 who have already had a heart attack that was treated with fibrinolytic therapy.
Interventions
plus acetylsalicylic acid (ASA)
DRUGPlacebo
plus acetylsalicylic acid (ASA)
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* STEMI within 12 hours of randomization * Planned treatment with a fibrinolytic agent and aspirin
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy: composite of an included infarct-related artery on the pre-discharge angiogram, or death or recurrent MI by the time of the start of coronary angiography | — |
| safety: TIMI major bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic, clinical and electrocardiographic outcomes | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed