NCT00714961
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Clopidogrel Plus Acetylsalicylic Acid (ASA) Versus ASA Alone in Subjects With Acute ST Elevation Myocardial Infarction (STEMI) Treated With Fibrinolytic Therapy
ConditionsAcute Coronary Syndromes
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 3,491
- Locations
- 16
- Primary Endpoint
- safety: TIMI major bleeding
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Experimental
Intervention: Clopidogrel (SR25990) (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
safety: TIMI major bleeding
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
Secondary Outcomes
- Angiographic, clinical and electrocardiographic outcomes
Investigators
Study Sites (16)
Loading locations...
Similar Trials
Completed
Phase 3
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionSAcute Coronary DiseaseAngina UnstableNCT00335452Sanofi25,086
Completed
Phase 1
Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)Healthy VolunteersNCT01108588Merck Sharp & Dohme LLC15
Completed
Phase 3
Acetylsalicylic Acid Combined With Pseudoephedrine in Common ColdCommon ColdNCT00963443Bayer833
Completed
Phase 4
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3Coronary Artery DiseaseNCT04418479Joo-Yong Hahn5,506
Completed
Phase 4
Clopidogrel and Aspirin Interaction Study-2Drug Action IncreasedNCT01341964Population Health Research Institute302