Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

Sanofi3,491 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

3,491

Conditions

Acute Coronary Syndromes

Interventions

Clopidogrel (SR25990)DRUG

plus acetylsalicylic acid (ASA)

PlaceboDRUG

plus acetylsalicylic acid (ASA)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (24)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Sanofi-Aventis

Buenos Aires, Argentina

Outcomes

Primary Outcomes

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 Outcomes

Angiographic, clinical and electrocardiographic outcomes

Data from ClinicalTrials.gov

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