Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3491 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Clopidogrel (SR25990)

Intervention Type DRUG

plus acetylsalicylic acid (ASA)

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

plus acetylsalicylic acid (ASA)

Interventions

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Clopidogrel (SR25990)

plus acetylsalicylic acid (ASA)

Intervention Type DRUG

Placebo

plus acetylsalicylic acid (ASA)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Eugene Braunwald, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital, Boston, MA, USA

Guildford, , United Kingdom

Site Status

Countries

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United States 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