Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

Phase 3

Completed

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: Clopidogrel (SR25990); Drug: Placebo

• Registration Number: NCT00714961
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-07-10
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-14
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3491

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clopidogrel (SR25990)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Angiographic, clinical and electrocardiographic outcomes

Trial Locations

Locations (16)

sanofi-aventis South Africa; 🇿🇦 Midrand, South Africa

sanofi-aventis Poland; 🇵🇱 Warszawa, Poland

sanofi-aventis Belgium; 🇧🇪 Diegem, Belgium

sanofi-aventis Germany; 🇩🇪 Berlin, Germany

Sanofi-Aventis Hungaria; 🇭🇺 Budapest, Hungary

sanofi-aventis Netherlands; 🇳🇱 Gouda, Netherlands

Sanofi-Aventis Mexico; 🇲🇽 Mexico, Mexico

sanofi-aventis Brazil; 🇧🇷 Sao Paulo, Brazil

sanofi-aventis Canada; 🇨🇦 Laval, Canada

sanofi-aventis Austria; 🇦🇹 Vienna, Austria

Sanofi-Aventis; 🇹🇷 Istanbul, Turkey

sanofi-aventis Italy; 🇮🇹 Milano, Italy

sanofi-aventis France; 🇫🇷 Paris, France

sanofi-aventis Spain; 🇪🇸 Barcelona, Spain

sanofi-aventis UK; 🇬🇧 Guildford, United Kingdom

sanofi-aventis Sweden; 🇸🇪 Bromma, Sweden