Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

Last updated: March 24, 2009
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Heart Disease

Chest Pain

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT00714961
EFC5133
CV149-015
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • STEMI within 12 hours of randomization

  • Planned treatment with a fibrinolytic agent and aspirin

Exclusion

Exclusion Criteria:

  • Intention of performing coronary angiography within 48 hours of fibrinolysis

  • Treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, orplanned 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 anintraaortic balloon pump

  • Known renal or hepatic insufficiency

Study Design

Total Participants: 3491
Study Start date:
February 01, 2003
Estimated Completion Date:
January 31, 2005

Connect with a study center

  • Sanofi-Aventis

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanofi-Aventis

    Macquarie Park,
    Australia

    Site Not Available

  • sanofi-aventis Austria

    Vienna,
    Austria

    Site Not Available

  • sanofi-aventis Belgium

    Diegem,
    Belgium

    Site Not Available

  • sanofi-aventis Brazil

    Sao Paulo,
    Brazil

    Site Not Available

  • sanofi-aventis Canada

    Laval,
    Canada

    Site Not Available

  • sanofi-aventis France

    Paris,
    France

    Site Not Available

  • sanofi-aventis Germany

    Berlin,
    Germany

    Site Not Available

  • Sanofi-Aventis Hungaria

    Budapest,
    Hungary

    Site Not Available

  • Sanofi-Aventis

    Dublin,
    Ireland

    Site Not Available

  • Sanofi-Aventis

    Natanya,
    Israel

    Site Not Available

  • sanofi-aventis Italy

    Milano,
    Italy

    Site Not Available

  • Sanofi-Aventis Mexico

    Mexico,
    Mexico

    Site Not Available

  • sanofi-aventis Netherlands

    Gouda,
    Netherlands

    Site Not Available

  • sanofi-aventis Poland

    Warszawa,
    Poland

    Site Not Available

  • Sanofi-Aventis

    Porto,
    Portugal

    Site Not Available

  • Sanofi-Aventis

    Puerto Rico,
    Puerto Rico

    Site Not Available

  • Sanofi-Aventis

    Moscow,
    Russian Federation

    Site Not Available

  • sanofi-aventis South Africa

    Midrand,
    South Africa

    Site Not Available

  • sanofi-aventis Spain

    Barcelona,
    Spain

    Site Not Available

  • sanofi-aventis Sweden

    Bromma,
    Sweden

    Site Not Available

  • Sanofi-Aventis

    Istanbul,
    Turkey

    Site Not Available

  • sanofi-aventis UK

    Guildford,
    United Kingdom

    Site Not Available

  • Sanofi-Aventis

    Bridgewater, New Jersey 08807
    United States

    Site Not Available

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