Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction (CLARITY-TIMI28)

March 24, 2009 updated by: Sanofi

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

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 Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

3491

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Sanofi-Aventis
      • Macquarie Park, Australia
        • Sanofi-Aventis
      • Vienna, Austria
        • sanofi-aventis Austria
      • Diegem, Belgium
        • sanofi-aventis Belgium
      • Sao Paulo, Brazil
        • sanofi-aventis Brazil
      • Laval, Canada
        • sanofi-aventis Canada
      • Paris, France
        • Sanofi-Aventis France
      • Berlin, Germany
        • Sanofi-aventis Germany
      • Budapest, Hungary
        • sanofi-aventis Hungaria
      • Dublin, Ireland
        • Sanofi-Aventis
      • Natanya, Israel
        • Sanofi-Aventis
      • Milano, Italy
        • sanofi-aventis Italy
      • Mexico, Mexico
        • Sanofi-Aventis Mexico
      • Gouda, Netherlands
        • sanofi-aventis Netherlands
      • Warszawa, Poland
        • sanofi-aventis Poland
      • Porto, Portugal
        • Sanofi-Aventis
      • Puerto Rico, Puerto Rico
        • Sanofi-Aventis
      • Moscow, Russian Federation
        • Sanofi-Aventis
      • Midrand, South Africa
        • sanofi-aventis South Africa
      • Barcelona, Spain
        • sanofi-aventis Spain
      • Bromma, Sweden
        • sanofi-aventis Sweden
      • Istanbul, Turkey
        • Sanofi-Aventis
      • Guildford, United Kingdom
        • Sanofi-Aventis UK
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
plus acetylsalicylic acid (ASA)
Placebo Comparator: 2
plus acetylsalicylic acid (ASA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
Angiographic, clinical and electrocardiographic outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Eugene Braunwald, MD, Brigham and Women's Hospital, Boston, MA, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndromes

Clinical Trials on Clopidogrel (SR25990)

3
Subscribe