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

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Sanofi Identifier:
First received: July 10, 2008
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Acute Coronary Syndromes
Drug: Clopidogrel (SR25990)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • Angiographic, clinical and electrocardiographic outcomes

Enrollment: 3491
Study Start Date: February 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Clopidogrel (SR25990)
plus acetylsalicylic acid (ASA)
Placebo Comparator: 2 Drug: Placebo
plus acetylsalicylic acid (ASA)


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00714961

  Show 24 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Principal Investigator: Eugene Braunwald, MD Brigham and Women's Hospital, Boston, MA, USA
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00714961     History of Changes
Other Study ID Numbers: EFC5133, CV149-015
Study First Received: July 10, 2008
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Signs and Symptoms
Vascular Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015