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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714961
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : March 25, 2009
Bristol-Myers Squibb
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: Clopidogrel (SR25990) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2003
Primary Completion Date : January 2005
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Clopidogrel (SR25990)
plus acetylsalicylic acid (ASA)
Placebo Comparator: 2 Drug: Placebo
plus acetylsalicylic acid (ASA)

Primary Outcome Measures :
  1. 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
  2. safety: TIMI major bleeding

Secondary Outcome Measures :
  1. Angiographic, clinical and electrocardiographic outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714961

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

Publications of Results:
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
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic