- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714961
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
Conditions
Intervention / Treatment
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
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Buenos Aires, Argentina
- Sanofi-Aventis
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Macquarie Park, Australia
- Sanofi-Aventis
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Vienna, Austria
- sanofi-aventis Austria
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Diegem, Belgium
- sanofi-aventis Belgium
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Sao Paulo, Brazil
- sanofi-aventis Brazil
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Laval, Canada
- sanofi-aventis Canada
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Paris, France
- Sanofi-Aventis France
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Berlin, Germany
- Sanofi-aventis Germany
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Budapest, Hungary
- sanofi-aventis Hungaria
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Dublin, Ireland
- Sanofi-Aventis
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Natanya, Israel
- Sanofi-Aventis
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Milano, Italy
- sanofi-aventis Italy
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Mexico, Mexico
- Sanofi-Aventis Mexico
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Gouda, Netherlands
- sanofi-aventis Netherlands
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Warszawa, Poland
- sanofi-aventis Poland
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Porto, Portugal
- Sanofi-Aventis
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Puerto Rico, Puerto Rico
- Sanofi-Aventis
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Moscow, Russian Federation
- Sanofi-Aventis
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Midrand, South Africa
- sanofi-aventis South Africa
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Barcelona, Spain
- sanofi-aventis Spain
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Bromma, Sweden
- sanofi-aventis Sweden
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Istanbul, Turkey
- Sanofi-Aventis
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Guildford, United Kingdom
- Sanofi-Aventis UK
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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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 |
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Experimental: 1
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plus acetylsalicylic acid (ASA)
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Placebo Comparator: 2
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plus acetylsalicylic acid (ASA)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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safety: TIMI major bleeding
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Secondary Outcome Measures
Outcome Measure |
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Angiographic, clinical and electrocardiographic outcomes
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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.
General Publications
- Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.
- Harkness JR, Sabatine MS, Braunwald E, Morrow DA, Sloan S, Wiviott SD, Giugliano RP, Antman EM, Cannon CP, Scirica BM. Extent of ST-segment resolution after fibrinolysis adds improved risk stratification to clinical risk score for ST-segment elevation myocardial infarction. Am Heart J. 2010 Jan;159(1):55-62. doi: 10.1016/j.ahj.2009.10.033.
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
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- EFC5133
- CV149-015
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.
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