Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00714961
First received: July 10, 2008
Last updated: March 24, 2009
Last verified: March 2009
History of Changes

July 10, 2008
March 24, 2009
February 2003
January 2005   (final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT00714961 on ClinicalTrials.gov Archive Site
Angiographic, clinical and electrocardiographic outcomes
Same as current
Not Provided
Not Provided
 
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Coronary Syndromes
  • Drug: Clopidogrel (SR25990)
    plus acetylsalicylic acid (ASA)
  • Drug: Placebo
    plus acetylsalicylic acid (ASA)
  • Experimental: 1
    Intervention: Drug: Clopidogrel (SR25990)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3491
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
 
NCT00714961
EFC5133, CV149-015
Yes
ICD Study Director, sanofi-aventis
Sanofi
Bristol-Myers Squibb
Principal Investigator: Eugene Braunwald, MD Brigham and Women's Hospital, Boston, MA, USA
Sanofi
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP