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OpenTrials
Completed

NCT Number: NCT00714961

Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

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.

Completed

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel (SR25990)

Drug

plus acetylsalicylic acid (ASA)

Placebo

Drug

plus acetylsalicylic acid (ASA)

Primary outcomes

  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 outcomes

  1. Angiographic, clinical and electrocardiographic outcomes

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Acronym: CLARITY-TIMI28

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 14, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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