Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

Acute Coronary Syndromes Clinical Trial

— CLARITY-TIMI28  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714961
• Other study ID #: EFC5133
• Secondary ID: CV149-015
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2008
• Last updated: March 24, 2009
• Start date: February 2003
• Est. completion date: January 2005

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3491
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Myocardial Infarction

Intervention

Drug:
• Clopidogrel (SR25990)
plus acetylsalicylic acid (ASA)
• Placebo
plus acetylsalicylic acid (ASA)

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	Buenos Aires
Australia	Sanofi-Aventis	Macquarie Park
Austria	sanofi-aventis Austria	Vienna
Belgium	sanofi-aventis Belgium	Diegem
Brazil	sanofi-aventis Brazil	Sao Paulo
Canada	sanofi-aventis Canada	Laval
France	sanofi-aventis France	Paris
Germany	sanofi-aventis Germany	Berlin
Hungary	Sanofi-Aventis Hungaria	Budapest
Ireland	Sanofi-Aventis	Dublin
Israel	Sanofi-Aventis	Natanya
Italy	sanofi-aventis Italy	Milano
Mexico	Sanofi-Aventis Mexico	Mexico
Netherlands	sanofi-aventis Netherlands	Gouda
Poland	sanofi-aventis Poland	Warszawa
Portugal	Sanofi-Aventis	Porto
Puerto Rico	Sanofi-Aventis	Puerto Rico
Russian Federation	Sanofi-Aventis	Moscow
South Africa	sanofi-aventis South Africa	Midrand
Spain	sanofi-aventis Spain	Barcelona
Sweden	sanofi-aventis Sweden	Bromma
Turkey	Sanofi-Aventis	Istanbul
United Kingdom	sanofi-aventis UK	Guildford
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Countries where clinical trial is conducted

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, 

References & Publications (1)

Sabatine MS, Cannon CP, Gibson CM, López-Sendón 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 infarcti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	safety: TIMI major bleeding
Secondary	Angiographic, clinical and electrocardiographic outcomes