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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndromes

Treatments: Drug: Placebo; Drug: Clopidogrel (SR25990)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00714961

EFC5133

CV149-015

Details and patient eligibility

About

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.

Enrollment: 3,491 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,491 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Clopidogrel (SR25990)

2

Placebo Comparator group

Treatment:

Drug: Placebo