Trial Details:

Acronym: Clopidogrel in Unstable angina to prevent Recurrent Events

Purpose: The evaluate clopidogrel (Plavix) when added to aspirin during unstable angina or non-ST segment elevation myocardial infarction.

Format: Double-blind, multicenter, randomized control trial

Treatment Group: Clopidogrel

Control Group: Placebo

Number of Patients: 12,562

Inclusion Criteria: 

• Within 24 hours of symptom onset
• No ST segment elevation
• New ischemic ECG changes OR elevation in cardiac enzymes

Exclusion Criteria:

• Contraindication to antithrombotic or antiplatelet therapy
• High bleeding risk
• Severe heart failure
• Patients taking oral anticoagulants
• Coronary revascularization within the previous 3 months
• Patients that had received glycoprotein IIb/IIIa inhibitors within the prior 3 days

Follow-up: Three to twelve months

Primary endpoint: Composite of cardiovascualr death, non-fatal MI and stroke

Secondary endpoint:

• Severe ischemia
• Heart failure
• Need for revascularization
• Life-threatening bleeding
• Major bleeding (requiring 2 or more units of blood transfusion)
• Minor bleeding

Summary:

Evaluated clopidogrel versus placebo added to aspirin during non-ST elevation MI or unstable angina. There was a significant reduction in the composite endpoint of death from cardiovascular causes, nonfatal MI, and stroke. The CURE trial led to the recommended to use clopidogrel as medical management for non-ST elevation myocardial infarctions and unstable angina.

Original Publication:

Yusuf S, et al. N Engl J Med. 2001 Aug 16;345(7):494-502.