CURE Trial

Trial Categories: Acute Coronary Syndromes

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:

N Engl J Med. 2001 Aug 16;345(7):494-502.

Trial Details:

Eponym: 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

Related Links:

Review of Unstable Angina and Non-ST elevation MI