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:
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Within 24 hours of symptom onset
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No ST segment elevation
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New ischemic ECG changes OR elevation in cardiac enzymes
Exclusion Criteria:
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Contraindication to antithrombotic or antiplatelet therapy
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High bleeding risk
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Severe heart failure
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Patients taking oral anticoagulants
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Coronary revascularization within the previous 3 months
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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:
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Severe ischemia
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Heart failure
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Need for revascularization
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Life-threatening bleeding
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Major bleeding (requiring 2 or more units of blood transfusion)
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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.