CURE
Trial question
What is the role of clopidogrel in patients with acute coronary syndromes without ST-segment elevation receiving aspirin?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 12562
12562 patients (4836 female, 7726 male).
Inclusion criteria: patients with acute coronary syndromes without ST-segment elevation receiving aspirin.
Key exclusion criteria: contraindications to antithrombotic or antiplatelet therapy, high risk for bleeding or severe HF, receipt of OACs, and coronary revascularization in the previous 3 months.
Interventions
N=6259 clopidogrel (300 mg immediately, followed by 75 mg once daily).
N=6303 placebo (matching placebo daily).
Primary outcome
CV death, nonfatal MI, or stroke
9.3%
11.4%
11.4 %
8.6 %
5.7 %
2.9 %
0.0 %
Clopidogrel
Placebo
Significant
decrease ▼
NNT = 47
Significant decrease in CV death, nonfatal MI, or stroke (9.3% vs. 11.4%; RR 0.8, 95% CI 0.72 to 0.9).
Secondary outcomes
Significant decrease in refractory ischemia, CV death, nonfatal MI, or stroke (16.5% vs. 18.8%; RR 0.86, 95% CI 0.79 to 0.94).
Significant increase in major bleeding (3.7% vs. 2.7%; RR 1.38, 95% CI 1.13 to 1.67).
Safety outcomes
No significant differences in life-threatening bleeding (2.2% vs. 1.8%, p=0.13) or hemorrhagic stroke (0.1% vs. 0.1%).
Significant differences in major bleeding (3.7% vs. 2.7%, p = 0.001; RR 1.38).
Conclusion
In patients with acute coronary syndromes without ST-segment elevation receiving aspirin, clopidogrel was superior to placebo with respect to CV death, nonfatal MI, or stroke.
Reference
Yusuf S, Zhao F, Mehta SR et al. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502.
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