METHODS AND RESULTS: Combined data from randomized trials of thienopyrindines in patients with atherosclerotic disease demonstrated a 29% reduction in vascular events when compared with placebo/control (n=2392) (OR 0.71, 95% CI 0.58-0.86, P=0.0006) and
a 10% reduction in vascular events when compared with
aspirin (n=22 254) (OR 0.91, 95% Cl 0.84-0.99, P=0.039). Similarly, randomized trials of
aspirin plus
thienopyridines in patients undergoing intracoronary stenting, demonstrated a marked benefit of
aspirin plus
ticlopidine in reducing death or
myocardial infarction compared with
aspirin alone (OR 0.23, 95% CI 0.11-0.49, P=0.0001) or
aspirin plus
warfarin (OR 0.51, 95% CI 0.33-0.78, P=0.002). Whether these benefits extend to the much larger population of patients with
acute coronary syndrome is unknown. CURE is an international, randomized, double-blind trial, in which patients with
acute coronary syndrome will be randomized to receive either a bolus dose of
clopidogrel (300 mg) followed by 75 mg per day for 3-12 months, or matching placebo. Both groups will receive
aspirin. The co-primary efficacy end-points of CURE are: (1) the composite of cardiovascular death,
myocardial infarction or
stroke; and (2) the composite of cardiovascular death,
myocardial infarction,
stroke or refractory ischaemia. CURE will recruit approximately 12 500 patients with
acute coronary syndrome (from 28 countries) and its power to detect moderate treatment benefits will be in the region of 80-90%, while maintaining an overall type I error (alpha) of 0.05. The baseline characteristics of the study population are consistent with at least a moderate risk group of patients with
acute coronary syndrome.
CONCLUSIONS: