A multicentre RCT 1 of 45 852 patients with acute myocardial infarction was carried out in 1 250 hospitals in China. Patients admitted to care within 24 h of suspected infarction onset were randomly allocated to clopidogrel 75 mg daily or placebo in addition to aspirin 162 mg daily. 93% had ST-segment elevation or bundle branch block, and 7% had ST-segment depression. Clopidogrel produced a 9% (95% CI 3-14) proportional reduction in death, reinfarction, or stroke (2 121 [9.2%] clopidogrel vs. 2 310 [10.1%] placebo; p=0.002), corresponding to 9 fewer events per 1 000 patients treated for about 2 weeks, as well as a 7% (1-13) proportional reduction in any death (1 726 [7.5%] vs. 1 845 [8.1%]; p=0.03). No significant excess risk was noted with clopidogrel, either overall (134 [0.58%] vs. 125 [0.55%]; p=0.59), or in patients aged older than 70 years or in those given fibrinolytic therapy.
In a multicentre placebo-controlled RCT of clopidogrel in patients receiving fibrinolytics for STEMI, a prospectively planned analysis of the 1 863 patients undergoing PCI after mandated angiography was performed 2. Patients received aspirin and were randomized to either clopidogrel (300 mg loading dose, then 75 mg once daily) or placebo initiated with fibrinolysis and given until coronary angiography was performed after 2 to 8 days. During 30 days follow-up, pretreatment with clopidogrel resulted in a reduction in cardiovascular death, MI, or stroke: 70 (7.5%) vs. 112 (12.0%), adjusted OR 0.59 (95% CI, 0.43-0.81); p =0.001; NNT=23. The reduction was evident both prior to PCI (OR 0.62) and following PCI (OR 0.54). There was no significant excess in the rates of major or minor bleeding (18 (2.0%) vs. 17 (1.9%); P>0.99).
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