CHARISMA
Conclusions
Clopidogrel plus ASA failed to show superiority over ASA alone in reducing the primary endpoint (MI, stroke, or CV death)
Primary prevention in patients with risk-factors:
- Significant excess in death (P=0.04) and CV mortality (P=0.01) with clopidogrel treatment
- Excess in bleeding rate with dual anti-platelet therapy
Secondary prevention:
- Moderately significant benefit in clopidogrel + ASA arm (P=0.04)
- No significant benefit in each of the 3 disease-related pre-specified secondary endpoints (stroke, MI, PAD)
Safety analysis:
- Significantly higher rate of moderate bleedings with clopidogrel + ASA (P<0.001)
