CHARISMA
Trial question
What is the effect of combination of clopidogrel and aspirin in patients with high-risk for atherothrombotic events?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 15603
15603 patients (4644 female, 10959 male).
Inclusion criteria: patients with either clinically evident CVD or multiple risk factors for atherothrombotic events.
Key exclusion criteria: receipt of oral antithrombotic medications or nonsteroidal antiinflammatory drugs on a long-term basis, recent acute coronary syndrome, or requirement of clopidogrel after revascularization procedure.
Interventions
N=7802 clopidogrel and aspirin (clopidogrel 75 mg/day and aspirin 75-162 mg/day).
N=7801 aspirin (aspirin 75-162 mg/day plus matching placebo).
Primary outcome
MI, stroke, or CV death
6.8%
7.3%
7.3 %
5.5 %
3.6 %
1.8 %
0.0 %
Clopidogrel and
aspirin
Aspirin
No significant
difference ↔
No significant difference in MI, stroke, or CV death (6.8% vs. 7.3%; RR 0.93, 95% CI 0.83 to 1.05).
Secondary outcomes
Significant decrease in hospitalizations for ischemic events (16.7% vs. 17.9%; RR 0.92, 95% CI 0.86 to 0.99).
No significant difference in MI, stroke, or CV death, in patients with multiple risk factors (6.6% vs. 5.5%; RR 1.2, 95% CI 0.91 to 1.59).
Safety outcomes
Significant differences in severe bleeding (1.7% vs. 1.3%, p = 0.09; RR 1.25, 95% CI 0.97-1.61).
Conclusion
In patients with either clinically evident CVD or multiple risk factors for atherothrombotic events, clopidogrel and aspirin were not superior to aspirin with respect to MI, stroke, or CV death.
Reference
Bhatt DL, Fox KA, Hacke W et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17.
Open reference URL