Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)

Completed

Phase 3 Results

Results

In this trial, there was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors. Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes. The rate of the primary efficacy end point was 6.8% with clopidogrel plus aspirin and 7.3% with placebo plus aspirin (P = 0.22). The respective rate of the principal secondary efficacy end point, which included hospitalizations for ischemic events, was 16.7% and 17.9% (P = 0.04), and the rate of severe bleeding was 1.7% and 1.3% (P = 0.09). The rate of the primary end point among patients with multiple risk factors was 6.6% with clopidogrel and 5.5% with placebo (P = 0.20) and the rate of death from cardiovascular causes also was higher with clopidogrel (P = 0.01). In the subgroup with clinically evident atherothrombosis, the rate was 6.9% with clopidogrel and 7.9% with placebo (P = 0.046). Conclusion: overall, clopidogrel plus aspirin was not more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes.