CHARISMA trial

Introduction

Study characteristics:

• 15,603 patients with either
  • clinical cardiovascular disease
  • multiple cardiac risk factors
• median age 64 years, range 39-95
• 30% women

Treatment groups:

• clopidogrel 75 mg QD plus aspirin 75-162 mg QD
• placebo plus aspirin 75-162 mg QD

Duration of trial: median of 28 months

Primary endpoint: composite of

• myocardial infarction
• stroke
• death from cardiovascular causes

Results:

• clopidogrel plus aspirin not significantly more effective than aspirin alone in reducing the rate of primary end point
• non-statistically significant trends of
  • benefit with clopidogrel treatment in patients with symptomatic atherothrombosis
  • harm with clopidogrel treatment in patients with multiple risk factors

• indications for combined aspirin 81 mg plus clopidogrel:
  • acute coronary syndrome
  • s/p coronary stent

* ClinicalTrials.gov number, NCT00050817.

More general terms

• clinical trial

Additional terms

• aspirin (Ecotrin, Empirin, Bayer aspirin, Vazalore, ASA)
• clopidogrel (Plavix)