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CHARISMA trial
Study characteristics:
1) 15,603 patients with either
a) clinical cardiovascular disease
b) multiple cardiac risk factors
2) median age 64 years, range 39-95
3) 30% women
Treatment groups:
1) clopidogrel 75 mg QD plus aspirin 75-162 mg QD
2) placebo plus aspirin 75-162 mg QD
Duration of trial: median of 28 months
Primary endpoint: composite of
1) myocardial infarction
2) stroke
3) death from cardiovascular causes
Results:
1) clopidogrel plus aspirin not significantly more effective than aspirin alone in reducing the rate of primary end point
2) non-statistically significant trends of
a) benefit with clopidogrel treatment in patients with symptomatic atherothrombosis
b) harm with clopidogrel treatment in patients with multiple risk factors
3) indications for combined aspirin 81 mg plus clopidogrel:
a) acute coronary syndrome
b) s/p coronary stent
* ClinicalTrials.gov number, NCT00050817.
Related
aspirin (Ecotrin, Empirin, Bayer aspirin, Vazalore, ASA)
clopidogrel (Plavix)
General
clinical trial
References
- Bhatt DL et al,
Clopidogrel and Aspirin versus Aspirin Alone for the Prevention
of Atherothrombotic Events.
N Engl J Med. 2006 Mar 21; [Epub ahead of print]
PMID: 16531616
http://dx.doi.org/10.1056/NEJMoa060989
- Pfeffer MA & Jarcho JA.
The CHARISMA of subgroups and the subgroups of CHARISMA
N Engl J Med 2006 Apr 20; 354
http://dx.doi.org/10.1056/NEJMe068061
- Prescriber's Letter 13(5): 2006
When to use aspirin with clopidogrel
Detail-Document#: 220509
(subscription needed) http://www.prescribersletter.com