Document Detail

Clopidogrel added to aspirin versus aspirin alone in secondary prevention and high-risk primary prevention: rationale and design of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial.
MedLine Citation:
PMID:  15308995     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Clopidogrel is a more potent antiplatelet agent than aspirin, resulting in greater clinical efficacy in patients with atherothrombotic disease. Furthermore, the combination of clopidogrel plus aspirin has been demonstrated to be superior to aspirin alone in the treatment of patients with acute coronary syndromes and after coronary stenting. Whether dual antiplatelet therapy is superior to aspirin monotherapy for high-risk primary prevention and secondary prevention is unknown. METHODS AND RESULTS: The Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) study was designed to evaluate the efficacy and safety of clopidogrel plus aspirin versus placebo plus aspirin in patients with established coronary, cerebral, or peripheral arterial disease or in patients with multiple risk factors for atherothrombosis who have not yet sustained an ischemic event. This randomized, international, multicenter, double-blinded, placebo-controlled study has finished enrolling patients worldwide. A total of 15,603 patients will be followed long term. The primary end point will be the composite of vascular death, myocardial infarction, or stroke. Rates of severe bleeding will also be compared between the two arms of the study. CONCLUSIONS: This large-scale trial of patients at high risk for atherothrombotic events will allow determination of the value of a strategy of adding clopidogrel to the current standard of care, including low-dose aspirin, for a wide spectrum of patients with atherothrombosis.
Deepak L Bhatt; Eric J Topol;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  148     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2004 Aug 
Date Detail:
Created Date:  2004-08-13     Completed Date:  2005-01-13     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  263-8     Citation Subset:  AIM; IM    
Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
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MeSH Terms
Arteriosclerosis / complications,  drug therapy*,  prevention & control
Aspirin / therapeutic use*
Cardiovascular Diseases / mortality,  prevention & control
Drug Therapy, Combination
Middle Aged
Platelet Aggregation Inhibitors / therapeutic use*
Primary Prevention
Randomized Controlled Trials as Topic
Research Design
Risk Factors
Thrombosis / complications,  drug therapy*,  prevention & control
Ticlopidine / analogs & derivatives*,  therapeutic use*
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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