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

Completed · Phase 3

Conditions studied: Arteriosclerosis

In brief

RATIONALE: * Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death. * In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients. * The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis. OBJECTIVES: * To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily). * To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.

Key facts

Study ID

NCT00050817

Run by

Sanofi

People needed

15603

Starts

2002-10-01

Expected to finish

2005-08-01

Last updated by the study team

2012-04-23

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Sanofi-aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-aventis Administrative Office — Macquarie Park, Australia
• Sanofi-aventis Administrative Office — Vienna, Austria
• Sanofi-aventis Administrative Office — Diegem, Belgium
• Sanofi-aventis Administrative Office — São Paulo, Brazil
• Sanofi-aventis Administrative Office — Laval, Canada
• Sanofi-aventis Administrative Office — Santiago, Chile
• Sanofi-aventis Administrative Office — Prague, Czechia
• Sanofi-aventis Administrative Office — Hørsholm, Denmark
• Sanofi-aventis Administrative Office — Helsinki, Finland
• Sanofi-aventis Administrative Office — Paris, France
• Sanofi-aventis Administrative Office — Berlin, Germany
• Sanofi-aventis Administrative Office — Athens, Greece
• Sanofi-aventis Administrative Office — Causeway Bay, Hong Kong
• Sanofi-aventis Administrative Office — Budapest, Hungary
• Sanofi-aventis Administrative Office — Milan, Italy
• Sanofi-aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-aventis Administrative Office — México, Mexico
• Sanofi-aventis Administrative Office — Gouda, Netherlands
• Sanofi-aventis Administrative Office — Lysaker, Norway
• Sanofi-aventis Administrative Office — Warsaw, Poland
• Sanofi-aventis Administrative Office — Porto Salvo, Portugal
• Sanofi-aventis Administrative Office — Moscow, Russia
• Sanofi-aventis Administrative Office — Singapore, Singapore

Full record on ClinicalTrials.gov

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