Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)
Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
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.