AHA Statement
03/15/2006

American Heart Association Statement: Patient Guidance Based on Results of the CHARISMA Trial

Since the results of the CHARISMA trial were published on Sunday, the American Heart Association has received a number of questions from patients seeking guidance on whether they need to take any action based on the study.

The CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance) trial investigated whether people with major vascular risks, including various combinations of conventional risk factors such as high blood pressure and high cholesterol and events such as heart attack, stroke, and peripheral arterial disease, do better with two antiplatelet agents or aspirin alone.  

Results from the trial were presented during the American College of Cardiology meeting in Atlanta.

According to Ralph Sacco, M.D., a spokesperson for the American Heart Association/American Stroke Association, “This trial does not support the addition of clopidogrel to aspirin therapy in patients with stable cardiovascular disease orin the case of prevention, those at high risk for cardiovascular disease.  For the total group, no significant reduction in heart attack, stroke orcardiovascular death was seen with clopidogrel and aspirin versus aspirin alone, and the combination of clopidogrelwith aspirin was associated with a significantly increased risk of moderate (requiring transfusion) or severe bleeding in those taking the combination for primary prevention.”

While there was a suggestion of benefit in the subgroup of patients who had already had a heart attack, stroke, or who had symptomatic peripheral arterial disease, this needs further study before it changes what patients and doctors should do. “It is important to remember, however, that previous trials have documented the benefits of combined treatment with clopidogrel and aspirin for other groups of patients – those with heart attack or unstable angina (also called unstable coronary syndromes) and those who have had coronary angioplasty with stent placement,” Sacco said.

“Patients who are currently taking clopidogrel, aspirin, or the combination for approved indications should not stop their medications,” he said.  “If you have questions about your medications, talk to your doctor.”

This year an estimated 1,200,000 Americans will have a new or recurrent coronary attack and another 700,000 people will have a new or recurrent stroke.

Clopidogrel may be prescribedby a doctor for:

• some patients who have had a heart attack;
• patients who have had angioplasty for unstable angina or heart attack,
• patients who have received a bare metal stent, or drug- coated stent,
• patients with peripheral artery disease; or
• patients who have had a transient ischemic attack (mini stroke) or some other types of stroke.

The use of clopidogrel, aspirin, and all other heart medications shouldcontinue to remain at your doctor’s judgment.

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