NEW YORK (Reuters Health) – In high vascular risk patients, addition of clopidogrel to treatment with acetylsalicylic acid does not help minimize untoward events, researchers report in the August issue of Stroke.

“Long term use of clopidogrel plus aspirin in combination,” Dr. Graeme J. Hankey told Reuters Health by email, “is no more effective than aspirin alone is reducing the rate or severity of stroke among patients with stable vascular disease.”

Dr. Hankey of Royal Perth Hospital, Australia and colleagues examined data on 15,603 patients who had been randomized to receive clopidogrel 75 mg/d or placebo in addition to background acetylsalicylic acid.

After a median of 28 months of follow-up, 202 clopidogrel and 234 placebo patients had a stroke, for a nonsignificant risk reduction with clopidogrel of 14% (p=0.12). At 3 months, there were no differences in the functional severity of stroke outcome events as measured by the modified Rankin Scale.

Among a subgroup of 4320 patients enrolled with a qualifying diagnosis of transient ischemic attack or ischemic stroke, 233 (5.4%) experienced a stroke (i.e., a recurrent stroke for patients who qualified with stroke) during follow-up. Of these, 103 were assigned clopidogrel and 130 placebo; the 20% risk reduction was not statistically different. Again there were no differences in modified Rankin Scale scores at 3 months.

Thus the researchers conclude, “This trial fails to provide evidence that adding clopidogrel to acetylsalicylic acid significantly reduces the severity of stroke outcome events.”

Reference:
Effect of Clopidogrel on the Rate and Functional Severity of Stroke Among High Vascular Risk Patients. A Prespecified Substudy of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Trial
Stroke 2010;41.