MedWire News: Giving acute transient ischemic attack (TIA) patients clopidogrel in addition to aspirin may reduce their risk for early stroke, results from the FASTER trial suggest.
The FASTER (Fast Assessment of Stroke and TIA to prevent Early Recurrence) pilot trial aimed to randomly assign patients within 24 hours of TIA or minor stroke onset to receive a clopidogrel 300-mg loading dose followed by 75 mg daily or matching placebo, or simvastatin or matching placebo, in addition to aspirin 81 mg.
Alastair Buchan (John Radcliffe Hospital, Oxford, UK) and colleagues explain that the study was halted early because high use of statins in the general patient population slowed the trial recruitment to below the prespecified minimum rate. Of the 2705 patients excluded, 27.4% were not enrolled because they were already using a statin.
The findings, which appear in The Lancet Neurology, are therefore based on 392 patients.
During the 90 days after enrollment, 7.1% of patients on clopidogrel suffered stroke compared with 10.8% of those taking matching placebo, as did 10.6% and 7.3% of patients on simvastatin and its placebo, respectively.
The absolute risk reduction for stroke was 3.8% for clopidogrel versus placebo, and the risk ratio was 0.7. The absolute risk increase was 3.3% for simvastatin versus placebo and the risk ratio was 1.5. None of these associations were statistically significant, however.
Two patients receiving clopidogrel suffered intracranial hemorrhage, compared with no patient taking placebo - a 1.0% nonsignificant increase in absolute risk.
In an accompanying comment, S Claiborne Johnston (University of California at San Francisco, USA) called the clopidogrel findings "tantalizing."
He noted that previous large-scale trials did not find a benefit of combination antiplatelet treatment over aspirin alone in patients with stroke and TIA, but stressed that these trials did not begin antiplatelet treatment acutely. Furthermore, subgroup analyses suggested that the degree of risk reduction associated with antiplatelet treatment increased with decreasing time between the qualifying event and trial enrollment.
"These data, when taken together with the findings from FASTER, suggest that treatment with a combination of clopidogrel and aspirin might be beneficial when taken soon after a TIA or minor stroke," said Johnston.
"Of course, these data are only suggestive, because they are derived from small pilot studies and subgroup analyses, and they should not be taken as proof of clinical utility, but they do provide strong support for a large-scale clinical trial."
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