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| |  Can Aspirin With Clopidogrel or Statins Reduce Recurrent Stroke Risk? Presented at ESC By Rachel Tilley GLASGOW, UK -- June 5, 2007 -- Researchers showed that combined aspirin and clopidogrel taken within 24 hours of stroke onset reduced recurrent stroke, but statins appeared ineffective in early stroke prevention. The research was presented here at the 16th annual European Stroke Conference (ESC). Evidence shows that over half of the 3-month risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor stroke is gained within the first 72 hours. The Fast Assessment of Stroke and Transient Ischemic attack (TIA) to prevent early recurrence (FASTER) trial was designed to determine the effects of early aggressive intervention with a combination of antiplatelet therapy and high-dose statin therapy immediately following minor stroke or TIA. The results of the pilot phase were presented by James Kennedy, MB, MSc, MRCP, director, the FASTER trial, Nuffield Department of Clinical Medicine, University of Oxford, UK. The Canadian Institute of Health Research, who is the major sponsor, required a pilot phase with the aim of determining enrolment feasibility, safety, and efficacy. "They did not think the study was feasible," said Dr. Kennedy. This concern was based on the scepticism of the true event rate in these patients at the time and subsequent patient enrolment. They also had concerns over patient safety due to the combination of antiplatelet therapy. Initially, 2,285 patients were assessed and 2,489 were excluded from the study because the majority were on clopidogrel, anticoagulants, or taking statins. The remaining patients (n=390) were randomised after a TIA or minor stroke (NIHSS <3.0) within a 2x2 factorial designed double-blind controlled trial. All patients were either on or received aspirin (162 mg loading and 81 mg daily). Patients also received either clopidogrel (300 mg loading plus 75 mg daily) or its placebo and simvastatin (40 mg daily) or its placebo within 24 hours of stroke onset for the duration of 90 days. In patients receiving clopidogrel, a 3.7% risk reduction in recurrent stroke was observed compared with its placebo, and the risk reduction was more marked when the patients were also taking the simvastatin placebo (5.1%) rather than the active drug (9%). In contrast, a 3.3% increase in the risk of stroke was observed in patients taking the active simvastatin (10.6%) compared with placebo (7.3%). Overall, only two early events, within 7 days, were observed in the patients with TIA and 35 recurrent stroke events were observed over the duration of the study. The researchers found significantly higher bleeding rates in patients receiving clopidogrel (P <.001) compared with the placebo. These were attributable to two intercranial hemorrhages (1%) and severe (0.5%), moderate (1%), and mild (0.5%) systemic hemorrhages in the clopidogrel group, whereas no symptomatic hemorrhages were seen in the placebo group. Also, asymptomatic hemorrhages, or bruising, were observed in 30.8% of the patients taking clopidogrel compared with 13.9% of the placebo group. Patients taking active simvastatin were not affected by myalgia any more than those taking the simvastatin placebo. This study was closed early because statins are increasingly being used and therefore the investigators failed to meet the enrolment criteria. "Clopidogrel and aspirin reduced the risk of stroke following TIA or minor stroke, and there is an unlikely significant effect in stroke prevention with early statin use," said Dr. Kennedy. However, both conclusions need to be confirmed in a larger study, he added. Merck provided the active simvastatin and its placebo and Sanofi-Aventis provided clopidogrel and its placebo. The study was sponsored by the Canadian Institute of Health Research.
[Presentation title: The Fast Assessment of Stroke and Transient ischemic attack (TIA) to prevent Early Recurrence (FASTER) Trial – Results of the Pilot Phase. Abstract 05 Large Clinical Trials]
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