October 5, 2011 (Bethesda, Maryland) - The aspirin-clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) arm of a randomized secondary-prevention trial of patients with subcortical stroke has been halted by the sponsoring National Institute of Neurological Disorders and Stroke (NINDS), the institute has announced .
The Secondary Prevention of Small Subcortical Strokes (SPS3) trial had randomized 3020 patients in North America, Latin America, and Spain to receive clopidogrel 75 mg/day on top of aspirin 325 mg/day vs aspirin alone. All patients had experienced a symptomatic, imaging-verified "small" subcortical stroke within the past six months.
With enrollment completed in April of this year, a scheduled data review in June found a 6.5% rate of bleeding events in the double-antiplatelet arm compared with 3.3% in the aspirin-alone group (p<0.001).
The rates of major non-central-nervous-system (CNS) bleeding were 5.5% in the dual antiplatelet arm vs 2.5% in the aspirin-alone arm; all-cause mortality was 5.8% and 4.1% (p=0.04). "In addition, a futility analysis showed little likelihood of benefit in favor of aspirin plus clopidogrel on recurrent stroke should the study continue to conclusion," according to the NINDS clinical advisory.
"These results support current guidelines that recommend against the use of the combination of clopidogrel plus aspirin for secondary stroke prevention and now extend this advice to those with recent small subcortical strokes, or lacunar infarcts, that have been confirmed by MRI."
Patients had been separately randomized to blood-pressure management with a systolic BP target of either 130 to 149 or <130 to explore effects on recurrent stroke and cognition. The trial's data safety and monitoring board "strongly recommended that the blood-pressure intervention component of the trial be continued without modification." Its completion is expected in April, 2012, according to the NINDS statement.
Heartwire from Medscape © 2011 Medscape, LLC
Cite this: Clopidogrel-Aspirin Arm Halted in SPS3 Stroke Trial - Medscape - Oct 05, 2011.