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SPS3: Secondary Prevention of Small Subcortical Strokes 

Sponsor: NIH

Investigators: Carlos Kase MD (principal), Viken Babikian MD, Jose Romero MD

N Engl J Med 2012; 367:817-825 August 30, 2012

SPS3 was a double-blind, multicenter trial involving 3020 patients with recent symptomatic lacunar infarcts identified by magnetic resonance imaging. Patients were randomly assigned to receive 75 mg of clopidogrel or placebo daily; patients in both groups received 325 mg of aspirin daily. The primary outcome was any recurrent stroke, including ischemic stroke and intracranial hemorrhage. In conclusion, in this clinical trial of clopidogrel and aspirin, as compared with aspirin alone, in patients with a recent lacunar stroke identified on MRI, it was found that the anticipated increase in the risk of major hemorrhage with dual antiplatelet therapy was not offset by a reduction in the risk of stroke recurrence, and there was an unexpected increase in mortality. Additional results from the component of the SPS3 trial involving blood pressure control are anticipated in 2012.

The Lancet, Volume 382, Issue 9891, Pages 507 - 515, 10 August 2013

Although the reduction in stroke was not significant, our results support that in patients with recent lacunar stroke, the use of a systolic-blood-pressure target of less than 130 mmHg is likely to be beneficial.