Aspirin-clopidogrel no better than aspirin alone for patients with Lacunar Stroke

Aspirin combined with the antiplatelet drug clopidogrel is no better than aspirin alone for stroke prevention in people with a history of lacunar strokes, and the combination carries a greater risk of gastrointestinal bleeding, according to results of a trial funded by the National Institutes of Health. Lacunar strokes occur due to chronic high blood pressure and typically produce small lesions deep within the brain.

The Secondary Prevention of Small Subcortical Strokes (SPS3) trial was designed to determine if adding clopidogrel to aspirin would offer better protection than aspirin alone. The trial involves more than 3,000 participants at 82 clinical centers in North and South America and in Spain. The participants are age 30 and older, and all had a recent history of lacunar stroke prior to enrollment. About 52 percent are white, 31 percent Hispanic and 17 percent black. In addition to comparing dual antiplatelet therapy with aspirin, the trial was designed to test two levels of blood pressure control.

After an interim data analysis in August 2011, the antiplatelet component of the trial was stopped. NIH also issued a clinical alert warning that there was "little likelihood of benefit in favor of aspirin plus clopidogrel [for] recurrent stroke should the study continue to conclusion." The blood pressure component of the trial is ongoing, and the trial participants have been encouraged to continue taking aspirin without clopidogrel.

See: "Effects of clopidogrel added to aspirin in patients with recent lacunar stroke." Benavente et al. for the SPS3 investigators. New England Journal of Medicine, August 30, 2012. DOI: 10.1056/NEJMoa1204133.