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December 5, 2001

Ensuring Patient Safety in Clinical Trials for Treatment of Acute Stroke

Author Affiliations

Author Affiliations: Department of Neurology, University of Washington School of Medicine, Harborview Medical Center, Seattle.

JAMA. 2001;286(21):2718-2719. doi:10.1001/jama.286.21.2718

In this issue of THE JOURNAL, the Aptiganel Hydrochloride Acute Stroke Investigators1 present the results of yet another failed trial of neuroprotection for acute ischemic stroke. The continued negative results of such trials are disappointing, but studies such as this one also raise concerns. Compared with those who received placebo, patients who received aptiganel hydrochloride within 6 hours of stroke onset tended to experience increased morbidity and mortality. The independent data and safety monitoring board suspended the trial after the interim (phase 2) analyses of 300 patients were completed, but during the time needed for those analyses, 328 more patients were enrolled in the trial and exposed to the risks of the experimental drug.