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Kyra J. Becker, MD; David L. Tirschwell, MD,MSc

JAMA. 2001;286:2718-2719.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

The possibility of harm during a randomized trial of an experimental drug must be assessed with caution.² Early trends of rare adverse events can appear clinically and statistically . . . [Full Text of this Article]

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

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