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To the Editor: The Prolyse in Acute Cerebral Thromboembolism II (PROACT II) investigators¹ reported a benefit of intra-arterial prourokinase compared with placebo for treating patients with acute occlusions of the middle cerebral artery. I am concerned about the appropriateness of the placebo control group for this study. Clinical trial design must compare any proposed therapies with the best available medical treatment. For patients presenting within 3 hours of ischemic stroke onset, the Food and Drug Administration (FDA) has approved intravenous (IV) tissue-type plasminogen activator (tPA). However, because of the study design, some subjects in the placebo group may have been denied this treatment.

The PROACT II trial enrolled patients within the first 6 hours of stroke onset. The authors do not state how screening and enrollment were managed for patients presenting at these centers within 3 hours of onset. A median time for enrollment was provided but the range was . . . [Full Text of this Article]

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Intra-arterial Prourokinase for Acute Ischemic Stroke: The PROACT II Study: A Randomized Controlled Trial
Anthony Furlan, Randall Higashida, Lawrence Wechsler, Michael Gent, Howard Rowley, Carlos Kase, Michael Pessin, Arvind Ahuja, Fred Callahan, Wayne M. Clark, Frank Silver, Frank Rivera, and for the PROACT Investigators
JAMA. 1999;282(21):2003-2011.
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