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Intra-arterial Prourokinase for Acute Ischemic Stroke

Paul T. Akins, MD, PhD
JAMA. 2000;283(16):2102-2104. doi:10.1001/jama.283.16.2101.
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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.

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