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April 26, 2000

Intra-arterial Prourokinase for Acute Ischemic Stroke—Reply

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor

JAMA. 2000;283(16):2102-2104. doi:10.1001/jama.283.16.2101

In Reply: We agree with Dr Akins that the only therapy approved by the FDA for acute ischemic stroke is IV tPA given within 3 hours of onset. However, PROACT II began in February 1996, 4 months before FDA approval of IV tPA. Following FDA approval, the PROACT investigators were ethically obliged to make eligible patients aware of IV tPA as part of the informed consent process. The PROACT investigators were also specifically advised they could treat eligible patients with IV tPA and, in fact, 180 patients were excluded from PROACT II on this basis.

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