Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor
Copyright 2000 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2000
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.
Furlan A, Wechsler L, Gent M, Higashida R, Roberts R. Intra-arterial Prourokinase for Acute Ischemic Stroke—Reply. JAMA. 2000;283(16):2102-2104. doi:10.1001/jama.283.16.2101