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The role of intravenous recombinant tissue-type plasminogen activator (rt-PA) for the treatment of acute ischemic stroke is evolving. In this randomized, controlled study of 140 university and community hospitals in North America, 547 patients were randomized to receive 0.9 mg/kg of rt-PA (272 patients) or placebo (275 patients) intravenously for 1 hour; treatment began 3 to 5 hours after the onset of symptoms. Patients with intracerebral hemorrhage or evidence of very large territories of ischemia (more than a third of the territory of the middle cerebral artery) were excluded from the study.
Approximately equal percentages of rt-PA and placebo patients achieved the primary outcome of excellent neurologic function (a National Institutes of …