Which agent is FDA approved for thrombolytic therapy of acute ischemic stroke (AIS)?

Updated: Aug 04, 2021
  • Author: Wanda L Rivera-Bou, MD, FAAEM, FACEP; Chief Editor: Erik D Schraga, MD  more...
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The US Food and Drug Administration (FDA) approved the use of IV tissue plasminogen activator (tPA) in 1996, partly on the basis of the results of the National Institute of Neurological Disorders and Stroke (NINDS) trial of IV recombinant tPA (rtPA). Favorable outcomes were achieved in 31-50% of patients treated with rtPA and 20-38% of patients given placebo; the major risk of treatment was symptomatic intracranial hemorrhage (sICH), which occurred in 6.4% of patients treated with rtPA and in 0.6% of patients given placebo. [44]

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