Activase® is proven to reduce disability at 90 days in patients treated within 3 hours of symptom onset 6

The National Institute of Neurological Disorders and Stroke (NINDS) Trial was a large, randomized, placebo-controlled trial of intravenous Activase versus placebo in patients with acute ischemic stroke (AIS) treated within 3 hours of stroke symptom onset and was carried out in 2 parts. 6,14

  • Part 1 (n=291) assessed changes in neurologic deficits 24 hours after the onset of strokea
  • Part 2 (n=333) assessed whether treatment with Activase resulted in sustained clinical benefit at 3 monthsb

aComplete resolution of neurologic deficit or an improvement from baseline NIHSS score of 4 or more were defined as early improvement. 6 
bScores of 95 or greater on the Barthel index, ≤1 on the NIHSS and the modified Rankin Scale, and 1 on the Glasgow Outcome Scale were considered to indicate a favorable outcome. 6

Trial Design



GWTG=Get With The Guidelines


  • The NINDS Trial showed that Activase given within 3 hours of symptom onset of AIS reduced the incidence of disability among treated patients compared with placebo at 3 months. 6

See data from the pivotal trial and real-world, retrospective analysis from the Get With The Guidelines-Stroke registry.