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Summary of the NINDS Trial
In patients presenting within 3 hours of ischemic stroke, alteplase improved 3-month neurological function (NNT=9) but did not impact 24-hour symptoms or mortality. In patients receiving alteplase, approximately one-quarter had minor bleeding, and 6.4% had symptomatic ICH (NNH=17).
Key Points from NINDS
- Included 624 patients presenting within 3 hours of ischemic stroke not meeting a long list of exclusion criteria, many related to risk of bleeding. There was no exclusion on the basis of severity of stroke or maximum age.
- Primary outcomes were split between two phases of the study. In phase I (n=291), the primary outcome was NIHSS improvement at 24 hours. In phase II (n=333), the primary outcome was a global assessment of four clinical outcome scales at 3 months
- Baseline NIHSS score was median of 14-15
At 24 hours (phase I), there was no difference in NIHSS improvement
- At 3 months (phase II), the odds ratio of a “favorable outcome” (global test) was 1.7 (95% CI 1.2-2.6), favoring TPA
- The NIHSS subgroup of the global test was improved compared to placebo (31% vs. 20%, p=0.0033, NNT=9)
- Symptomatic ICH occurred more frequently with TPA (6.4% vs. 0.6%, p<0.001, NNH=17)
- ICH was more common in patients with more severe stroke (NIHSS 20 vs. 14) or CT evidence of cerebral edema (9% vs. 4%)
- Minor bleeding was more common with TPA (23% vs. 3%, NNH 5)
- There was no difference in mortality
NINDS Investigators. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med. 1995 Dec 14;333(24):1581-7. PMID 7477192