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Tissue plasminogen activator for acute ischemic stroke

One-paragraph summary

The two-part randomized double-blind NINDS trial enrolled 624 patients treated within three hours. Part 1 did not show the prespecified 24-hour neurological response, but Part 2 confirmed a favorable three-month global outcome across NIHSS, Barthel, Glasgow Outcome, and modified Rankin scales (global OR 1.7, 95% CI 1.2–2.6). Symptomatic ICH within 36 hours occurred in 6.4% with alteplase versus 0.6% with placebo; mortality was 17% versus 21% (P=0.30) (PMID 7477192).

Key findings

  • 291 participants in Part 1; 333 in Part 2.
  • Alteplase recipients were at least 30% more likely to have minimal or no disability at three months across the assessment scales.
  • Symptomatic ICH absolute excess was 5.8 percentage points.
  • Three-month mortality did not significantly differ.

Limitations

  • Treatment was restricted to three hours and required trial-level screening.
  • The primary framework used a global combination of four scales rather than today's conventional ordinal mRS analysis.
  • Modern imaging, thrombectomy, stroke systems, and background prevention were absent.

Why it matters

This trial established that an acute ischemic neurological deficit could be improved pharmacologically despite an immediate hemorrhage tradeoff, making treatment delay a central stroke-system target.

Cited by wiki pages

  • overview
  • acute ischemic stroke
  • clinical trials landscape