NINDS t-PA Stroke Trial "NINDS-tPA"

Completed

Phase 3 Results

Trial Description

To test the potential benefit of t-PA when administered within 3 hours of stroke onset.

Interventions

Trial Design

Randomized, double-blind trial. The trial had two parts. Part 1 (in which 291 patients were enrolled) tested whether t-PA had clinical activity, as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale (NIHSS) or the resolution of the neurologic deficit within 24 hours of the onset of stroke. Part 2 (in which 333 patients were enrolled) used a global test statistic to assess clinical outcome at three months, according to scores on the Barthel index, modified Rankin scale, Glasgow outcome scale, and NIHSS.

Patient Involvement

Patients were randomized to receive t-PA or placebo and were assessed at either 24 hours or 3 months after stroke onset.

Outcomes

Type Measure Time Frame Safety Issue
Primary Part 1: clinical activity, as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale (NIHSS) or the resolution of the neurologic deficit within 24 hours of the onset of stroke. Part 2: Barthel index, modified Rankin scale, Glasgow outcome scale, and NIHSS.

Sponsors

National Institute for Neurological Disorders and Stroke, NIH