NINDS t-PA Stroke Trial "NINDS-tPA"

Completed

Phase 3 Results

Summary of Purpose

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

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 27 May 2008.

Unavailable Unavailable Unavailable Unavailable Unavailable Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Basics

Interventions

Sponsors

  • National Institute for Neurological Disorders and Stroke, NIH

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.

Contacts

Not available