Neurology in critical care · Thrombolysis beyond the clock
Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke
| Design | Phase 3 multicentre randomised trial, terminated early for loss of equipoise |
|---|---|
| Treatment | Intravenous alteplase 4.5 to 9 hours after onset, or on waking, guided by perfusion imaging |
| Control | Placebo |
| Population | 225 of a planned 310 patients with ischaemic stroke and salvageable brain tissue on perfusion imaging |
| Follow-up | 90 days |
| Primary endpoint | Modified Rankin Scale score of 0 to 1 at 90 days |
| Result | 113 patients were randomly assigned to alteplase. Use of alteplase between 4.5 and 9 hours after onset or on waking resulted in a higher proportion with no or minor neurological deficit than placebo. The trial was terminated after publication of positive results from a previous trial removed equipoise. |
| Secondary endpoints | Modified Rankin shift, reperfusion, symptomatic intracerebral haemorrhage |
Among the patients in this trial who had ischemic stroke and salvageable brain tissue, the use of alteplase between 4.5 and 9.0 hours after stroke onset or at the time the patient awoke with stroke symptoms resulted in a higher percentage of patients with no or minor neurologic deficits than the use of placebo.
The trial authors, in the published abstract
Pushes the imaging-selected window to nine hours, complementing WAKE-UP. Stopped early for loss of equipoise, so the estimate is imprecise. Together these trials moved stroke thrombolysis from a stopwatch problem to a tissue-viability problem.
Ma H, Campbell BCV, Parsons MW, et al. Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke. N Engl J Med 2019 May 9;380(19):1795-1803.