Neurology in critical care · Thrombolysis for ischaemic stroke
Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke
| Design | Phase 3 multicentre randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Intravenous alteplase 3 to 4.5 hours after onset |
| Control | Placebo |
| Population | 821 patients with acute ischaemic stroke; median time to alteplase 3 hours 59 minutes |
| Follow-up | 90 days |
| Primary endpoint | Disability at 90 days, dichotomised on the modified Rankin Scale |
| Result | More patients had a favourable outcome with alteplase than placebo among the 418 and 403 patients respectively. Symptomatic intracranial haemorrhage was more frequent with alteplase. |
| Secondary endpoints | Global outcome measure, mortality, symptomatic intracranial haemorrhage |
As compared with placebo, intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke; alteplase was more frequently associated with symptomatic intracranial hemorrhage.
The trial authors, in the published abstract
Extended the NINDS t-PA window by ninety minutes and reorganised stroke pathways accordingly. The benefit is smaller than within three hours, which is why 'time is brain' survived the extension rather than being retired by it.
Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008 Sep 25;359(13):1317-29.