Neurology in critical care · Thrombolysis for ischaemic stroke
Tissue plasminogen activator for acute ischemic stroke
| Design | Two-part multicentre randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Intravenous t-PA within 3 hours of symptom onset |
| Control | Placebo |
| Population | 624 patients with acute ischaemic stroke |
| Follow-up | 3 months |
| Primary endpoint | Neurological improvement at 24 hours in part 1, and favourable outcome at 3 months in part 2 |
| Result | In part 1 there was no significant difference in neurological improvement at 24 hours, although benefit was apparent for the t-PA group later. Clinical outcome at three months was improved with t-PA despite an increased incidence of symptomatic intracerebral haemorrhage. |
| Secondary endpoints | Symptomatic intracerebral haemorrhage, mortality at 3 months |
Despite an increased incidence of symptomatic intracerebral hemorrhage, treatment with intravenous t-PA within three hours of the onset of ischemic stroke improved clinical outcome at three months.
The trial authors, in the published abstract
The trial that created acute stroke medicine and the three-hour window that organised stroke services for two decades. The trade it names — better function, more bleeding — has been the substance of every thrombolysis discussion since, and later trials (ECASS III, WAKE-UP, EXTEND) have pushed the window outward using imaging rather than the clock.
Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995 Dec 14;333(24):1581-7.