The National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator Stroke Study.
624 patients with iscahemic stroke were treated with 0.9 mg/kg (max 90 mg) rt-PA within 3 hours after the onset of symptoms. Half of the patients received treatment within 90 minutes.
Of the rt-PA treated patients 31-50% had complete or near-complete recovery at 3 months compared with 20-38% given placebo. This benefit was similar at 1 year.
The main hazard was of symptomatic cerebral haemorrhage in 6.4% of the treatment group compared with 0.6% in the placebo group. Indiviuduals with a more severe intial neurological defect or mass effect on the baseline CT scan were at greater risk of this complication.
Mortality was similar in both groups rt-PA vs placebo, at 3 months 17% vs 20%, at 1 year 24% vs 28%.
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