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Twenty-seven patients were randomized:20(10 recombinant tissue-type plasminogen activator,10 placebo)within 90 minutes,and 7(4 recombinant tissue-type plasminogen activator,3 placebo)from 91 to 180 minutes.Median baseline Stroke Scale scores were 16(minimum=5,maximum=26)for the recombinant tissue-type plasminogen activator-treated group and 11 (minimum=3,maximum=21)for the control subjects in the group treated within 90 minutes.Six patients treated with recombinant tissue-type plasminogen activator within 90 minutes improved by 4 or more points at 24 hours compared with 1 patient in the placebo group(P<.05),Fisher's Exact Test). Two patients in each group in the 91-to 180-minute arm improved.One fatal intracerebral hemorrhage occurred in the placebo group.A randomized, double-blind,placebo-controlled trial of recombinant tissue-type plasminogen activator very early in acute stroke is feasible.Preliminary observations suggest that recombinant tissue-type plasminogen activator treatment within 90 minutes may be associated with early neurological improvement.Larger studies are needed so that the potentially serious short-term risks of this treatment can be assessed in relation to meaningful long-term benefit. |
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