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Stroke, Vol 23, 3-8, Copyright © 1992 by American Heart Association
BACKGROUND AND PURPOSE: A randomized, double-blind, multicenter clinical
trial of placebo versus nimodipine was conducted to test the hypothesis
that nimodipine would reduce the frequency of death and of worsening by 30%
compared with placebo. METHODS: Nimodipine was used in doses of 60 mg, 120
mg, and 240 mg daily in 1,064 patients treated for 21 days. Treatment was
begun within 48 hours of stroke due to infarction as inferred by initial
computed tomographic scan findings. The Toronto and motor scales were
analyzed by analysis of covariance, using covariance-adjusted means, the
last-value-carried-forward, to compare the baseline value with the 3
assessment days (days 4, 10, and 21). RESULTS: No difference in mortality
or neurological outcome was found with any of the rating scales for the
overall cohort. Planned but post hoc subgroup analysis showed a reduction
in worsening frequency of 30% compared with placebo and significantly
better outcome scores with 120 mg nimodipine daily started within 18 hours
of stroke as measured by the Toronto scale (p less than 0.005) and when the
pretreatment computed tomographic scan was negative (p less than 0.003).
CONCLUSIONS: Nimodipine had no overall effect when treatment was begun
within 48 hours. Confirmation of the benefits suggested by post hoc
analyses for the subgroup treated with 120 mg nimodipine within 18 hours,
and who had negative computed tomographic scans, would require a separate
trial.
ARTICLES
Clinical trial of nimodipine in acute ischemic stroke. The American Nimodipine Study Group [published erratum appears in Stroke 1992 Apr;23(4):615]
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