A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF NIMODIPINE INACUTE ISCHEMIC HEMISPHERIC STROKE

Background and Purpose A randomized, double-blind, placebo-controlled multicenter trial was conducted to test the hypothesis that nimodipine would improve the functional outcome in acute ischemic hemispheric st roke. Methods A total of 350 patients were randomized to nimodipine 12 0 mg/d PO or matching placebo for 21 days. Randomization was stratifie d by onset of therapy, age, and stroke severity. Treatment was begun w ithin 48 hours of onset. The patients had neurological evaluation on a dmission, on days 1, 7, and 21, and at 3 and 12 months. The primary en d points were Rankin grade, neurological score, and mobility at 12 mon ths. Results We did not find any differences in the functional outcome between the treatment groups or between the stratified subgroups. We were also unable in post hoc analyses to find any groups of patients w ho benefited from nimodipine. During the first month and at 3 months t he case-fatality rate was higher in the nimodipine-treated patients th an in those on placebo (P=.004 and P=.030, respectively), but at the 1 -year follow-up this difference had lost statistical significance. Dur ing the first week nimodipine had a statistically significant lowering effect on both systolic (P=.005) and diastolic (P=.013) blood pressur e. Conclusions Nimodipine did not improve the functional outcome of ac ute ischemic hemispheric stroke. The early case-fatality rate was high er in the nimodipine group, possibly due to the blood pressure-lowerin g effect of nimodipine.