Randomised, double-blind, placebo-controlled trial of nimodipine in acute stroke. Trust Study Group

Abstract

The value of oral nimodipine 120 mg per day for acute stroke was assessed in a randomised, double-blind, placebo-controlled multicentre study of 1215 patients. The primary end-point was independence after 6 months, defined as a score of 60 or more on an activities of daily living (ADL) scale, the Barthel index. Patients were entered into the trial if they were aged over 40, became hemiparetic in the previous 48 h, were conscious, were able to swallow, and had been living independently before the stroke. At 6 months, 55% of the nimodipine group and 58% of the placebo group were independent, the odds ratio for independence on nimodipine being 0.88 (95% confidence limits 0.70-1.10). For mortality the odds ratio with nimodipine was 1.22 (95% confidence limits 0.95-1.57). ADL and neurological scores also suggested delayed recovery in the nimodipine group at 3 weeks. The results do not support the case for oral nimodipine therapy 120 mg per day starting within 48 h of the stroke, for patients with acute stroke.