Methods |
Multicentre, double‐blind, placebo‐controlled
Randomisation used sealed envelopes, stratified by onset of therapy, age and stroke severity
Tablets provided in identical numbered vials
ITT analysis |
Participants |
Finland, 3 centres
350 patients: T: 176, C: 174
Mean age: T: 57 years, C: 58 years
Males: T: 122, C: 113
Inclusion: acute ischaemic hemispheric stroke
100% CT
Enrolment within 48 hours |
Interventions |
T: 30 mg nimodipine qid
C: matching placebo
Rx: 21 days |
Outcomes |
Neurological evaluation (own score) at baseline, day 1, 7, 21 and months 3 and 12; mobility at 12 months
Functional outcome, Rankin at 3 and 12 months ‐ grades 1 and 2 representing independence were considered good outcome
Primary end points: Rankin at 12 months, neurological scale and death
Used Rankin > 3 for dependence in this review
Rankin scale missing 2 living patients in control and 1 living patient in treatment group
Method of BP measurement unknown |
Notes |
Ex: unconsciousness, dysphagia, TIA, dependence in ADL before stroke, brain stem infarction, complicated migraine, pregnancy, renal or hepatic or cardiac failure, severe systemic infection, serious psychiatric disturbance, terminal malignancy
Data from published paper and author |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Randomisation used sealed envelopes, stratified by onset of therapy, age and stroke severity |
Allocation concealment? |
Low risk |
Probably done |
Blinding? |
Low risk |
Probably done |
Completeness of follow‐up |
Unclear risk |
Unclear from the publication |