Methods |
Multicentre, placebo‐controlled
Method of randomisation not given
PP analysis
41 patients excluded blindly from efficacy analysis |
Participants |
Spain, 4 centres
164 patients: T: 81, C: 83
Age range: 45 to 92 years
Males: T:43, C:43
Inclusion: IS in internal carotid artery territory as by clinical examination
100% CT within 3 days
Enrolment within 48 hours |
Interventions |
T: 30 mg qid nimodipine po
C: identical placebo
Rx: 28 days
Allowed drugs included heparin (5000 IU bid) and agents indicated for cerebral oedema and cardiovascular drugs (not CCBs) and antibiotic or anxiolytic drugs |
Outcomes |
Slightly modified Mathews scale by Gelmers et al at baseline, 1, 3, 5, 7, 14, 21, 28 days
BP data obtained from paper, using PP numbers
Death data taken from paper using ITT data
BP estimated from graphs in paper |
Notes |
Ex: MI, renal failure, liver failure, severe systemic infections, poorly controlled DM, SBP < 100 mmHg, terminal malignancy, TIA, evolving strokes, coma |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Probably done |
Allocation concealment? |
Unclear risk |
Unclear from the publication |
Blinding? |
Low risk |
Probably done |
Completeness of follow‐up |
Unclear risk |
Unclear from the publication |