| Methods |
Single centre, double‐blind, placebo‐controlled
Method of randomisation unknown
ITT analysis |
| Participants |
Italy
41 patients: T: 19, C: 22
Mean age: T: 62 years, C: 63 years
Males: T: 11, C: 17
Inclusion: patients with sudden and persistent neurological deterioration due to a focal event in the carotid artery distribution
100% CT
Enrolment within 12 hours |
| Interventions |
T: nimodipine 40 mg tds
C: identical matching placebo
Rx: 28 days
Patients given supportive medication of 20% mannitol, antihypertensive agents and antibiotics |
| Outcomes |
Neurological deficit (Mathews slightly modified by Gelmers) baseline and at days 1, 2, 3, 5, 7, 14, 21, 28
Global assessment made at end of treatment ‐ good/fair/poor
BP and heart rate recorded twice daily, method of recording not given |
| Notes |
Ex: TIA, progressing stroke, primary intracerebral haemorrhage (CT scan), systemic disorders, recent MI, CCF, abnormal hepatic, renal or pulmonary functions, previous history of complete stroke
Data from published paper |
| 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 |
High risk |
Probably not complete
41 entered the study (T: 19, C: 22) and at the end of period of observation 18 nimodipine‐treated patients with 1 possible loss of follow up |
