Methods |
Multicentre, double‐blind, placebo‐controlled
Randomisation by secure Internet central randomisation (with block size of 6)
ITT analysis |
Participants |
UK
172 patients: T: 56, C: 29
Mean age: 74 years
Male 57%
Inclusion: > 18 years of age, fixed neurological deficit > 60 minutes, clinical diagnosis of acute stroke
Enrolment within 36 hours of ictus |
Interventions |
Lisinopril or matching placebo was initially given at 5 mg po with an opportunity to repeat the dose at 4 hours and 8 hours after randomisation, with participants then continued on 5 to 15 mg of lisinopril once daily for up to 2 weeks |
Outcomes |
Death or dependency at 2 weeks
Supine BP was measured with a validated A&D UA‐767 BP monitor with a cuff of a suitable size |
Notes |
Ex: hypertensive encephalopathy, co‐existing cardiac or vascular emergency, SBP > 200 mmHg and/or DBP > 120 mmHg in association with primary intracerebral haemorrhage, pre‐existing antihypertensive therapy in patients without dysphagia, impaired level of consciousness, contraindication to trial therapy, premorbid mRS > 3, coexisting life threatening condition with life expectancy < 6 months, diagnosis of non‐stroke on subsequent neuroimaging |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Randomly assigned by secure Internet central randomisation (with a block size of 6) |
Allocation concealment? |
Low risk |
Probably done |
Blinding? |
Low risk |
Probably done |
Completeness of follow‐up |
High risk |
179 patients randomly assigned, 6 withdrawn due to a protocol violation or non‐stroke diagnosis and 1 withdrew consent |