| Methods |
Open label blinded‐endpoint
Dose comparison
Controlled trial
Randomisation by computer (with minimisation on age, gender, Scandinavian Neurological Stroke Scale and mean arterial pressure)
FU: no losses
ITT analysis |
| Participants |
UK, single centre
90 patients: T: 60, C: 30
Mean age: T: 70.8 years, C: 73.9 years
Male: T: 28, C: 13
Inclusion: ischaemic or haemorrhagic stroke
Enrolment within 72 hours of ictus
Clinical stroke subtype at baseline and CT scanning within a week of stroke onset
Any antihypertensive medication was stopped at the time of admission and recommenced after 10 days once the trial treatment phase was completed |
| Interventions |
Transdermal glyceryl trinitrate once daily: T1: 5 mg , T2: 5/10 mg, T3: 10 mg
C: no patch
Rx: 10 days |
| Outcomes |
24 hour ambulatory BP monitoring was set to record 3 times per hour during the day and hourly during the night at days 0, 1, 4, 5 and 10
mRS, Barthel index and quality of life at 3 months |
| Notes |
Ex: SBP > 230 mmHg or < 100 mmHg, DBP > 130 mmHg or < 60 mmHg, heart rate > 130 beats/minute or < 50 beats/minute, mild stroke, coma, pre‐morbid dependence, or presence of illnesses that could confound neurological or functional evaluation (such as pre‐existing neurologic or psychiatric disorders) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Randomisation by computer (with minimisation on age, gender, Scandinavian Neurological Stroke Scale and mean arterial pressure) |
| Allocation concealment? |
Low risk |
Probably done |
| Blinding? |
High risk |
Probably not done |
| Completeness of follow‐up |
Low risk |
No loss of follow up |
