ENOS-2
Research type
Research Study
Full title
Efficacy of Nitric Oxide in Stroke -2
IRAS ID
281728
Contact name
Philip Bath
Contact email
Sponsor organisation
University of Nottingham
Eudract number
2020-001304-42
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
High blood pressure (BP) is common in patients with very recent stroke and causes increased disability and death. But how best to look after patients remains unclear although guidelines recommend lowering very high BP in brain bleeds. We have evidence that lowering BP with glyceryl trinitrate (GTN, £0.50/day) given as an angina skin patch has variable effects on outcome depending on timing: it may be detrimental if given very early after stroke within 2 hours, may be beneficial if early between 2-6 hours, and has no effect when given beyond 6 hours. We hope to run a pilot trial of BP lowering in the middle time period. 100 consenting participants with a stroke of blood clot type will receive a GTN or dummy patch given at random (toss of a coin) 3 to 5 hours after stroke, with a second patch the next morning. We will assess the feasibility of recruiting in this delayed and narrow time-window, and the effect of GTN on BP and disability and death at 90 days. If it is feasible to recruit in this narrow time-window of 3-5 hours and the trial supports earlier results then we will seek funding for a larger definitive trial.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0246
Date of REC Opinion
30 Jun 2020
REC opinion
Further Information Favourable Opinion