Glyceryl Trinitrate vs. Control, and Continuing vs. Stopping Temporarily Prior Antihypertensive Therapy, in Acute Stroke: Rationale and Design of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial (ISRCTN99414122)
- 1 November 2006
- journal article
- research article
- Published by SAGE Publications in International Journal of Stroke
- Vol. 1 (4), 245-249
- https://doi.org/10.1111/j.1747-4949.2006.00059.x
Abstract
High blood pressure (BP) is common in acute stroke and is independently associated with a poor outcome. Many patients with acute stroke are taking antihypertensive medications. To test the safety and efficacy of 7 days of transdermal glyceryl trinitrate (GTN, 5 mg/day) vs. no GTN in patients with acute stroke; patients taking antihypertensive therapy immediately before their stroke are also randomised to continue vs. stop this temporarily. ENOS is a prospective international multicentre single-blind randomised-controlled trial in 5000 patients with acute (< 48 h of onset) ischaemic or haemorrhagic stroke. The primary outcome is combined death and dependency (modified Rankin scale > 2) at 90 days measured by blinded central telephone follow-up. Secondary outcomes include: BP over the 7 days of treatment; death, impairment (Scandinavian stroke scale), recurrence, and neuroimaging at 7 days; discharge disposition, disability (Barthel index), cognition (mini-mental status examination) and quality of life (EuroQoL). The sample size will allow an absolute difference in death/dependency of 5% to be detected with 90% power at 5% significance for GTN versus no GTN. Randomisation and data collection are performed over a secure Internet site with real-time data validation. Neuroimaging and serious adverse events are adjudicated blinded to treatment.Keywords
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