Thomas, D. et al. (2006) Glyceryl trinitrate vs. control, and continuing vs. stopping temporarily prior anti hypertensive therapy, in acute stroke: rationale and design of the Efficacy of Nitric Oxide in Stroke (ENOS) trial. International Journal of Stroke, 1(4), pp. 245-249. (doi: 10.1111/j.1747-4949.2006.00059.x)
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Publisher's URL: http://dx.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.
Item Type: | Articles |
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Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Lees, Professor Kennedy |
Authors: | Thomas, D., Bath, P.M., Lees, K.R., Hextall, F.J., Skene, A., Pocock, S., Wardlaw, J.M., Whynes, D., Bladin, C., Chen, C.L., Caso, V., Desfontaines, P., Czlonkowska, A., Gommans, J., Navarro, J.C., Phillips, S.J., Wang, Y.J., Wong, L., Sandercock, P.A.G., Asplund, K., Baigent, C., Bereczki, D., Dineen, R., Weaver, C., Ferentzi, U., Stear, H., Hammonds, F., Rashid, P., Willmot, M., Sprigg, N., Whysall, B., Kaur, L., Leonardi-Bee, J., Gray, L., and Clarke, W. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | International Journal of Stroke |
ISSN: | 1747-4930 |
ISSN (Online): | 1747-4949 |
Published Online: | 10 October 2006 |
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