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 (ISRCTN99414122)

被引：91

作者：

Thomas, D. ^{[1
]}

Bath, P. M. ^{[1
]}

Lees, K. ^{[1
]}

Hextall, E. J. ^{[1
]}

Skene, A. ^{[1
]}

Pocock, S. ^{[1
]}

Wardlaw, J. M. ^{[1
]}

Whynes, D. ^{[1
]}

Bath, P. M. ^{[1
]}

Bladin, C. ^{[1
]}

Chen, C. L. ^{[1
]}

Caso, V. ^{[1
]}

Desfontaines, P. ^{[1
]}

Czlonkowska, A. ^{[1
]}

Gommans, J. ^{[1
]}

Lees, K. R. ^{[1
]}

Navarro, L. C. ^{[1
]}

Phillips, S. J. ^{[1
]}

Sandercock, P. A. G. ^{[1
]}

Asplund, K. ^{[1
]}

Baigent, C. ^{[1
]}

Bereczki, D. ^{[1
]}

Wardlaw, J. M. ^{[1
]}

Dineen, R. ^{[1
]}

Weaver, C. ^{[1
]}

Ferentzi, U. ^{[1
]}

Stear, H. ^{[1
]}

Hammonds, F. ^{[1
]}

Rashid, P. ^{[1
]}

Willmot, M. ^{[1
]}

Sprigg, N. ^{[1
]}

Whysall, B. ^{[1
]}

Kant, L. ^{[1
]}

Leonardi-Bee, J. ^{[1
]}

Gray, L. ^{[1
]}

Clarke, W. ^{[1
]}

机构：

[1] Univ Nottingham, Div Stroke Med, Queens Med Ctr, Nottingham NG7 2UH, England

来源：

INTERNATIONAL JOURNAL OF STROKE | 2006年 / 1卷 / 04期

基金：

英国医学研究理事会;

关键词：

acute stroke; antihypertensive therapy; cerebrovascular disorders; glyceryl trinitrate; randomised-controlled trial;

D O I：

10.1111/j.1747-4949.2006.00059.x

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

High blood pressure (BP) is common in acute stroke and is independently associated with a poor outcome. Many patients with acute stroke are taking anti hypertensive 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.

引用

页码：245 / 249

页数：5

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