*ENOS investigators: Trial Steering Committee: D. Thomas (Independent Chairman), P. M. Bath (Chief Investigator), K. Lees (Stroke Trialist), F. J. Hextall (Scientist, to 2002), A. Skene (Statistician, to 2003), S. Pocock (Statistician, from 2003), J. M. Wardlaw (from 2006), and D. Whynes (from 2006). International Advisory Committee: P. M. Bath (Chairman), C. Bladin (Australia), C. L. Chen (Singapore), V. Caso (Italy), P. Desfontaines (Belgium), A. Czlonkowska (Poland), J. Gommans (New Zealand), K. R. Lees (United Kingdom), J. C. Navarro (Philippines), S. J. Phillips (Canada), Y. J. Wang (China), and L. Wong (Hong Kong). Data-Monitoring Committee: P. A. G. Sandercock (Chairman, UK), K. Asplund (Sweden), and C. Baigent (United Kingdom). Adjudication: Serious Adverse Events: D. Bereczki (Hungary); Neuroimaging: J. M. Wardlaw (Chairman, UK), and R. Dineen (UK). Trial Management Committee (Nottingham, UK): Nurse coordinators: C. Weaver (2001–2004), U. Ferentzi (2004–2005), H. Stear (2005–2006), and F. Hammonds (from 2005); Medical coordinators: P. Rashid (2001–2003), M. Willmot (2002–2004), and N. Sprigg (2003–2006); Outcome coordinators: B. Whysall (2001–2004) and L. Kaur (from 2005); Statisticians: J. Leonardi-Bee (2001–2003) and L. Gray (from 2003); Finance: W. Clarke (from 2001).
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)
Version of Record online: 10 OCT 2006
International Journal of Stroke
Volume 1, Issue 4, pages 245–249, November 2006
How to Cite
The ENOS Trial Investigators (2006), 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). International Journal of Stroke, 1: 245–249. doi: 10.1111/j.1747-4949.2006.00059.x
- Issue online: 10 OCT 2006
- Version of Record online: 10 OCT 2006
- Acute Stroke;
- Antihypertensive Therapy;
- Cerebrovascular Disorders;
- Glyceryl Trinitrate;
- Randomised-Controlled Trial
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.