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| [ ...Back to search results ] | [ Print-friendly version ] |
| Efficacy of Nitric Oxide in Stroke |
| Source of record | UK Trials |
| ISRCTN | ISRCTN99414122 |
| Date ISRCTN assigned | 12/11/2002 |
| Local reference number(s) | N/A |
| Public title | Efficacy of Nitric Oxide in Stroke |
| Scientific title | |
| Acronym | ENOS |
| Disease/condition/study domain | Acute stroke |
| Study hypothesis | Three-quarters of patients are hypertensive at the presentation of acute stroke while a high blood pressure is independently associated with a poor outcome. No large trials have specifically assessed whether blood pressure should be actively altered during the acute phase of stroke although outcome was worse in some trials of calcium channel blockers and beta receptor antagonists, probably through negative effects on cerebral blood perfusion and cardiac outout. However, small studies involving drugs from other antihypertensive classes, including nitric oxide donors, suggest they may reduce blood pressure without reducing cerebral blood flow. Similarly, no studies have assessed whether prior anti-hypertensive medication should be stopped or continued. A definitive trial is now required to: 1. Assess the balance of risk and benefit of lowering blood pressure immediately after ischaemic and haemorrhagic stroke. 2. Assess whether prior antihypertensive therapy should be continued or stopped temporarily after stroke. |
| Design/methodology | Prospective, international, multicentre, randomised, parallel-group, double-blind, placebo-controlled |
| Research ethics review | Not provided at time of registration |
| Countries of trial | Australia, Belgium, Canada, China, Hong Kong, Italy, New Zealand, Philippines, Poland, Singapore, United Kingdom |
| Participants - inclusion criteria | 5000 patients with acute ischaemic or haemorrhagic stroke within 48 hours, systolic blood pressure 140-220 mmHg |
| Participants - exclusion criteria | 1. Unconscious (Glasgow Coma Scale less than eight) 2. Definite need for nitrate therapy: concurrent myocardial infarction, unstable angina, left ventricular failure 3. Dehydration 4. Contraindication to nitrate therapy: hypersensitivity to nitrates, hypovolaemia, hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac tamponade, constrictive pericarditis, mitral stenosis, marked anaemia, closed-angle glaucoma, sildenafil (Viagra) within previous 24 hours 5. Systolic blood pressure less than 140 mmHg or more than 220 mmHg 6. Patients expected to require surgical intervention (e.g. clot evacuation, carotid endarterectomy) during the treatment or follow-up period 7. Refusal to consent 8. Patient dependent on others prior to stroke (e.g. Rankin score more than three) 9. Known intracerebral pathology other than ischaemic stroke, e.g. subarachnoid haemorrhage, brain tumour, cerebral abscess 10. Other serious condition which is likely to prevent outcome assessment, e.g. advanced cancer 11. Involvement in a trial of another experimental intervention (drug or surgery) for acute stroke 12. Not available for follow-up, e.g. no fixed address, overseas visitor 13. Females of childbearing potential, pregnancy or breastfeeding |
| Patient information material | |
| Anticipated start date | 01/01/2004 |
| Anticipated end date | 31/10/2011 |
| Status of trial | Ongoing |
| Target number of participants | 5000 |
| Interventions | 1. Glyceryl trinitrate (transdermal) 2. Continue/temporarily stop prior anti-hypertensive therapy |
| Primary outcome measure(s) | Death and dependency (Rankin score more than two). |
| Secondary outcome measure(s) | 1. Events by seven days - recurrent stroke, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, blood pressure daily between one and seven days 2. Hospital events - length of stay in hospital, discharge disposition (death, institution, or home) 3. Outcome at three months - Barthel Index (less than 60, including death), Barthel Index more than 95/100 at three months (good outcome), quality of life (EuroQol), abbreviated mental test score 4. Safety measures - death at seven days and three months, symptomatic intracranial haemorrhage at seven days, major extracranial haemorrhage at ten days |
| Trial website | http://www.enos.ac.uk/ |
| Publications | Protocol available: The ENOS Trial Investigators. 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 J Stroke 2006;1:245-249. |
| Sources of funding | 1. UK Medical Research Council: from 1 November 2006 2. Singapore A*STAR (MRI sub-study) 3. UK BUPA Foundation: 1 April 2004 - 31 October 2006 4. UK Medical Research Council (as part of NeuroGRID) 5. UK Hypertension Trust: 1 September 02 - 31 August 2004 6. UK Reichstadt bequest 7. UK Stroke Association 8. UK University of Nottingham (through Information Services) |
| Sponsor name | University of Nottingham (UK) |
| Sponsor details | University Park Nottingham United Kingdom NG7 2RD |
| Sponsor website | http://www.nottingham.ac.uk/stroke-medicine/ |
| Contact name | Prof Philip Bath |
| Contact details | Division of Stroke Medicine University of Nottingham City Hospital Campus Nottingham United Kingdom NG5 1PB |
| Contact telephone | +44 (0)115 823 1768 |
| Contact fax | +44 (0)115 823 1771 |
| Contact email | philip.bath@nottingham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99414122 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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