EUCTR2004-003870-27-SE进行中（未招募）1 期
The Efficacy of Nitric Oxide in Stroke (ENOS) Trial: A prospective, collaborative, international, multicentre, randomised, parallel-group, single and outcome blinded, controlled, factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of continuing or stopping temporarily pre-stroke antihypertensive therapy, in patients with acute stroke - ENOS
niversity of Nottingham0 个研究点目标入组 4,011 人开始时间: 2011年11月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,011
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a) Adult (age > 18 years).
- •b) Clinical stroke syndrome with limb weakness lasting at least 1 hour (i.e. not likely to be a
- •transient ischaemic attack).
- •c) Residual limb weakness at the time of enrolment (SSS Arm <6 and/or Leg <6, appendix C).
- •d) Onset < 48 hours. If the time of onset is unknown, apply the time when the patient was last
- •known to be well. [This timeframe covers the period of maximum uncertainty over altering
- •blood pressure and should permit the vast majority of otherwise eligible patients to be
- •e) Conscious (Glasgow Coma Scale > 8).
- •f) Systolic blood pressure in range 140 mmHg to 220 mmHg inclusive on the basis of at least
- •one of the three baseline pre-randomisation measures.
- •g) Independent prior to stroke (pre-morbid modified Rankin Scale < 2).
- •h) Meaningful consent, or assent from a relative or carer if the patient is unable to give
- •meaningful consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3200
排除标准
- •a) Definite need for nitrate therapy: e.g. concurrent myocardial infarction, unstable angina, left
- •ventricular failure. Patients admitted on nitrates for the management of stable angina may
- •stop these for the 7 day trial treatment period. b) Contraindication to nitrate therapy: e.g. hypersensitivity to nitrates, dehydration,
- •hypovolaemia, hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac
- •tamponade, constrictive pericarditis, mitral stenosis, marked anaemia, closed-angle
- •glaucoma, sildenafil (Viagra) or related drug, within 24 hours.
- •c) Definite need for pre-stroke antihypertensive, anti-anginal or anti-heart failure medication:
- •e.g. concurrent angina, heart failure.
- •d) Definite need for new antihypertensive, anti-anginal or anti-heart failure medication during
- •acute stroke: e.g. concurrent angina, heart failure, hypertensive encephalopathy, aortic
- •dissection.
- •e) Patients expected, on the basis of existing investigations, to require surgical intervention
- •(e.g. clot evacuation, carotid endarterectomy) during the treatment or follow-up period.
- •f) Known intracerebral pathology other than stroke, e.g. subarachnoid haemorrhage, brain
- •tumour, cerebral abscess.
- •g) Other serious condition which is likely to prevent outcome assessment at 90 days, e.g.
- •advanced cancer.
- •h) Previous enrolment in ENOS.
- •i) Current involvement in another trial of an experimental drug. [Patients may be randomised
- •into observational studies or non-drug trials.]
- •j) Not available for follow-up, e.g. no fixed address, overseas visitor.
- •k) Females of childbearing potential where pregnancy cannot be excluded by a negative
- •pregnancy test, pregnancy, or breastfeeding.
- •l) Need for new antihypertensive therapy to lower systolic blood pressure to achieve the
- •enrolment range of 140-220mmHg
- •m) New (not prescribed pre-stroke) antihypertensive medication commenced after stroke onset
研究者
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