The Efficacy of Nitric Oxide in Stroke (ENOS) Trial
- Conditions
- StrokeTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2004-003870-27-GR
- Lead Sponsor
- niversity of Nottingham, ResearchHead of research grants and contractsInnovation Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4011
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
recruited]
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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the balance of risk and benefit of lowering blood pressure with GTN immediately after ischaemic and haemorrhagic stroke.;Secondary Objective: Assess whether pre-stroke antihypertensive therapy should be continued or stopped temporarily after stroke.<br>;Primary end point(s): Combined death or dependency (modified Rankin Score >2);Timepoint(s) of evaluation of this end point: 90 days after stroke onset
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -----;Timepoint(s) of evaluation of this end point: -----