Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
3500 participants
INTERVENTIONAL
2001-07-31
2013-10-31
Brief Summary
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1. The safety and efficacy of nitric oxide, given as transdermal glyceryl trinitrate.
2. The safety and efficacy of stopping or continuing prior antihypertensive medication.
Previously independent adult patients who are conscious and have residual limb weakness are eligible for enrollment. Central randomisation will be performed via the internet. Treatment is initiated within 48 hours of stroke onset and is given as daily glyceryl trinitrate patches for 7 days. A computed tomography (CT) scan is required within 7 days of randomisation. Early follow-up is performed locally over the 7 days of treatment, including blood pressure, early stroke events, and adverse events. Telephone central follow-up by the trial co-ordinating centre will be performed at 3 months. The primary outcome is combined death or dependency (modified Rankin Score \>2).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Glyceryl trinitrate transdermal patch
Transdermal glyceryl trinitrate patch
5mg per day
Continue or stop pre-stroke antihypertensives
Pre-stroke antihypertensives
Continue or stop pre-stroke anti-hypertensives
Interventions
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Transdermal glyceryl trinitrate patch
5mg per day
Pre-stroke antihypertensives
Continue or stop pre-stroke anti-hypertensives
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical stroke syndrome with limb weakness lasting at least 1 hour i.e. not likely to be a transient ischaemic attack).
* Limb weakness (SNSS Arm \<6 and/or Leg \<6).
* Onset \< 48 hours.
* Conscious (Glasgow Coma Scale \> 8).
* Independent prior to stroke (pre-morbid Rankin scale \< 2).
* Meaningful consent, or assent from a relative or carer
Exclusion Criteria
* Contraindication to nitrate therapy
* Definite need for prior antihypertensive or anti-anginal medication
* Definite need for antihypertensive therapy during acute stroke
* Systolic blood pressure \<140 mmHg or \>220 mmHg.
* Patients expected to require surgical intervention
* Known intracerebral pathology other than stroke
* Other serious condition which is likely to prevent outcome assessment at 3 months
* Previous enrollment in ENOS or current involvement in another trial of an experimental drug intervention.
* Not available for follow-up -Females of childbearing potential, pregnancy or breastfeeding. -
18 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Philip Bath
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Nottingham University Hospitals NHS Trust (City Hospital)
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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References
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Learoyd AE, Woodhouse L, Shaw L, Sprigg N, Bereczki D, Berge E, Caso V, Christensen H, Collins R, Czlonkowska A, El Etribi A, Farr TD, Gommans J, Laska AC, Ntaios G, Ozturk S, Pocock SJ, Prasad K, Wardlaw JM, Fone KC, Bath PM, Trueman RC; ENOS Trial investigators. Infections Up to 76 Days After Stroke Increase Disability and Death. Transl Stroke Res. 2017 Dec;8(6):541-548. doi: 10.1007/s12975-017-0553-3. Epub 2017 Jul 27.
Woodhouse L, Scutt P, Krishnan K, Berge E, Gommans J, Ntaios G, Wardlaw J, Sprigg N, Bath PM; ENOS Investigators. Effect of Hyperacute Administration (Within 6 Hours) of Transdermal Glyceryl Trinitrate, a Nitric Oxide Donor, on Outcome After Stroke: Subgroup Analysis of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial. Stroke. 2015 Nov;46(11):3194-201. doi: 10.1161/STROKEAHA.115.009647. Epub 2015 Oct 13.
Related Links
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Related Info
Other Identifiers
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ISRCTN99414122
Identifier Type: -
Identifier Source: secondary_id
EudraCT no: 2004-003870-27
Identifier Type: -
Identifier Source: secondary_id
04002
Identifier Type: -
Identifier Source: org_study_id