The Efficacy of Nitric Oxide in Stroke (ENOS) Trial
ENOS
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
3 other identifiers
interventional
3,500
1 country
1
Brief Summary
Nitric oxide is a multimodal candidate treatment for acute stroke having a number of properties which may be beneficial in acute stroke, including lowering blood pressure, causing cerebral vasodilation, and improving central and systemic haemodynamics. Nitric oxide donors are effective in experimental stroke and pilot studies in patients suggest that one, glyceryl trinitrate, can be delivered easily in a transdermal preparation. Around half of all patients admitted with acute stroke are taking antihypertensive therapy immediately prior to their stroke. No data exist as to whether it is beneficial or safe to stop or continue this treatment during the acute phase. ENOS is a prospective, international, multicentre, randomised, parallel-group, blinded, controlled, collaborative, factorial trial designed to test two questions related to the management of blood pressure immediately post-stroke:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 stroke
Started Jul 2001
Longer than P75 for phase_3 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJuly 24, 2012
July 1, 2012
12.3 years
October 2, 2009
July 23, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Reduced death or dependency (modified Rankin score)
90 days
Study Arms (2)
Glyceryl trinitrate transdermal patch
ACTIVE COMPARATORContinue or stop pre-stroke antihypertensives
EXPERIMENTALInterventions
5mg per day
Continue or stop pre-stroke anti-hypertensives
Eligibility Criteria
You may qualify if:
- Adult(\> 18 yrs).
- 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
You may not qualify if:
- Definite need for nitrate therapy
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nottingham University Hospitals NHS Trust (City Hospital)
Nottingham, Nottinghamshire, NG5 1PJ, United Kingdom
Related Publications (2)
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.
PMID: 28752410DERIVEDWoodhouse 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.
PMID: 26463698DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Bath
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 5, 2009
Study Start
July 1, 2001
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
July 24, 2012
Record last verified: 2012-07