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The Efficacy of Nitric Oxide in Stroke (ENOS) Trial

Sponsor
University of Nottingham (Other)
Overall Status
Unknown status
CT.gov ID
NCT00989716
Collaborator
(none)
3,500
Enrollment
1
Location
2
Arms
147
Duration (Months)
23.8
Patients Per Site Per Month

Study Details

Study Description

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.

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Transdermal glyceryl trinitrate patch
  • Drug: Pre-stroke antihypertensives
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jul 1, 2001
Anticipated Primary Completion Date :
Oct 1, 2013
Anticipated Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glyceryl trinitrate transdermal patch

Drug: Transdermal glyceryl trinitrate patch
5mg per day
Other Names:
  • Local ward stock to be used.

    		•
    Experimental: Continue or stop pre-stroke antihypertensives

    Drug: Pre-stroke antihypertensives
    Continue or stop pre-stroke anti-hypertensives

    Outcome Measures

    Primary Outcome Measures

    1. Reduced death or dependency (modified Rankin score) [90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nottingham University Hospitals NHS Trust (City Hospital) Nottingham Nottinghamshire United Kingdom NG5 1PJ

    Sponsors and Collaborators

    • University of Nottingham

    Investigators

    • Principal Investigator: Philip Bath, University of Nottingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Nottingham
    ClinicalTrials.gov Identifier:
    NCT00989716
    Other Study ID Numbers:
    • 04002
    • ISRCTN99414122
    • EudraCT no: 2004-003870-27
    First Posted:
    Oct 5, 2009
    Last Update Posted:
    Jul 24, 2012
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Stroke
    Antihypertensive Agents
    Nitroglycerin

    Study Results

    No Results Posted as of Jul 24, 2012