The Efficacy of Nitric Oxide in Stroke (ENOS) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Nottingham.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00989716
First received: October 2, 2009
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Stroke
Drug: Transdermal glyceryl trinitrate patch
Drug: Pre-stroke antihypertensives
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Reduced death or dependency (modified Rankin score) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3500
Study Start Date: July 2001
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glyceryl trinitrate transdermal patch Drug: Transdermal glyceryl trinitrate patch
5mg per day
Other Name: Local ward stock to be used.
Experimental: Continue or stop pre-stroke antihypertensives Drug: Pre-stroke antihypertensives
Continue or stop pre-stroke anti-hypertensives

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989716

Contacts
Contact: Philip Bath philip.bath@nottingham.ac.uk

Locations
United Kingdom
Nottingham University Hospitals NHS Trust (City Hospital) Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PJ
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Philip Bath University of Nottingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00989716     History of Changes
Other Study ID Numbers: 04002, ISRCTN99414122, EudraCT no: 2004-003870-27
Study First Received: October 2, 2009
Last Updated: July 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Antihypertensive Agents
Nitroglycerin
Nitric Oxide
Nitric Oxide Donors
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Gasotransmitters

ClinicalTrials.gov processed this record on August 28, 2014