The Efficacy of Nitric Oxide in Stroke (ENOS) Trial (ENOS)
Recruitment status was: Recruiting
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:
- The safety and efficacy of nitric oxide, given as transdermal glyceryl trinitrate.
- 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).
|Stroke||Drug: Transdermal glyceryl trinitrate patch Drug: Pre-stroke antihypertensives||Phase 3|
|Study Design:||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|
- Reduced death or dependency (modified Rankin score) [ Time Frame: 90 days ]
|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)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989716
|Contact: Philip Bathfirstname.lastname@example.org|
|Nottingham University Hospitals NHS Trust (City Hospital)||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG5 1PJ|
|Principal Investigator:||Philip Bath||University of Nottingham|