The Efficacy of Nitric Oxide in Stroke (ENOS) Trial "ENOS"

Recruiting

Phase 3 Results N/A

Trial Description

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).

Conditions

Interventions

  • Transdermal glyceryl trinitrate patch Drug
    Other Names: Local ward stock to be used.
    Intervention Desc: 5mg per day
    ARM 1: Kind: Experimental
    Label: Glyceryl trinitrate transdermal patch
  • Pre-stroke antihypertensives Drug
    Intervention Desc: Continue or stop pre-stroke anti-hypertensives
    ARM 1: Kind: Experimental
    Label: Continue or stop pre-stroke antihypertensives

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients who are dead or dependent at 3 months 3 months Yes
Primary Reduced death or dependency (modified Rankin score) 90 days Yes

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