The Efficacy of Nitric Oxide in Stroke (ENOS) Trial
Status:
Unknown status
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
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).