A Phase 3 interventional study of Transdermal glyceryl trinitrate patch and Pre-stroke antihypertensives in Stroke, sponsored by University of Nottingham. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-24.
Sponsored by University of Nottingham · Phase 3, Interventional, and Treatment
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:
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).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
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Exclusion Criteria:
Drug: Transdermal glyceryl trinitrate patch
Drug: Pre-stroke antihypertensives
5mg per day
Also known as: Local ward stock to be used.
Continue or stop pre-stroke anti-hypertensives
Reduced death or dependency (modified Rankin score)
Time frame: 90 days
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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University of Nottingham