Status:
UNKNOWN
The Efficacy of Nitric Oxide in Stroke (ENOS) Trial
Lead Sponsor:
University of Nottingham
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 vasodilatio...
Eligibility Criteria
Inclusion
- 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
- 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. -
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT00989716
Start Date
July 1 2001
End Date
October 1 2013
Last Update
July 24 2012
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust (City Hospital)
Nottingham, Nottinghamshire, United Kingdom, NG5 1PJ