RIGHT
The RIGHT Trial: Rapid Intervention with Glyceryl trinitrate (GTN) in Hypertensive stroke Trial
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Purpose:
1. To assess the feasibility of performing an ambulance-based trial in patients with hyperacute stroke, a key question for the future testing of potential interventions aimed at neuroprotection and physiological control
2. To assess the effect of glyceryl trinitrate (GTN) on blood pressure (BP) in this setting
Location(s):
United Kingdom
Year Started:
2008
Design:
Ambulance-based, single city, single-blind, randomised controlled trial with blinded outcome assessment.
Inclusion Criteria
1. Adult patients of either sex; males more than 40 years and females ≥ 55 years
2. Paramedic assessment of stroke on basis of positive ‘Face & Arm weakness and Speech abnormality Test (FAST) in the context of a call to a patient with a ‘possible acute stroke’
3. Event less than 4 hours of onset (sleep stroke - onset as bed time)
4. High systolic BP (greater than 140 mmHg)
Exclusion Criteria
1. No consent/assent is available
2. GTN is indicated (e.g. concurrent angina)
3. GTN is contraindicated (e.g. dehydration, hypovolaemia)
4. Coma; Glasgow Coma Scale (GCS) score less than or equal to 8
5. History of seizures
6. Non-ambulatory pre-morbidly (modified Rankin scale of greater than 2)
7. Hypoglycaemia (if glucose tested)
6. Patients from a nursing home
Patient Involvement:
Transdermal GTN (5 mg) or no patch.
Total duration of treatment: 7 days
Total duration of follow up: 90 days
Primary Outcome:
To assess the feasibility of using the ambulance service to test and deliver treatment for stroke in the hyperacute setting, will be measured as effects of GTN on blood pressure at 2 hours post-treatment.
Secondary Outcome:
To assess the effects of GTN on:
1. Blood pressure
2. Pulse pressure (PP)
3. Rate pressure product (RPP)
4. Surrogate markers of efficacy in blood in the hyperacute setting
Measured in hospital, day 7/discharge/death, and day 90.
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Source of Information:
ControlledClinicalTrials.com
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Web Links and Publications:
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This information last updated on: 10/19/2009
Reviewed on: 09/15/2009.
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