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13 May 2008
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| [ Print-friendly version ] |
| The RIGHT Trial: Rapid Intervention with Glyceryl trinitrate (GTN) in Hypertensive stroke Trial |
| ISRCTN | ISRCTN66434824 |
| ClinicalTrials.gov identifier | |
| Public title | The RIGHT Trial: Rapid Intervention with Glyceryl trinitrate (GTN) in Hypertensive stroke Trial |
| Scientific title | Determining the potential of ambulance-based randomised controlled trials in patients with hyperacute stroke: assessment of glyceryl trinitrate in lowering blood pressure |
| Acronym | RIGHT |
| Serial number at source | N/A |
| Study hypothesis |
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 |
| Ethics approval | Ethics approval pending from the Nottingham Research Ethics Committee 2 as of 18/02/08 (ref: 08/H0408/18). |
| Study design | Ambulance-based, single city, single-blind, randomised controlled trial with blinded outcome assessment. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acute stroke |
| Participants - inclusion criteria |
1. Adult patients of either sex; greater than 40 years of age
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) |
| Participants - 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. Aged less than 40 years 5. Coma; Glasgow Coma Scale (GCS) score less than or equal to 8 6. History of seizures 7. Non-ambulatory pre-morbidly (modified Rankin scale of greater than 2) 8. Hypoglycaemia (if glucose tested) 9. Patients from a nursing home |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet. |
| Target number of participants | 80 |
| Interventions |
Transdermal GTN (5 mg) or no patch.
Total duration of treatment: 7 days Total duration of follow up: 90 days |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | No funding as of 19/02/08 |
| Trial website | |
| Publications | |
| Contact name | Prof Philip Bath |
| Address |
Division of Stroke Medicine
University of Nottingham Clinical Sciences Building City Hospital Hucknall Road |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Tel | +44 (0)115 823 1765 |
| Fax | +44 (0)115 823 1767 |
| philip.bath@nottingham.ac.uk | |
| Sponsor | University of Nottingham (UK) |
| Address |
c/o Mr Paul Cartledge
Head of Research Grants and Research Innovation Services King’s Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Tel | +44 (0)115 951 5670 |
| Paul.cartledge@nottingham.ac.uk | |
| Sponsor website: | http://www.nottingham.ac.uk/ |
| Date applied | 18/02/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
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