Rapid Intervention with GTN in Hypertensive Stroke Trial - RIGHT-2
Research type
Research Study
Full title
Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2): Assessment of safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial
IRAS ID
167115
Contact name
Philip Bath
Contact email
Eudract number
2015-000115-40
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
It is thought that lowering blood pressure quickly after the stroke could have a beneficial effect on a patient’s recovery. Therefore, this study aims to find out whether giving patients who are suspected of having a stroke, a 5mg transdermal glyceryl trinitrate (GTN) patch (a commonly used drug in patients with heart disease) as soon as possible after stroke, and then daily for the next three days, improves outcome.
Participants will be randomised either to have GTN patches for 4 days, or to have sham patches for 4 days. The patches are unmarked and will be covered with a gauze dressing so that participant, relatives and staff who are not putting the patches on won’t know what treatment has been given. The paramedic and hospital staff putting the patch on will know what treatment the patient has.
Paramedics will obtain consent and put the first patch on, either in the participant’s home or in the ambulance, before they take the patient to the hospital.
The participant will have all the care they would normally get for their stroke. In addition, they would have a second CT scan on Day 2, which not all stroke patients get. They would be telephoned 3 months and 1 year after their stroke and asked various structured questions to determine their recovery.
When settled in hospital, participants may be asked to have some extra procedures or give extra blood samples for research by a member of the research team. This additional research will collect blood for genetic research, collect blood for research using biomarkers, collect data from 24 hour ambulatory blood pressure monitoring, collect data from Transcranial Doppler and collect data from a machine that measures the function of blood vessels. Participants do not need to take part in any of this additional research.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0055
Date of REC Opinion
24 Feb 2015
REC opinion
Further Information Favourable Opinion