Plain English Summary
Background and study aims
Stroke is a serious, life-threatening medical condition that usually happens when a blood clot or haemorrhage cuts of the blood supply to an area of the brain. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs, but includes paralysis, muscle weakness and speech difficulties. A stroke can also have an impact on the sufferers emotions and can lead to anxiety, depression and personality changes. 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.
Who can participate?
Adult patients presenting to paramedics as having a stroke. The stroke should have occurred no more than 4 hours ago and the patients systolic BP >=120 mmHg
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given GTN patches for 4 days. Those in group 2 are given sham (dummy) patches for 4 days. The patches are unmarked and are covered with a gauze dressing so that participant, relatives and staff who are not putting the patches on don’t know what treatment has been given. The paramedic and hospital staff putting the patch on do know what treatment the patient has. Paramedics 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 has all the care they would normally get for their stroke. In addition, they have a second CT scan on Day 2. They are telephoned 3 months and then 1 year after their stroke and asked various structured questions to determine their recovery. When settled in hospital, participants may be asked to agree to some extra procedures or give extra blood samples for research by a member of the research team. Participants do not need to take part in any of this additional research.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Nottingham City Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2015 to February 2018
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Mrs Diane Havard
Trial website
Additional identifiers
EudraCT number
2015-000115-40
ClinicalTrials.gov number
Protocol/serial number
18362
Study information
Scientific title
Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 (RIGHT2): assessment of safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial
Acronym
RIGHT-2
Study hypothesis
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.
Ethics approval
15/EM/0055
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Stroke; Subtopic: Acute Care; Disease: In hospital study
Intervention
Transdermal Glyceryl Trinitrate patch 5mg, daily for 4 days or sham patch for 4 days.
Intervention type
Drug
Phase
Phase III
Drug names
Glyceryl Trinitrate
Primary outcome measure
Death/dependence/independence: 7-level modified Rankin Scale 90 days after stroke
Secondary outcome measures
N/A
Overall trial start date
01/05/2015
Overall trial end date
31/10/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients presenting to paramedics in context of 999 ambulance call for ‘stroke’
2. Age 18 years or more (there is no maximum age)
3. ‘Face/Arm/Speech’ Time (FAST) score >1
4. Time <=4 hours of onset
5. Systolic BP >=120 mmHg
6. Have provided informed consent, or a relative/paramedic has provided proxy consent
7. Paramedic is trained in RIGHT2 procedures, is from a participating ambulance station and will take patient to a participating comprehensive/primary stroke centre
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 850; UK Sample Size: 850
Participant exclusion criteria
1. Patient at a Nursing or Care Home
2. Glucose (BM stix) <2.5 mmol/l
3. Glasgow Coma Scale <8
4. Witnessed seizure/fit at presentation
5. Known life expectancy <6 months
6. Known to have taken a PDE5 inhibitor, such as sildenafil, in previous day before stroke
7. Known sensitivity to Transiderm Nitro patch
8. Known sensitivity to Duoderm hydrocolloid dressing
Recruitment start date
01/05/2015
Recruitment end date
01/02/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nottingham City Hospital
Division of Stroke Medicine
Nottingham
NG5 1PB
United Kingdom
Funders
Funder type
Charity
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results will be published in February 2019.
Intention to publish date
28/02/2019
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30738649