Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2
| ISRCTN | ISRCTN26986053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26986053 |
| Clinical Trials Information System (CTIS) | 2015-000115-40 |
| Protocol serial number | 18362 |
| Sponsor | University of Nottingham |
| Funder | British Heart Foundation |
- Submission date
- 04/03/2015
- Registration date
- 05/03/2015
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Nottingham City Hospital
Division of Stroke Medicine
The University of Nottingham
Clinical Sciences Building, Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | RIGHT-2 |
| Study objectives | 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(s) | 15/EM/0055 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Glyceryl Trinitrate |
| Primary outcome measure(s) |
Death/dependence/independence: 7-level modified Rankin Scale 90 days after stroke |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 31/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 850 |
| Total final enrolment | 1149 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/02/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Nottingham
NG5 1PB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/03/2019 | Yes | No | |
| Results article | results | 01/11/2019 | 31/03/2020 | Yes | No |
| Results article | 21/11/2022 | 22/11/2022 | Yes | No | |
| Results article | 1 year post randomisation | 27/06/2023 | 14/08/2023 | Yes | No |
| Results article | Narrative data | 29/11/2023 | 01/12/2023 | Yes | No |
| Results article | Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial | 08/06/2023 | 23/04/2025 | Yes | No |
| Protocol article | protocol | 01/02/2019 | 28/11/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | baseline characteristics | 01/04/2019 | 22/01/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/04/2025: Publication reference added.
01/12/2023: Publication reference added.
14/08/2023: Publication reference added.
22/11/2022: Publication reference added.
31/03/2020: Publication reference added.
22/01/2020: Publication reference and total final enrolment number added.
28/11/2019: Publication reference added.
11/02/2019: Publication reference added.
07/02/2019: The following changes were made:
1. The overall trial end date was changed from 01/02/2018 to 31/10/2018.
2. The intention to publish date was added.
3. The publication and dissemination plan was added.
