Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2
| ISRCTN | ISRCTN26986053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26986053 |
| EudraCT/CTIS number | 2015-000115-40 |
| Secondary identifying numbers | 18362 |
- 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
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
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 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(s) | 15/EM/0055 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Glyceryl Trinitrate |
| Primary outcome measure | Death/dependence/independence: 7-level modified Rankin Scale 90 days after stroke |
| Secondary outcome measures | N/A |
| Overall study start date | 01/05/2015 |
| Overall study end date | 31/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 850; UK Sample Size: 850 |
| Total final enrolment | 1149 |
| 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 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
- England
- United Kingdom
Study participating centre
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Hospital/treatment centre
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
"ROR" |
https://ror.org/01ee9ar58 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | The results will be published in February 2019. |
| 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 | |
| Protocol article | protocol | 01/02/2019 | 28/11/2019 | Yes | No |
| Other publications | baseline characteristics | 01/04/2019 | 22/01/2020 | Yes | No |
| Results article | results | 01/11/2019 | 31/03/2020 | Yes | No |
| Results article | 21/11/2022 | 22/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | 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 |
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.
