Condition category
Circulatory System
Date applied
04/03/2015
Date assigned
05/03/2015
Last edited
05/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Mrs Diane Havard

ORCID ID

Contact details

Nottingham City Hospital
Division of Stroke Medicine
The University of Nottingham
Clinical Sciences Building
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

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 measures

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

01/02/2018

Reason abandoned

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

Sponsor information

Organisation

University of Nottingham

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes