Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims.
The first few hours following a stroke are critical as there may be brain cells that are at the risk of dying but may still be saved. High blood pressure following stroke is common and may impact negatively on the survival of these brain cells. Trials that have assessed the effect of lowering blood pressure following a stroke however have not shown any benefit, but this may be because treatment was often delayed by several hours by the time patients were seen in the hospital. Our goal is to assess the feasibility of using the ambulance services to deliver acute stroke treatments. In this study, paramedics will treat patients with glyceryl trinitrate (GTN), a drug that dilates blood vessels and reduces blood pressure, within 4 hours of stroke. The study will also provide important information on the effects of GTN in very acute strokes.

Who can participate?
We aim to recruit 80 patients with a stroke who are within 4 hours of onset and also have high blood pressure. Only patients who are seen by our trained paramedics in the Nottingham City, UK district will be included in the study.

What does the study involve?
Patients will be randomly allocated to receive either a dressing containing GTN or a standard gauze dressing. Paramedics will then measure the patients' blood pressure 10-15 minutes after the dressing is applied. Once in the hospital more detailed information will be given and if patients agree to continue in the study, the treatment will be continued daily for 7 days. Researchers will check the blood pressure every day and perform clinical assessments after completion of 7 days treatment. The final follow up is at 3 months and a member of the research team will do a face to face assessment of the patient, check on their condition, and ask questions about mobility, mood, memory and quality of life.

What are the possible benefits and risks of participating?
There may be no direct benefit for patients taking part in the study. The information we get from patients' involvement may benefit other people who may have a stroke in the future. All drugs have the possibility of side effects. The side effects from GTN are generally mild. They can include headache, low blood pressure and dizziness. Patients will be monitored and asked to inform the treating doctor or member of the research team if they feel they have a reaction to the medication.

Where is the study run from?
The Division of Stroke, University of Nottingham.

When is the study starting and how long is it expected to run for?
The study started recruitment in February 2010 and is expected to run until the end of December 2011.

Who is funding the study?
The Nottingham University Hospitals NHS Trust Research and Development, The Division of Stroke, University of Nottingham.

Who is the main contact?
Professor Philip Bath
Dr Sandeep Ankolekar

Trial website

Contact information



Primary contact

Prof Philip Bath


Contact details

Division of Stroke Medicine
University of Nottingham
Clinical Sciences Building
City Hospital
Hucknall Road
United Kingdom
+44 (0)115 823 1765

Additional identifiers

EudraCT number

2007-004766-40 number

Protocol/serial number


Study information

Scientific title

Determining the potential of ambulance-based randomised controlled trials in patients with hyperacute stroke: assessment of glyceryl trinitrate in lowering blood pressure



Study hypothesis

1. To assess the feasibility of performing an ambulance-based trial in patients with hyperacute stroke, a key question for the future testing of potential interventions aimed at neuroprotection and physiological control
2. To assess the effect of glyceryl trinitrate (GTN) on blood pressure (BP) in this setting

On 05/11/2012 the overall trial end date was changed from 31/12/2011 to 15/03/2012.

Ethics approval

Nottingham research ethics committee, 08/04/2009, ref: 09/H0408/5

Study design

Single-blind randomised controlled trial with blinded outcome assessment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


Acute stroke


Transdermal GTN (5 mg) or no patch.
Total duration of treatment: 7 days
Total duration of follow up: 90 days

Intervention type



Not Applicable

Drug names

Glyceryl trinitrate

Primary outcome measure

To assess the feasibility of using the ambulance service to test and deliver treatment for stroke in the hyperacute setting, will be measured as effects of GTN on blood pressure at 2 hours post-treatment.

Secondary outcome measures

Current secondary outcome measures as of 05/11/2012:
Haemodynamic outcomes
1. BP and heart rate (HR) at 15 minutes (in ambulance), 120 minutes (at hospital) and on days 2-7. BP/HR derivatives were calculated as follows:
Pulse pressure (PP) = systolic BP (SBP) - diastolic BP (DBP)
Rate pressure product = SBP x HR
2. Central BP and aortic compliance (Augmentation Index) were at 120 minutes

Clinical outcomes
1.Impairment (Scandinavian Stroke Scale, SSS) at 2 hours and day 7.
2. Other measurements at day 7 included
2.1. Recurrence
2.2. Death
2.3. Headache
2.4. Hypotension
2.5. Neurological deterioration (defined as a 5 point reduction in the SSS from Day 1 to Day 7).
3. Final clinical functional outcomes were recorded at day 90 including
3.1. Dependency (modified Rankin Scale, mRS),
3.2. Disability (Barthel Index, BI),
3.3. Cognition (Mini Mental State Examination, MMSE),
3.4. Mood (Zung Depression Index, ZDI), and
3.5. Quality of life (EuroQoL, as EQ-5D and EQ-VAS).

Ambulance trial logistics outcomes
1. Recruitment rate
2. Protocol violations
3. Final diagnosis
4. Timings between ictus, paramedic arrival and departure
5. Arrival at hospital

Previous secondary outcome measures until 05/11/2012:
To assess the effects of GTN on:
1. Blood pressure
2. Pulse pressure (PP)
3. Rate pressure product (RPP)
4. Surrogate markers of efficacy in blood in the hyperacute setting

Measured in hospital, day 7/discharge/death, and day 90.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Adult patients of either sex; greater than 40 years of age
2. Paramedic assessment of stroke on basis of positive Face & Arm weakness and Speech abnormality Test (FAST) in the context of a call to a patient with a possible acute stroke
3. Event less than 4 hours of onset (sleep stroke - onset as bed time)
4. High systolic BP (greater than 140 mmHg)

Participant type


Age group




Target number of participants

80 (41 by end of recruitment in December 2011)

Participant exclusion criteria

1. No consent/assent is available
2. GTN is indicated (e.g. concurrent angina)
3. GTN is contraindicated (e.g. dehydration, hypovolaemia)
4. Aged less than 40 years
5. Coma; Glasgow Coma Scale (GCS) score less than or equal to 8
6. History of seizures
7. Non-ambulatory pre-morbidly (modified Rankin scale of greater than 2)
8. Hypoglycaemia (if glucose tested)
9. Patients from a nursing home

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
United Kingdom

Sponsor information


University of Nottingham (UK)

Sponsor details

c/o Mr Paul Cartledge
Head of Research Grants and Research Innovation Services
King’s Meadow Campus
Lenton Lane
United Kingdom
+44 (0)115 951 5670

Sponsor type




Funder type


Funder name

Nottingham University Hospitals NHS Trust (Research &Development Pump Priming competition)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

The Division of Stroke, University of Nottingham

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2012 protocol in:
2013 results in:

Publication citations

  1. Protocol

    Ankolekar S, Sare G, Geeganage C, Fuller M, Stokes L, Sprigg N, Parry R, Siriwardena AN, Bath PM, Determining the Feasibility of Ambulance-Based Randomised Controlled Trials in Patients with Ultra-Acute Stroke: Study Protocol for the "Rapid Intervention with GTN in Hypertensive Stroke Trial" (RIGHT, ISRCTN66434824)., Stroke Res Treat, 2012, 2012, 385753, doi: 10.1155/2012/385753.

  2. Results

    Ankolekar S, Fuller M, Cross I, Renton C, Cox P, Sprigg N, Siriwardena AN, Bath PM, Feasibility of an ambulance-based stroke trial, and safety of glyceryl trinitrate in ultra-acute stroke: the rapid intervention with glyceryl trinitrate in Hypertensive Stroke Trial (RIGHT, ISRCTN66434824)., Stroke, 2013, 44, 11, 3120-3128, doi: 10.1161/STROKEAHA.113.001301.

Additional files

Editorial Notes