Condition category
Circulatory System
Date applied
18/02/2008
Date assigned
09/05/2008
Last edited
21/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
Philip.bath@nottingham.ac.uk
Dr Sandeep Ankolekar
Sandeep.ankolekar@nottingham.ac.uk

Trial website

http://www.right-trial.org/

Contact information

Type

Scientific

Primary contact

Prof Philip Bath

ORCID ID

Contact details

Division of Stroke Medicine
University of Nottingham
Clinical Sciences Building
City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 823 1765
philip.bath@nottingham.ac.uk

Additional identifiers

EudraCT number

2007-004766-40

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

RIGHT

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Acute stroke

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Glyceryl trinitrate

Primary outcome measures

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

01/03/2008

Overall trial end date

15/03/2012

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/02/2010

Recruitment end date

01/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

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
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 951 5670
Paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Division of Stroke, University of Nottingham

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23125943
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24003041

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