ISRCTN: 26986053

Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial 2

RIGHT-2

Information for paramedics and medical staff

The Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial-2 (RIGHT-2) is a clinical trial assessing the safety and efficacy of transdermal glyceryl trinitrate (GTN) patches vs. sham patch for patients suffering acute stroke when administered ultra-acutely by Paramedics in the pre-hospital setting.

It is a UK-based, multicentre prospective randomised single-blind, blinded-endpoint parallel group trial. RIGHT-2 aims to recruit 850 patients across 5+ UK ambulance trusts and will collaborate with 30+ stroke units to determine whether GTN improves outcome in patients with ultra-acute stroke.

Seeking emergency medical care in the community, time-critical patients presenting with stroke symptoms to Paramedics are now routinely conveyed to specialist hyper-acute stroke centres. Paramedics, at the forefront of pre-hospital emergency care, are well placed to begin this ultra-acute intervention to this high-risk patient group.

RIGHT-2 will also work with stroke centres across the UK who receive emergency ambulance admissions to continue the treatment with GTN patch or sham patch for three further days. The patient outcome will be measured using the modified Rankin Scale to determine death, the level of dependence or independence at 90 and 365 days post stroke.

If you are interested in having your centre join the trial, please fill in an Expression of Interest form and send to the Coordinating Centre as per details at bottom of form.

2015, February: RIGHT-2 has received Ethics approval!

RIGHT-2 trial website and database

Go to http://right-2.ac.uk/live/ for the live database. You will need to use the User ID and PIN provided in the activation email. You should have set your own password already as part of the activation process.

If you have forgotten your password, there is a reset facility at the above link.


Status

The trial is funded by the British Heart Foundation. The protocol and approvals paperwork is currently being developed in readiness for the IRAS submission: a draft protocol will be shared with potential sites shortly. We hope the trial will commence in quarter 1 of 2015, with recruitment starting in April 2015.


Tweets by @right2trial

Funding


Forthcoming events

RIGHT-2 will be attending:

News


Presentations/publications/listings/

NIHR CRN portfolio (link)

ISRCTN registration (link)


Media Coverage

Notts TV (channel 8)

Patch demonstration (.mxf), 27/05/2015
Interview with Professor Philip Bath and Adam Hayes, stroke survivor (.mxf), 27/05/2015
To view .mxf files, you may need to download VLC for free.

BBC

Early use of patch 'could help treat strokes' (link), 27/05/2015
Andy Whittaker's Breakfast Show (link) on BBC Radio Nottingham, 27/05/2015 (recording by Trials Team)

Virtual Medical Centre

Improving Stroke Outcomes (link), 10/09/2015
For the following video you will need to sign up here: this is free but only registered health professionals (who input the required registration numbers) will be able to view this video.
ENOS trial (link), 10/09/2015: RIGHT-2 is mentioned towards the end.


Select reference publications

Determining the feasibility of ambulance-based randomised controlled trials in patients with ultra-acute stroke: study protocol for RIGHT (pdf), 21 September 2012
Feasibility of an ambulance-based trial, and safety of glyceryl trinitrate in ultra-acute stroke: the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial (RIGHT) (pdf); published in Stroke, 7 June 2013
Glyceryl trinitrate vs. control, and continuing vs. stopping temporarily prior antihypertensive therapy, in acute stroke: rationale and design of the ENOS trial (pdf), November 2006


Demo/practice website and database

Go to http://right-2.ac.uk/demo/ if you wish to practice data entry etc.

Please note that data entered into this database is not entered into the live trial database and does not contribute to trial data. This database does, of course, replicate and demonstrate the same functions as the main trial database.

You will need the following credentials to log in:

User:demoinv1
Password: nottingham
PIN:8888


Study personnel

Trial Steering Committee:

Advisory Committeee:
Craig Anderson (Sydney, Australia), Eivind Berge (Oslo, Norway), Peter Rothwell (Oxford, UK), Steve Phillips (Halifax, Canada), Else Sandset (Oslo, Norway), Nerses Sanossian (Los Angeles, USA), Jeff Saver (Los Angeles, USA)

Trial Management Committee (Nottingham):
Philip Bath (Chair), Di Havard (Trial Manager), Hayley Foster (Assistant Trial Manager), Harriet Howard (Trial Coordinator), Mark Dixon (National Paramedic), Polly Scutt (Statistician), Jason Appleton (Medic), Gemma Walker (Outcome Coordinator), Lee Haywood (Programming), Dawn Hazle (Data Administration), Wim Clarke (Finance), Patricia Robinson (Secretary)

Independent Data Monitoring Committee:
Peter Sandercock (Chair; Edinburgh, UK): Kjell Asplund (Umeå, Sweden), Colin Baigent (Oxford, UK)

Independent Events (SAE) Adjudicator:
Sandeep Ankolekar (Birmingham, UK)

Neuroimaging Adjudicators:
Joanna Wardlaw (Chair; Edinburgh, UK): remaining members to be confirmed

Neuroimaging Management:
Eleni Sakka (Edinburgh, UK)

Programming/database management:
Website/Database (Nottingham, UK): Lee Haywood, Liz Walker, Dawn Hazle
Imaging (Edinburgh, UK): David Buchanan, Jeb Palmer


Contact details

RIGHT-2 Trial Office
Stroke Research Group
University of Nottingham
Clinical Sciences Building
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
UK
 
Telephone: +44 115 823 1770
Fax: +44 115 823 1771
E-mail: right-2@nottingham.ac.uk

Written by Philip Bath, last updated by Dawn Hazle 16th October 2015