Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial
RIGHT (ISRCTN 66434824)
The 'Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial (RIGHT)' study is a collaborative, single centre, prospective, randomised, single-blind, blinded endpoint, parallel-group, controlled trial designed to test the feasibility of:
(i) Performing stroke trials in the pre-hospital ambulance environment safely with reruitment by paramedics; and
(ii) The safety and effect of transdermal glyceryl trinitrate (a nitric oxide donor) on blood pressure in patients with hyperacute stroke
Up to 80 patients with acute presumed stroke will be enrolled by paramedics within 4 hours of the onset of stroke and treatment will be given for 7 days. The primary outcome is blood pressure at 2 hours post-treatment. Recruitment will cease in December 2011
Status
As of 31 March 2012:
Enrolled patients: 41 (Nottingham, UK)
All 41 patients have had their final follow-up at day 90, and the database is being cleaned prior o lock and analysis.
Funding
News
Reference numbers
Documents
Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
University of Nottingham 'high level' SOPs (link)
Ethics approved documents
Protocol, v1.1 (pdf file)
Supporting documents
ISRCTN: 66434824, 15/9/2008 (pdf file)
NRES/LREC: approval letter from LREC, 8/4/2009 (pdf file)
NRES/LREC: response letter to LREC, 29/3/2009 (pdf file)
NRES/LREC: approval letter (initial) from LREC, 9/2/2009 (pdf file)
NRES/LREC: application form to LREC, 23/12/2008 (pdf file)
NRES/LREC: response letter to LREC, 17/12/2008 (pdf file)
NRES/LREC: rejection letter from LREC, 5/3/2008 (pdf file)
MHRA: approval letter, 17/1/2011, qualitative substudy (pdf file)
MHRA: approval letter, 16/2/2009 (pdf file)
MHRA: application form to MHRA, 14/1/2009 (pdf file)
MHRA: sample label, 2008 (pdf file)
MHRA: rejection letter, 27/2/2008 & 13/10/2008 (pdf file)
IMP: description, 11/1/2008 (pdf file)
EUDRACT: number 2007-004766-40, 11/1/2008 (pdf file)
R&D: Nottingham University Hospitals NHS Trust, number 08SR003, 05/10/2009 (pdf file)
R&D: East Midlands Ambulance Service NHS Trust, number 09/H0409/5, 18/09/2009 (pdf file)
Sponsor/University of Nottingham: agreement, 23/4/2009 (pdf file)
Sponsor/University of Nottingham: approval letter to MHRA, 12/1/2009 (pdf file)
Insurance cover (UK) for sponsor: letter, 1/8/2008 - 31/7/2009 (pdf file)
Study personnel
Trial Steering Committee:
Philip Bath (Chair, University of Nottingham), Sandeep Ankolekar (University of Nottingham), Niro Siriwardena (East Midlands Ambulance Service)
Trial Management Committee:
Philip Bath (Chief Investigator, University of Nottingham), Sandeep Ankolekar (Trial Medic, University of Nottingham), Jennifer Eardley (Trial Champion, East Midlands Ambulance Service), Andrew Harrison (Trial Champion, East Midlands Ambulance Service), Niro Siriwardena (Principal Investigator, East Midlands Ambulance Service)
Independent Events Adjudicator:
Niki Sprigg (University of Nottingham)
Contact details
RIGHT Trial Office
Division of Stroke
Institute of Neuroscience
University of Nottingham
Clinical Sciences Building
City Hospital campus
Hucknall Road
Nottingham NG5 1PB
UK
Telephone: +44 (0)115 823 1770
Fax: +44 (0)115 823 1771
E-mail: Sandeep Ankolekar
Written by Philip Bath, last updated 31 March 2012
