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 safety 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
80 patients with acute ischaemic or haemorrhagic 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
Power point presentation, V1.0 (Powerpoint) - to be added
Status
As of 6 October 2009:
Approvals: LREC (Nottingham), MHRA, R+D: EMAS, R+D: NUH
Enrolled patients: The trial will commence in October 2009
Funding
News
- October 2009: Second Investigator meeting to be held (Beechdale)
- September 2009: First Investigator meeting held (Queen's Medical Centre)
- April 2009: Local Research Ethics approval received
Reference numbers
Documents
General
To be added
Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
University of Nottingham 'high level' SOPs (link)
Data collection and other forms
To be added
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, 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 (University of Nottingham), Jennifer Eardley (Trial champion, East Midlands Ambulance Service), Andrew Harrison (Trial champion, East Midlands Ambulance Service)
Independent Data Monitoring Committee:
TBA
Independent Events Adjudicator:
Niki Sprigg (University of Nottingham)
Contact details
RIGHT Trial Office
Division of Stroke Medicine
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 6 October 2009
