Skip to main content

Research Repository

See what's under the surface

Advanced Search

Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053)

Appleton, Jason P.; Scutt, Polly; Dixon, Mark; Howard, Harriet; Haywood, Lee; Havard, Diane; Hepburn, Trish; England, Timothy J.; Sprigg, Nikola; Woodhouse, Lisa J.; Wardlaw, Joanna M.; Montgomery, Alan A.; Pocock, Stuart J.; Bath, Philip M.W.

Authors

Jason P. Appleton

Polly Scutt

Mark Dixon

Harriet Howard

Lee Haywood

Diane Havard

Trish Hepburn

Timothy J. England

Nikola Sprigg

Lisa J. Woodhouse

Joanna M. Wardlaw

Alan A. Montgomery

Stuart J. Pocock

Philip M.W. Bath



Abstract

Rationale: Vascular nitric oxide levels are low in acute stroke and donors such as glyceryl trinitrate have shown promise when administered very early after stroke. Potential mechanisms of action include augmentation of cerebral reperfusion, thrombolysis and thrombectomy, lowering blood pressure, and cytoprotection.
Aim: To test the safety and efficacy of four days of transdermal glyceryl trinitrate (5 mg/day) versus sham in patients with ultra-acute presumed stroke who are recruited by paramedics prior to hospital presentation.
Sample size estimates: The sample size of 850 patients will allow a shift in the modified Rankin Scale with odds ratio 0.70 (glyceryl trinitrate versus sham, ordinal logistic regression) to be detected with 90% power at 5% significance (two-sided).
Design: The Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) is a multicentre UK prospective randomized sham-controlled outcome-blinded parallel-group trial in 850 patients with ultra-acute (4 h of onset) FAST-positive presumed stroke and systolic blood pressure 120 mmHg who present to the ambulance service following a 999 emergency call. Data collection is performed via a secure internet site with real-time data validation.
Study outcomes: The primary outcome is the modified Rankin Scale measured centrally by telephone at 90 days and masked to treatment. Secondary outcomes include: blood pressure, impairment, recurrence, dysphagia, neuroimaging markers of the acute lesion including vessel patency, discharge disposition, length of stay, death, cognition, quality of life, and mood. Neuroimaging and serious adverse events are adjudicated blinded to treatment.
Discussion: RIGHT-2 has recruited more than 500 participants from seven UK ambulance services.
Status: Trial is ongoing.
Funding: British Heart Foundation.
Registration: ISRCTN26986053.

Journal Article Type Article
Journal International Journal of Stroke
Print ISSN 1747-4930
Electronic ISSN 1747-4949
Publisher SAGE Publications (UK and US)
Peer Reviewed Peer Reviewed
APA6 Citation Appleton, J. P., Scutt, P., Dixon, M., Howard, H., Haywood, L., Havard, D., …Bath, P. M. (in press). Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053). International Journal of Stroke, doi:10.1177/1747493017724627
DOI https://doi.org/10.1177/1747493017724627
Keywords Acute stroke, ambulance, antihypertensive therapy, cerebrovascular disorders, glyceryl trinitrate, nitroglycerin, paramedic, randomized controlled trial
Publisher URL http://journals.sagepub.com/doi/10.1177/1747493017724627
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf

Files

Accepted Manuscript - Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke- rationale design and protocol for the Ra.pdf (465 Kb)
PDF

Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





You might also like



Downloadable Citations

;