Jason P. Appleton
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.
POLLY SCUTT Polly.Scutt@nottingham.ac.uk
TRISH HEPBURN Trish.Hepburn@nottingham.ac.uk
Senior Medical Statistician
Timothy J. England
NIKOLA SPRIGG firstname.lastname@example.org
Professor of Stroke Medicine
Lisa J. Woodhouse
Joanna M. Wardlaw
Alan A. Montgomery
Stuart J. Pocock
Philip M.W. Bath
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.
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, https://doi.org/10.1177/1747493017724627
|Journal Article Type||Article|
|Acceptance Date||Jul 9, 2017|
|Online Publication Date||Aug 1, 2017|
|Deposit Date||Aug 16, 2017|
|Publicly Available Date||Aug 16, 2017|
|Journal||International Journal of Stroke|
|Peer Reviewed||Peer Reviewed|
|Keywords||Acute stroke, ambulance, antihypertensive therapy, cerebrovascular disorders, glyceryl trinitrate, nitroglycerin, paramedic, randomized controlled trial|
|Copyright Statement||Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf|
Accepted Manuscript - Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke- rationale design and protocol for the Ra.pdf
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf
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