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Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’

Scutt, Polly; Appleton, Jason P.; Dixon, Mark; Woodhouse, Lisa J.; Sprigg, Nikola; Wardlaw, Joanna M.; Montgomery, Alan A.; Pocock, Stuart J.; Bath, Philip M.W.

Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ Thumbnail


Authors

Polly Scutt

Jason P. Appleton

Mark Dixon

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

Joanna M. Wardlaw

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Stuart J. Pocock

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine



Abstract

Rationale: Glyceryl trinitrate, a nitric oxide donor, is a candidate treatment for acute stroke; it lowers blood pressure, does not alter cerebral blood flow or platelet function and is neuroprotective in experimental stroke. The ongoing rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial aims to assess the safety and efficacy of paramedic-delivered glyceryl trinitrate in patients with ultra-acute stroke.

Aims and design: The rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial is a multicentre UK-based prospective randomised sham-controlled outcome-blinded parallel-group trial in patients with presumed stroke who present to the ambulance service following a 999 emergency call. The primary outcome is the modified Rankin scale measured by central telephone follow-up at 90 days.

Results: This paper describes the statistical analysis plan for the rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial and was developed prior to unblinding to treatment allocation. The statistical analysis plan includes details of methods for analyses and unpopulated tables and figures to be included in the primary and other secondary publications.

Discussion: Statistical analysis plan details what analyses will be done prior to unblinding to treatment allocation to avoid bias in the findings. Rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial will determine whether glyceryl trinitrate administered ultra-acutely can improve outcome after stroke. The rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 trial is registered as ISRCTN26986053.

Citation

Scutt, P., Appleton, J. P., Dixon, M., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., …Bath, P. M. (2018). Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’. European Stroke Journal, 3(2), 193-196. https://doi.org/10.1177/2396987318756696

Journal Article Type Article
Acceptance Date Jan 3, 2018
Online Publication Date Feb 1, 2018
Publication Date Jun 1, 2018
Deposit Date Feb 7, 2018
Publicly Available Date Mar 28, 2024
Journal European Stroke Journal
Electronic ISSN 2396-9881
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 3
Issue 2
Pages 193-196
DOI https://doi.org/10.1177/2396987318756696
Keywords Acute stroke; Antihypertensive therapy; Glyceryl trinitrate; Nitroglycerin; Randomised controlled trial; Cerebrovascular disorders; Statistical analysis plan
Public URL https://nottingham-repository.worktribe.com/output/935574
Publisher URL https://doi.org/10.1177/2396987318756696
Additional Information Copyright ©2018 by European Stroke Organisation