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

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

doi:10.1177/2396987318756696

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

Eur Stroke J. 2018 Jun;3(2):193-196. doi: 10.1177/2396987318756696. Epub 2018 Feb 1.

Authors

Polly Scutt¹, Jason P Appleton¹, Mark Dixon¹, Lisa J Woodhouse¹, Nikola Sprigg¹, Joanna M Wardlaw², Alan A Montgomery³, Stuart Pocock⁴, Philip M Bath¹

Affiliations

¹ 1Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
² Neuroimaging Sciences, University of Edinburgh, Edinburgh, UK.
³ 3Clinical Trials Unit, University of Nottingham, Nottingham, UK.
⁴ 4Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

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.

Keywords: Acute stroke; antihypertensive therapy; cerebrovascular disorders; glyceryl trinitrate; nitroglycerin; randomised controlled trial; statistical analysis plan.