Literature DB >> 31008350

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

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

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.

Entities:  

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

Year:  2018        PMID: 31008350      PMCID: PMC6460414          DOI: 10.1177/2396987318756696

Source DB:  PubMed          Journal:  Eur Stroke J        ISSN: 2396-9873


  37 in total

Review 1.  The potential of nitric oxide therapeutics in stroke.

Authors:  M R Willmot; P M W Bath
Journal:  Expert Opin Investig Drugs       Date:  2003-03       Impact factor: 6.206

2.  Relationship between outcome and baseline blood pressure and other haemodynamic measures in acute ischaemic stroke: data from the TAIST trial.

Authors:  Nikola Sprigg; Laura J Gray; Philip M W Bath; Gudrun Boysen; Peter Paul De Deyn; Pal Friis; Didier Leys; Reijo Marttila; Jan-Edwin Olsson; Desmond O'Neill; Bernd Ringelstein; Jan-Jacob van der Sande; Ewa Lindenstrøm
Journal:  J Hypertens       Date:  2006-07       Impact factor: 4.844

3.  Transdermal glyceryl trinitrate lowers blood pressure and maintains cerebral blood flow in recent stroke.

Authors:  Mark Willmot; Andrew Ghadami; Beverly Whysall; Wim Clarke; Joanna Wardlaw; Philip M W Bath
Journal:  Hypertension       Date:  2006-05-08       Impact factor: 10.190

4.  Blood pressure and clinical outcomes in the International Stroke Trial.

Authors:  Jo Leonardi-Bee; Philip M W Bath; Stephen J Phillips; Peter A G Sandercock
Journal:  Stroke       Date:  2002-05       Impact factor: 7.914

Review 5.  Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials.

Authors:  R Collins; S MacMahon
Journal:  Lancet       Date:  2001-02-03       Impact factor: 79.321

6.  Prehospital neuroprotective therapy for acute stroke: results of the Field Administration of Stroke Therapy-Magnesium (FAST-MAG) pilot trial.

Authors:  Jeffrey L Saver; Chelsea Kidwell; Marc Eckstein; Sidney Starkman
Journal:  Stroke       Date:  2004-03-11       Impact factor: 7.914

Review 7.  A systematic review of nitric oxide donors and L-arginine in experimental stroke; effects on infarct size and cerebral blood flow.

Authors:  Mark Willmot; Laura Gray; Claire Gibson; Sean Murphy; Philip M W Bath
Journal:  Nitric Oxide       Date:  2005-05       Impact factor: 4.427

8.  The effect of transdermal glyceryl trinitrate, a nitric oxide donor, on blood pressure and platelet function in acute stroke.

Authors:  P M Bath; R Pathansali; R Iddenden; F J Bath
Journal:  Cerebrovasc Dis       Date:  2001       Impact factor: 2.762

Review 9.  High blood pressure in acute stroke and subsequent outcome: a systematic review.

Authors:  Mark Willmot; Jo Leonardi-Bee; Philip M W Bath
Journal:  Hypertension       Date:  2003-12-08       Impact factor: 10.190

10.  The Virtual International Stroke Trials Archive.

Authors:  Myzoon Ali; Philip M W Bath; John Curram; Stephen M Davis; Hans-Christoph Diener; Geoffrey A Donnan; Marc Fisher; Barbara A Gregson; James Grotta; Werner Hacke; Michael G Hennerici; Marc Hommel; Markku Kaste; John R Marler; Ralph L Sacco; Philip Teal; Nils-Gunnar Wahlgren; Steven Warach; Christopher J Weir; Kennedy R Lees
Journal:  Stroke       Date:  2007-04-19       Impact factor: 7.914

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  3 in total

1.  Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial.

Authors: 
Journal:  Lancet       Date:  2019-02-06       Impact factor: 79.321

2.  Pre-hospital transdermal glyceryl trinitrate in patients with stroke mimics: data from the RIGHT-2 randomised-controlled ambulance trial.

Authors:  Bronwyn Tunnage; Lisa J Woodhouse; Mark Dixon; Craig Anderson; Sandeep Ankolekar; Jason Appleton; Lesley Cala; Timothy England; Kailash Krishnan; Diane Havard; Grant Mair; Keith Muir; Steve Phillips; John Potter; Christopher Price; Marc Randall; Thompson G Robinson; Christine Roffe; Else Sandset; Niro Siriwardena; Polly Scutt; Joanna M Wardlaw; Nikola Sprigg; Philip M Bath
Journal:  BMC Emerg Med       Date:  2022-01-10

3.  Prehospital Transdermal Glyceryl Trinitrate for Ultra-Acute Intracerebral Hemorrhage: Data From the RIGHT-2 Trial.

Authors:  Philip M Bath; Lisa J Woodhouse; Kailash Krishnan; Jason P Appleton; Craig S Anderson; Eivind Berge; Lesley Cala; Mark Dixon; Timothy J England; Peter J Godolphin; Trish Hepburn; Grant Mair; Alan A Montgomery; Stephen J Phillips; John Potter; Chris I Price; Marc Randall; Thompson G Robinson; Christine Roffe; Peter M Rothwell; Else C Sandset; Nerses Sanossian; Jeffrey L Saver; A Niroshan Siriwardena; Graham Venables; Joanna M Wardlaw; Nikola Sprigg
Journal:  Stroke       Date:  2019-10-07       Impact factor: 7.914

  3 in total

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