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Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): Effects on outcomes at day 365 in a randomised, sham-controlled, blinded, phase III, superiority ambulance-based trial

Lookup NU author(s): Dr Christopher Price

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.Background The Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial-2 (RIGHT-2) reported no overall treatment difference between glyceryl trinitrate (GTN) and sham at day 90. Here we assess participants' outcomes 1 year after randomisation. Methods RIGHT-2 was an ambulance-based prospective randomised controlled trial where patients with presumed stroke and systolic blood pressure (BP) of >120 mm Hg received either GTN (5 mg/day) or sham patch. Centralised blinded telephone follow-up was performed at days 90 (primary endpoint) and 365 (secondary endpoint). The lead outcome was dependency assessed with the modified Rankin Scale (mRS). Results 1149 patients were recruited to RIGHT-2 between October 2015 and May 2018, and 1097 (95.5%) had outcome data recorded at day 365. At baseline, the patients were; female (48%), had a mean age of 73 (15) years, BP of 162 (25)/92 (18) mm Hg, onset to randomisation of 70 (45-115) min, diagnosis of ischaemic stroke (52%), intracerebral haemorrhage (ICH) (13%), transient ischaemic attack (TIA) (9%) and mimics (26%). There was no effect of GTN on mRS score at day 365 in participants with confirmed stroke/TIA (adjusted common odds ratio (acOR) 1.10, 95% CI 0.86 to 1.42) or in all patients. In patients randomised to GTN, mRS at day 365 tended to be worse in those with ICH (acOR 1.65, 95% CI 0.84 to 3.25) and better in those with a mimic diagnosis (acOR 0.53, 95% CI 0.33 to 0.84). Conclusion At 1 year post randomisation, dependency did not differ between GTN and sham treatment in either the target population or overall. In prespecified subgroup analyses, GTN was associated with reduced dependency in participants with a final diagnosis of mimic and a non-significant worse outcome in participants with ICH. Trial registration number ISRCTN26986053.


Publication metadata

Author(s): Woodhouse LJ, Appleton JP, Ankolekar S, England TJ, Mair G, Muir K, Price CI, Pocock S, Randall M, Robinson TG, Roffe C, Sandset EC, Saver JL, Siriwardena AN, Sprigg N, Wardlaw JM, Bath PM

Publication type: Article

Publication status: Published

Journal: BMJ Neurology Open

Year: 2023

Volume: 5

Issue: 1

Online publication date: 27/06/2023

Acceptance date: 11/05/2023

Date deposited: 04/08/2023

ISSN (electronic): 2632-6140

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjno-2023-000424

DOI: 10.1136/bmjno-2023-000424


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Funding

Funder referenceFunder name
571281
British Heart Foundation
National Institute for Health Research (NIHR) Clinical Research Network

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