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
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 p...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-06-01
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| Series: | BMJ Neurology Open |
| Online Access: | https://neurologyopen.bmj.com/content/5/1/e000424.full |
| _version_ | 1828717085726867456 |
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| author | Joanna M Wardlaw Jeffrey L Saver Philip M Bath Thompson G Robinson Keith Muir Jason P Appleton Lisa J Woodhouse Nikola Sprigg Marc Randall Christine Roffe Else C Sandset Christopher I Price Grant Mair Stuart Pocock Timothy J England Aloysius Niroshan Siriwardena Sandeep Ankolekar |
| author_facet | Joanna M Wardlaw Jeffrey L Saver Philip M Bath Thompson G Robinson Keith Muir Jason P Appleton Lisa J Woodhouse Nikola Sprigg Marc Randall Christine Roffe Else C Sandset Christopher I Price Grant Mair Stuart Pocock Timothy J England Aloysius Niroshan Siriwardena Sandeep Ankolekar |
| author_sort | Joanna M Wardlaw |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T14:22:47Z |
| format | Article |
| id | doaj.art-ce3eabd18ce34e35918de9d48eace3e2 |
| institution | Directory Open Access Journal |
| issn | 2632-6140 |
| language | English |
| last_indexed | 2024-03-12T14:22:47Z |
| publishDate | 2023-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Neurology Open |
| spelling | doaj.art-ce3eabd18ce34e35918de9d48eace3e22023-08-18T15:30:07ZengBMJ Publishing GroupBMJ Neurology Open2632-61402023-06-015110.1136/bmjno-2023-000424Prehospital 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 trialJoanna M Wardlaw0Jeffrey L Saver1Philip M Bath2Thompson G Robinson3Keith Muir4Jason P Appleton5Lisa J Woodhouse6Nikola Sprigg7Marc Randall8Christine Roffe9Else C Sandset10Christopher I Price11Grant Mair12Stuart Pocock13Timothy J England14Aloysius Niroshan Siriwardena15Sandeep Ankolekar16UK Dementia Research Institute, The University of Edinburgh Centre for Clinical Brain Sciences, Edinburgh, UKDepartment of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, Los Angeles, California, USAStroke, Nottingham University Hospitals NHS Trust, Nottingham, UKCollege of Life Sciences, University of Leicester, Leicester, UKNeurology, University of Glasgow, Glasgow, UKStroke, Nottingham University Hospitals NHS Trust, Nottingham, UKStroke Trials Unit, Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UKStroke, Nottingham University Hospitals NHS Trust, Nottingham, UKDepartment of Neurology, Leeds Teaching Hospitals NHS Trust, Leeds, UKStroke Research, School of Medicine, University of Keele, Stoke-on-Trent, UKDepartment of Neurology, Oslo University Hospital, Oslo, NorwayInstitute of Neuroscience, Newcastle University, Newcastle upon Tyne, UKUK Dementia Research Institute, The University of Edinburgh Centre for Clinical Brain Sciences, Edinburgh, UKDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UKStroke Trials Unit, Mental Health and Clinical Neurosciences, University of Nottingham, Nottingham, UKCommunity and Health Research Unit, University of Lincoln, Lincoln, UKDepartment of Neurology, King`s College Hospital NHS Trust, London, UKBackground 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.https://neurologyopen.bmj.com/content/5/1/e000424.full |
| spellingShingle | Joanna M Wardlaw Jeffrey L Saver Philip M Bath Thompson G Robinson Keith Muir Jason P Appleton Lisa J Woodhouse Nikola Sprigg Marc Randall Christine Roffe Else C Sandset Christopher I Price Grant Mair Stuart Pocock Timothy J England Aloysius Niroshan Siriwardena Sandeep Ankolekar 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 BMJ Neurology Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://neurologyopen.bmj.com/content/5/1/e000424.full |
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