Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’
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 st...
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| Format: | Article |
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SAGE
2018
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| Online Access: | https://eprints.nottingham.ac.uk/49643/ |
| _version_ | 1848798044998336512 |
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| author | 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. |
| author_facet | 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. |
| author_sort | Scutt, Polly |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:13:31Z |
| format | Article |
| id | nottingham-49643 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:13:31Z |
| publishDate | 2018 |
| publisher | SAGE |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-496432020-05-04T19:38:56Z https://eprints.nottingham.ac.uk/49643/ 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. 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. SAGE 2018-06-01 Article PeerReviewed Scutt, Polly, Appleton, Jason P., Dixon, Mark, Woodhouse, Lisa J., Sprigg, Nikola, Wardlaw, Joanna M., Montgomery, Alan A., Pocock, Stuart J. and Bath, Philip M.W. (2018) Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’. European Stroke Journal, 3 (2). pp. 193-196. ISSN 2396-9881 Acute stroke; Antihypertensive therapy; Glyceryl trinitrate; Nitroglycerin; Randomised controlled trial; Cerebrovascular disorders; Statistical analysis plan https://doi.org/10.1177/2396987318756696 doi:10.1177/2396987318756696 doi:10.1177/2396987318756696 |
| spellingShingle | Acute stroke; Antihypertensive therapy; Glyceryl trinitrate; Nitroglycerin; Randomised controlled trial; Cerebrovascular disorders; Statistical analysis plan 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)’ |
| title | Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ |
| title_full | Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ |
| title_fullStr | Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ |
| title_full_unstemmed | Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ |
| title_short | Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ |
| title_sort | statistical analysis plan for the ‘rapid intervention with glyceryl trinitrate in hypertensive stroke trial-2 (right-2)’ |
| topic | Acute stroke; Antihypertensive therapy; Glyceryl trinitrate; Nitroglycerin; Randomised controlled trial; Cerebrovascular disorders; Statistical analysis plan |
| url | https://eprints.nottingham.ac.uk/49643/ https://eprints.nottingham.ac.uk/49643/ https://eprints.nottingham.ac.uk/49643/ |