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Statistical analysis plan for the ‘Efficacy of Nitric Oxide in Stroke’ (ENOS) trial

Bath, Philip M.W.; Houlton, Aimee; Woodhouse, Lisa J.; Sprigg, Nikola; Wardlaw, Joanna M.; Pocock, Stuart J.

Authors

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

Aimee Houlton

Lisa J. Woodhouse

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

Joanna M. Wardlaw

Stuart J. Pocock



Abstract

High blood pressure is common during the acute phase of stroke and is associated with a poor outcome. However, the management of high blood pressure remains unclear. The ‘Efficacy of Nitric Oxide in Stroke’ trial tested whether transdermal glyceryl trinitrate, a nitric oxide donor that lowers blood pressure, is safe and effective in improving outcome after acute stroke. Efficacy of Nitric Oxide in Stroke is an international multicenter, prospective, randomized, single-blind, blinded endpoint trial, with funding from the UK Medical Research Council. Patients with acute ischemic stroke or intracerebral hemorrhage and systolic blood pressure 140–220 mmHg were randomized to glyceryl trinitrate or no glyceryl trinitrate and, where relevant, to continue or stop prestrike antihypertensive therapy. The primary outcome is shift in modified Rankin Scale at three-months. Patients or relatives gave written informed (proxy) consent, and all sites had research ethics approval. Analyses will be done by intention to treat. This paper and attachment describe the trial’s statistical analysis plan, developed prior to unblinding of date. The statistical analysis plan contains design and methods for analyses, and unpopulated tables and figures for the two primary publications and some secondary publications. The database will be locked in late February 2014 in preparation for presentation of the results in May 2014. The data from the trial will improve the precision of the estimates of the overall treatment effects (efficacy and safety) of results from completed trials of blood pressure management in acute stroke, and provide the first large-scale randomized evidence on transdermal glyceryl trinitrate, and of continuing (vs. stopping) prestroke antihypertensive medications, in acute stroke.

Journal Article Type Article
Journal International Journal of Stroke
Print ISSN 1747-4930
Electronic ISSN 1747-4949
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 9
Issue 3
APA6 Citation Bath, P. M., Houlton, A., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., & Pocock, S. J. (in press). Statistical analysis plan for the ‘Efficacy of Nitric Oxide in Stroke’ (ENOS) trial. International Journal of Stroke, 9(3), https://doi.org/10.1111/ijs.12235
DOI https://doi.org/10.1111/ijs.12235
Keywords Acute Stroke Trial, Blood Pressure, Glyceryl Trinitrate, Intracerebral Hemorrhage, Ischemic Stroke, Statistical Analysis Plan
Publisher URL http://onlinelibrary.wiley.com/doi/10.1111/ijs.12235/abstract?
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Bath Stat Analysis lan for ENOS.pdf (70 Kb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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