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The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifi...

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Autores principales: Al-Shahi Salman, Rustam, Murray, Gordon D., Dennis, Martin S., Newby, David E., Sandercock, Peter A. G., Sprigg, Nikola, Sudlow, Cathie L. M., Werring, David J., White, Philip M., Whiteley, William N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434884/
https://www.ncbi.nlm.nih.gov/pubmed/30909946
http://dx.doi.org/10.1186/s13063-019-3270-2
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author Al-Shahi Salman, Rustam
Murray, Gordon D.
Dennis, Martin S.
Newby, David E.
Sandercock, Peter A. G.
Sprigg, Nikola
Sudlow, Cathie L. M.
Werring, David J.
White, Philip M.
Whiteley, William N.
author_facet Al-Shahi Salman, Rustam
Murray, Gordon D.
Dennis, Martin S.
Newby, David E.
Sandercock, Peter A. G.
Sprigg, Nikola
Sudlow, Cathie L. M.
Werring, David J.
White, Philip M.
Whiteley, William N.
author_sort Al-Shahi Salman, Rustam
collection PubMed
description BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy. METHODS/DESIGN: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan. DISCUSSION: Final results of RESTART will be analysed and disseminated in May 2019. TRIAL REGISTRATION: ISRCTN registry 71907627. Prospectively registered on 25 April 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3270-2) contains supplementary material, which is available to authorized users.
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spelling pubmed-64348842019-04-08 The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial Al-Shahi Salman, Rustam Murray, Gordon D. Dennis, Martin S. Newby, David E. Sandercock, Peter A. G. Sprigg, Nikola Sudlow, Cathie L. M. Werring, David J. White, Philip M. Whiteley, William N. Trials Update BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy. METHODS/DESIGN: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan. DISCUSSION: Final results of RESTART will be analysed and disseminated in May 2019. TRIAL REGISTRATION: ISRCTN registry 71907627. Prospectively registered on 25 April 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3270-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-03-25 /pmc/articles/PMC6434884/ /pubmed/30909946 http://dx.doi.org/10.1186/s13063-019-3270-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Update
Al-Shahi Salman, Rustam
Murray, Gordon D.
Dennis, Martin S.
Newby, David E.
Sandercock, Peter A. G.
Sprigg, Nikola
Sudlow, Cathie L. M.
Werring, David J.
White, Philip M.
Whiteley, William N.
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
title The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
title_full The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
title_fullStr The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
title_full_unstemmed The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
title_short The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
title_sort restart or stop antithrombotics randomised trial (restart) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434884/
https://www.ncbi.nlm.nih.gov/pubmed/30909946
http://dx.doi.org/10.1186/s13063-019-3270-2
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