The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
Abstract 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 therap...
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doaj-80133f037dde4280b57b091329a9fea92020-11-25T02:24:20ZengBMCTrials1745-62152019-03-012011810.1186/s13063-019-3270-2The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trialRustam Al-Shahi Salman0Gordon D. Murray1Martin S. Dennis2David E. Newby3Peter A. G. Sandercock4Nikola Sprigg5Cathie L. M. Sudlow6David J. Werring7Philip M. White8William N. Whiteley9Centre for Clinical Brain Sciences, University of EdinburghUsher Institute of Population Health Sciences and Informatics, University of EdinburghCentre for Clinical Brain Sciences, University of EdinburghCentre for Cardiovascular Science, University of EdinburghCentre for Clinical Brain Sciences, University of EdinburghFaculty of Medicine & Health Sciences, University of NottinghamCentre for Clinical Brain Sciences, University of EdinburghInstitute of Neurology, University College LondonInstitute of Neuroscience and Newcastle University Institute for AgeingCentre for Clinical Brain Sciences, University of EdinburghAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3270-2Secondary preventionantiplatelet therapystrokeintracerebral haemorrhagerandomised controlled trialstatistical analysis plan |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Rustam Al-Shahi Salman Gordon D. Murray Martin S. Dennis David E. Newby Peter A. G. Sandercock Nikola Sprigg Cathie L. M. Sudlow David J. Werring Philip M. White William N. Whiteley |
spellingShingle |
Rustam Al-Shahi Salman Gordon D. Murray Martin S. Dennis David E. Newby Peter A. G. Sandercock Nikola Sprigg Cathie L. M. Sudlow David J. Werring Philip M. White William N. Whiteley The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial Trials Secondary prevention antiplatelet therapy stroke intracerebral haemorrhage randomised controlled trial statistical analysis plan |
author_facet |
Rustam Al-Shahi Salman Gordon D. Murray Martin S. Dennis David E. Newby Peter A. G. Sandercock Nikola Sprigg Cathie L. M. Sudlow David J. Werring Philip M. White William N. Whiteley |
author_sort |
Rustam Al-Shahi Salman |
title |
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_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_sort |
restart or stop antithrombotics randomised trial (restart) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-03-01 |
description |
Abstract 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. |
topic |
Secondary prevention antiplatelet therapy stroke intracerebral haemorrhage randomised controlled trial statistical analysis plan |
url |
http://link.springer.com/article/10.1186/s13063-019-3270-2 |
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