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Trials. 2019 Mar 25;20(1):183. doi: 10.1186/s13063-019-3270-2.

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

Author information

1
Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. rustam.al-shahi@ed.ac.uk.
2
Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK. rustam.al-shahi@ed.ac.uk.
3
Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
4
Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
5
Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
6
Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.
7
Institute of Neurology, University College London, London, UK.
8
Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle-upon-Tyne, UK.

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.

KEYWORDS:

Secondary prevention; antiplatelet therapy; intracerebral haemorrhage; randomised controlled trial; statistical analysis plan; stroke

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