We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial.
- Authors
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.
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>Final results of RESTART will be analysed and disseminated in May 2019.<bold>Trial Registration: </bold>ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.
- Subjects
FIBRINOLYTIC agents; HEMORRHAGE; STROKE; PLATELET aggregation inhibitors; ANTICOAGULANTS
- Publication
Trials, 2019, Vol 20, Issue 1, pN.PAG
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-019-3270-2