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BackgroundFor 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/designThe 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.DiscussionFinal results of RESTART will be analysed and disseminated in May 2019.Trial registrationISRCTN registry 71907627 . Prospectively registered on 25 April 2013.

Original publication

DOI

10.1186/s13063-019-3270-2

Type

Journal article

Journal

Trials

Publication Date

03/2019

Volume

20

Addresses

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.

Keywords

Humans, Cerebral Hemorrhage, Recurrence, Fibrinolytic Agents, Anticoagulants, Platelet Aggregation Inhibitors, Treatment Outcome, Drug Administration Schedule, Data Interpretation, Statistical, Risk Assessment, Risk Factors, Time Factors, Randomized Controlled Trials as Topic, Stroke, Secondary Prevention