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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.

作者信息

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

机构信息

Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.

Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.

出版信息

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


DOI:10.1186/s13063-019-3270-2
PMID:30909946
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6434884/
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.

摘要

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[4]
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[5]
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[6]
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本文引用的文献

[1]
Absolute risk and predictors of the growth of acute spontaneous intracerebral haemorrhage: a systematic review and meta-analysis of individual patient data.

Lancet Neurol. 2018-8-14

[2]
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial.

Trials. 2018-3-5

[3]
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.

Circulation. 2018-2-27

[4]
The Edinburgh CT and genetic diagnostic criteria for lobar intracerebral haemorrhage associated with cerebral amyloid angiopathy: model development and diagnostic test accuracy study.

Lancet Neurol. 2018-1-10

[5]
Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.

JAMA. 2017-12-19

[6]
Low-Dose Aspirin after an Episode of Haemorrhagic Stroke Is Associated with Improved Survival.

Thromb Haemost. 2017-12-6

[7]
Resumption of antiplatelet therapy in patients with primary intracranial hemorrhage-benefits and risks: A meta-analysis of cohort studies.

J Neurol Sci. 2017-11-10

[8]
Antiplatelet Resumption after Antiplatelet-Related Intracerebral Hemorrhage: A Retrospective Hospital-Based Study.

World Neurosurg. 2017-10

[9]
Antithrombotic treatment after stroke due to intracerebral haemorrhage.

Cochrane Database Syst Rev. 2017-5-25

[10]
Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study.

Trials. 2017-4-5

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