The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial.
Trials
; 20(1): 183, 2019 Mar 25.
Article
em En
| MEDLINE
| ID: mdl-30909946
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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Inibidores da Agregação Plaquetária
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Hemorragia Cerebral
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Acidente Vascular Cerebral
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Prevenção Secundária
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Fibrinolíticos
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article