REstart or STop Antithrombotics Randomised Trial (RESTART) (2021)

RESTART tested whether antiplatelet therapy can be safely re-started in patients who have survived an intracerebral haemorrhage.

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RESTART logo

Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear.

RESTART aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events.

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RESTART recruited 537 participants between 22 May 2013 and 31 May 2018 from 122 hospitals across the UK.

The main results, based on follow-up of these participants until 30 November 2018, were published in 2019. The final results after two years of extended follow-up were published in 2021.

Trial dates

2013-2021

Trial team

Chief Investigator: Professor Rustam Al-Shahi Salman

Independent trial steering committee members: C Baigent (chairperson; University of Oxford, Oxford), D Lasserson (University of Birmingham, Birmingham), F Sullivan (University of St Andrews, St Andrews); J Carrie (patient–public representative; Edinburgh).
 
Other trial steering committee members: R Al-Shahi Salman, M S Dennis, G D Murray, D E Newby, P A G Sandercock, C L M Sudlow, W N Whiteley (University of Edinburgh, Edinburgh); N Sprigg (University of Nottingham, Nottingham); D J Werring (University College London, London); P M White (University of Newcastle-upon-Tyne, Newcastle-upon-Tyne).

Summary of findings

Extended follow-up, published 2021

Effects of Antiplatelet Therapy After Stroke Caused by Intracerebral Hemorrhage. JAMA Neurology 2021. doi:10.1001/jamaneurol.2021.2956

Video abstract

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Main results, published 2019

Main results: Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial. Lancet 2019. doi: 10.1016/S0140-6736(19)30840-2

 

Video abstract

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Sponsors

University of Edinburgh, NHS Lothian

Funders

British Heart Foundation

Registration

This trial was registered with ISRCTN (ISRCTN71907627).

Data sharing

Researchers can apply to access a fully anonymised RESTART dataset.