The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: Study protocol for a randomised controlled trial

the RESTART collaborators

Research output: Contribution to journalArticle

11 Citations (Scopus)

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 drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs. Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study). Discussion: Final results of RESTART will be analysed and disseminated in 2019.

Original languageEnglish
Article number162
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - 5 Mar 2018
Externally publishedYes

Fingerprint

Platelet Aggregation Inhibitors
Cerebral Hemorrhage
Randomized Controlled Trials
Stroke
Magnetic Resonance Imaging
Random Allocation
Brain
Telephone
Sample Size
Anticoagulants
General Practitioners
Blood Vessels
Research Personnel
Therapeutics
Research

Keywords

  • Antiplatelet therapy
  • Intracerebral haemorrhage
  • Randomised controlled trial
  • Secondary prevention
  • Stroke

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage : Study protocol for a randomised controlled trial. / the RESTART collaborators.

In: Trials, Vol. 19, No. 1, 162, 05.03.2018.

Research output: Contribution to journalArticle

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title = "The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: Study protocol for a randomised controlled trial",
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 drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs. Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study). Discussion: Final results of RESTART will be analysed and disseminated in 2019.",
keywords = "Antiplatelet therapy, Intracerebral haemorrhage, Randomised controlled trial, Secondary prevention, Stroke",
author = "{the RESTART collaborators} and {Al-Shahi Salman}, Rustam and Dennis, {Martin S.} and Murray, {Gordon D.} and Karen Innes and Jonathan Drever and Lynn Dinsmore and Carol Williams and White, {Philip M.} and Whiteley, {William N.} and Sandercock, {Peter A.G.} and Sudlow, {Cathie L.M.} and Newby, {David E.} and Nikola Sprigg and Werring, {David J.} and Martin Dennis and Cathie Sudlow and William Whiteley and Christine Lerpiniere and Katrina McCormick and Jack Perry and Ruwan Parakramawansha and Neil Hunter and Fergus Doubal and Ruth Paulton and Richard O'Brien and Seona Burgess and Gillian Mead and Pat Taylor and MacLeod, {Mary Joan} and Beverly Maclennan and Rebecca Clarke and Vicky Taylor and Katrina Klaasen and Nichola Crouch and Baljit Jagpal and Jacqueline Furnace and Janice Irvine and Heather Gow and Anu Joyson and Sandra Nelson and Sarah Ross and Ruth Davies and Deepa Jose and Naomi Robinson and Laura Codd and Angela Dodd and Helen Moroney and Pauline Weir and Victoria Little and Law, {Zhe Kang}",
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AU - the RESTART collaborators

AU - Al-Shahi Salman, Rustam

AU - Dennis, Martin S.

AU - Murray, Gordon D.

AU - Innes, Karen

AU - Drever, Jonathan

AU - Dinsmore, Lynn

AU - Williams, Carol

AU - White, Philip M.

AU - Whiteley, William N.

AU - Sandercock, Peter A.G.

AU - Sudlow, Cathie L.M.

AU - Newby, David E.

AU - Sprigg, Nikola

AU - Werring, David J.

AU - Dennis, Martin

AU - Sudlow, Cathie

AU - Whiteley, William

AU - Lerpiniere, Christine

AU - McCormick, Katrina

AU - Perry, Jack

AU - Parakramawansha, Ruwan

AU - Hunter, Neil

AU - Doubal, Fergus

AU - Paulton, Ruth

AU - O'Brien, Richard

AU - Burgess, Seona

AU - Mead, Gillian

AU - Taylor, Pat

AU - MacLeod, Mary Joan

AU - Maclennan, Beverly

AU - Clarke, Rebecca

AU - Taylor, Vicky

AU - Klaasen, Katrina

AU - Crouch, Nichola

AU - Jagpal, Baljit

AU - Furnace, Jacqueline

AU - Irvine, Janice

AU - Gow, Heather

AU - Joyson, Anu

AU - Nelson, Sandra

AU - Ross, Sarah

AU - Davies, Ruth

AU - Jose, Deepa

AU - Robinson, Naomi

AU - Codd, Laura

AU - Dodd, Angela

AU - Moroney, Helen

AU - Weir, Pauline

AU - Little, Victoria

AU - Law, Zhe Kang

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AB - 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 drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs. Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study). Discussion: Final results of RESTART will be analysed and disseminated in 2019.

KW - Antiplatelet therapy

KW - Intracerebral haemorrhage

KW - Randomised controlled trial

KW - Secondary prevention

KW - Stroke

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