TY - JOUR
T1 - The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage
T2 - Study protocol for a randomised controlled trial
AU - Al-Shahi Salman, Rustam
AU - Dennis, Martin
AU - Murray, Gordon D.
AU - Innes, Karen
AU - Drever, Jonathan
AU - Dinsmore, Lynn
AU - Williams, Carol
AU - White, Philip M.
AU - Whiteley, William
AU - Sandercock, Peter A.G.
AU - Sudlow, Cathie
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 - Gott, Valerie
AU - RESTART collaborators
N1 - Funding Information:
The British Heart Foundation funded RESTART via a special project grant (SP/ 12/2/29422) and a travel fellowship (FS/13/72/30531) paid to the University of Edinburgh. The British Heart Foundation funded PRIME via a project grant (PG/14/50/30891) paid to the University of Edinburgh.
PY - 2018/3
Y1 - 2018/3
N2 - 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.
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
UR - http://www.scopus.com/inward/record.url?scp=85043324274&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-2542-6
DO - 10.1186/s13063-018-2542-6
M3 - Article
C2 - 29506580
AN - SCOPUS:85043324274
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
M1 - 162
ER -