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

Al-Shahi Salman, R. et al. (2018) The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial. Trials, 19, 162. (doi: 10.1186/s13063-018-2542-6) (PMID:29506580) (PMCID:PMC5838871)

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. Trial registration: ISRCTN71907627 (www.isrctn.com/ISRCTN71907627). Prospectively registered on 25 April 2013.

• Item Type: Articles
• Additional 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.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Huang, Dr Xuya and Elliot, Dr Jennifer and Langhorne, Professor Peter and Kerr, Dr Gillian and Newby, Professor David and Moreton, Dr Fiona and Ramachandran, Dr Sankaranarayana and Cheripelli, Dr Bharath Kumar and El Tawil, Dr Salwa and Muir, Professor Keith and Smith, Mrs Wilma and Kalladka, Dr Dheeraj and McAlpine, Dr Christine
• Authors: Al-Shahi Salman, R., Dennis, M. S., Murray, G. D., Innes, K., Drever, J., Dinsmore, L., Williams, C., White, P. M., Whiteley, W. N., Sandercock, P. A. G., Sudlow, C. L. M., Newby, D. E., Sprigg, N., Werring, D. J., Langhorne, P., McAlpine, C., Kerr, G., Muir, K., Kalladka, D., Smith, W., Moreton, F., Cheripelli, B. K., Huang, X., El Tawil, S., Ramachandran, S., and Elliot, J.
• College/School: College of Medical Veterinary and Life Sciences; College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Psychology & Neuroscience; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2018 The Authors
• First Published: First published in Trials 19: 162
• Publisher Policy: Reproduced under a Creative Commons License