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

• Published in: Current controlled trials in cardiovascular medicine 2019-03, Vol.20 (1), p.183-8, Article 183
• Main Authors: Al-Shahi Salman, Rustam, Murray, Gordon D, Dennis, Martin S, Newby, David E, Sandercock, Peter A G, Sprigg, Nikola, Sudlow, Cathie L M, Werring, David J, White, Philip M, Whiteley, William N
• Format: Article
• Language: English
• Subjects: Analysis; Anticoagulants; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; antiplatelet therapy; Brain; Cerebral Hemorrhage - chemically induced; Cerebral Hemorrhage - diagnostic imaging; Cerebral Hemorrhage - drug therapy; Clinical trials; Consent; Data Interpretation, Statistical; Disease prevention; Drug Administration Schedule; Drug withdrawal; Drugs; Family physicians; Fibrinolytic agents; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - adverse effects; Health aspects; Hemorrhage; Humans; Hypotheses; Hypothesis testing; intracerebral haemorrhage; Magnetic resonance imaging; Medical imaging; Medical research; Neuroimaging; Observational studies; Patients; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Questionnaires; randomised controlled trial; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Secondary prevention; Secondary Prevention - methods; Secondary Prevention - statistics & numerical data; statistical analysis plan; Stroke; Stroke - chemically induced; Stroke - diagnostic imaging; Stroke - drug therapy; Stroke patients; Time Factors; Treatment Outcome; Update; Vascular diseases
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3270-2

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. 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. Final results of RESTART will be analysed and disseminated in May 2019. ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.