REstart or STop Antithrombotics Randomised Trial (RESTART) Collaboration
People surviving stroke due to intracerebral haemorrhage (ICH) are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely has been unclear. The RESTART trial involving survivors of ICH associated with antithrombotic therapy found that starting antiplatelet therapy seemed safe over a median 2·0 years of follow-up (12 [4%] of 268 participants allocated to antiplatelet therapy had recurrent ICH compared with 23 [9%] of 268 participants allocated to avoid antiplatelet therapy [adjusted hazard ratio 0·51 (95% CI 0·25–1·03); p=0·060]). However, the longer-term effects of antiplatelet therapy are uncertain.
RESTART was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet/anticoagulant) therapy for the prevention of occlusive vascular disease when they developed ICH, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. The main results of the trial reported follow-up for the primary outcome (recurrent ICH) and other major vascular events until November 2018. For these final results of RESTART, we continued follow-up of all randomised participants until November 2020 and analysed outcomes using Cox proportional hazards regression, adjusted for minimisation covariates using all available follow-up. RESTART is registered (ISRCTN71907627).
The results of extended follow-up will be available after database lock for a late-breaking presentation at the conference.
The effects of long-term antiplatelet therapy after ICH will be determined by RESTART and ongoing trials (STATICH [NCT03186729], RESTART-Fr [NCT02966119] & ASPIRING [NCT04522102]).
ISRCTN71907627