Start Or STop Anticoagulants Randomised Trial (SoSTART) Collaboration
For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage (ICrH) with permanent/persistent/paroxysmal atrial fibrillation (AF), it is unclear whether starting full treatment dose oral anticoagulation (OAC) is safe and results in a beneficial net reduction of all major vascular events compared with avoiding OAC. In this safety phase trial, we investigated whether the risk of recurrent spontaneous ICrH is sufficiently low after starting OAC (i.e. non-inferior to avoiding OAC) to justify a definitive trial.
SoSTART was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 67 hospitals in the UK. We recruited adults (≥18 years) who survived for 24 h after spontaneous ICrH, had AF, and CHA2DS2-VASc score ≥2. Computerised randomisation incorporating minimisation allocated participants (1:1) to avoid or start long-term (≥1 year) full treatment dose OAC (either a non-vitamin K antagonist direct oral anticoagulant [DOAC] or vitamin K antagonist if a DOAC could not be used, chosen by the patient’s physician before randomisation). We followed randomised participants for ≥1 year for a primary outcome of recurrent symptomatic spontaneous ICrH, and symptomatic serious vascular events as exploratory outcomes. We analysed outcomes using Cox proportional hazards regression adjusted for minimisation covariates, during all available follow-up. SoSTART is registered (NCT03153150).
The results will be available after database lock for a late-breaking presentation at the conference.
The effects of long-term OAC for AF after ICH will be determined by the COCROACH meta-analysis (PROSPERO 2021 CRD42021246133) of SoSTART and similar randomised trials (APACHE-AF [NCT02565693], NASPAF-ICH [NCT02998905], STATICH [NCT03186729], A3ICH [NCT03243175], ASPIRE [NCT03907046], ENRICH-AF [NCT03950076] & PRESTIGE-AF [NCT03996772]).
NCT03153150