OPTIMAS: A RANDOMISED CONTROLLED TRIAL TO ESTABLISH THE OPTIMAL TIMING OF ANTICOAGULATION AFTER ACUTE ISCHAEMIC STROKE

ABSTRACT

Background and aims: Atrial fibrillation (AF) causes at least one-fifth of ischaemic strokes, with a high risk of early recurrence. Oral anticoagulation is highly effective for reducing the long-term risk of recurrent ischaemic stroke in patients with AF. However, its benefit in the acute phase is unclear. OPTIMAS is an RCT aiming to establish the safety and efficacy of early anticoagulation with a direct oral anticoagulant (DOAC). Methods: OPTIMAS will enrol 3,478 participants with ischaemic stroke and AF from 100+ stroke services in the UK. Participants are randomised 11 to early (within 4 days) or standard (day 7 to 14 after stroke) initiation of anticoagulation. Follow-up is at 90 days, blinded to treatment allocation. The primary outcome is the incidence of stroke of any cause, and systemic arterial embolism. Results: OPTIMAS opened in June 2019 and is recruiting from 87 sites. 1,714 participants have been randomised. Recruitment and site-set up were reduced during the COVID-19 pandemic, due to national lockdowns and hospital staff being reallocated to COVID-related trials. We rapidly developed a contingency plan to face these challenges, implementing strategies, such as collecting the 90-day follow-ups and obtaining consents over the phone, and encouraging sites to sign up to the NIHR Associate PI Scheme to help with trial-related activities. The trial has consistently been recruiting 80+ patients per month. Conclusions: OPTIMAS will determine the efficacy and safety of early anticoagulation in patients with ischaemic strokes and AF. The trial is recruiting successfully despite COVID-19.