ABSTRACT NUMBER: ESOC2026OT11 LACUNAR INTERVENTION TRIAL 3 (LACI-3): EFFICACY AND SAFETY OF CILOSTAZOL AND ISOSORBIDE MONONITRATE TO PREVENT ADVERSE OUTCOMES IN SMALL VESSEL (LACUNAR) ISCHAEMIC STROKE

Abstract Background and aims A quarter of ischaemic strokes are lacunar, mostly due to intrinsic cerebral small vessel disease (SVD). There are no specific treatments to prevent adverse outcomes. Licensed drugs, isosorbide mononitrate (ISMN) and cilostazol have relevant effects and data. The LACunar Intervention Trial 1 (LACI-1) (n=57) and LACI-2 (n=363) confirmed trial feasibility, drug tolerability, and safety. Methods LACI-3 aims to determine whether long-term oral ISMN and/or cilostazol reduce cognitive impairment, stroke recurrence and other adverse outcomes after lacunar ischaemic stroke in a larger population. LACI-3 is being conducted with the UK Medicines and Healthcare products Regulatory Agency Scientific Advice to facilitate future licensing. Results LACI-3 is an investigator-led, Phase III, prospective, randomised, controlled, open label, blinded outcome, multicentre, 2x2 partial factorial trial. It aims to recruit 1300 participants from 55-60 UK centres, treated for 18-months, with overall trial duration 52 months. Patients with clinically-evident lacunar ischaemic stroke and compatible MR/CT are eligible. Interventions are oral ISMN (50mg OD or equivalent) and/or cilostazol (100mg BD), or neither. The study is funded by UK National Institute for Health and Care Research Health Technology Assessment. Conclusions The primary outcome is the 7-level DSM-5 cognitive score at 18 months. Secondary endpoints include dependency, recurrent stroke, mood, quality of life, individual cognitive test scores, safety and health economics. Conflict of interest