ABSTRACT NUMBER: ESOC2026A1846 TAILORED ANTIPLATELET SECONDARY PREVENTION IN NON-CARDIOEMBOLIC ISCHEMIC STROKE: A PHASE IV GENDER-STRATIFIED RANDOMIZED CONTROLLED TRIAL (TAILOR TRIAL) – STUDY DESIGN

Abstract Background and aims A substantial proportion of patients exhibit biological non-responsiveness to commonly used antiplatelet agents, which is associated with a markedly increased risk of early recurrence. The TAILOR trial aims to evaluate whether a tailored, platelet function–guided antiplatelet strategy improves short-term outcomes compared with usual care in patients with non-cardioembolic ischaemic stroke. Methods TAILOR is a phase IV, multicentre, pragmatic, open-label, gender-stratified, randomised controlled trial with blinded endpoint adjudication. Patients with recent non-cardioembolic ischaemic stroke requiring secondary prevention with antiplatelet therapy will be randomised 1:1 to either usual care or a tailored strategy guided by platelet aggregation testing. Following a 7–10-day run-in period, platelet function is assessed, and antiplatelet therapy is modified in the tailored arm in case of non-responsiveness. Participants are followed for 3 months. The primary endpoint is the 3-month cumulative incidence of a composite of recurrent ischaemic stroke, myocardial infarction, or cardiovascular death. Recruitment is planned to start in early 2026, with enrolment over 24 months across three Italian stroke centres. Results The trial is powered to detect a clinically meaningful reduction in the primary composite endpoint, assuming a decrease from 9% under usual care to 5% with tailored therapy. Interim safety and feasibility analyses are scheduled during recruitment. Study duration is 36 months. Final results are expected within six months after completion. Conclusions TAILOR will provide robust evidence on the effectiveness of a precision-medicine approach to antiplatelet secondary prevention after ischaemic stroke, with potential to reduce early cardiovascular events. Conflict of interest Andrea Zini: funding reveived by AIFA (Italian drug agency). Matteo Paolucci: nothing to disclose; Stefano Forlivesi: nothing to disclose; Giacomo Urbinati: nothing to disclose; Mauro Gentile: nothing to disclose; Francesca Rosafio: nothing to disclose; Laura Vandelli: nothing to disclose; Michele Romoli: nothing to disclose; Marco Longoni: nothing to disclose; Guido Bigliardi: nothing to disclose.