ABSTRACT NUMBER: ESOC2026OT103 EARLY INITIATED AMBULANCE-DELIVERED LEVETIRACETAM AND HEADPOSITION IN HYPER-ACUTE STROKE TRIAL (EAST): PROTOCOL AND UPDATE

Abstract Background and aims Currently, there’s no efficient treatment in the ambulance for undifferentiated stroke patients. Timely, safe and efficient treatment strategies in the ambulance are urgently needed. Methods We initiated the Early initiated Ambulance-delivered levetiracetam and headposition in hyper-acute Stroke Trial (EAST) to determine the effectiveness and safety of prophylactic use of levetiracetam and lying flat position in patients with suspected acute stroke. Results A 2*2 factorial designed, multicentre, prospective, open-label, blinded endpoint, randomised controlled trial of pre-hospital initiated levetiracetam and headposition in 2423 presumed acute stroke patients at 50+ sites in China. Each participant will be randomised through a mobile phone digital system to levetiracetam vs standard management (Part A) and lying-flat vs sitting-up (30-60°) (Part B) at the same time. Levetiracetam will be used as intravenous injection, 500mg bolus in the ambulance and then 500mg twice daily orally after hospital arrival to 14 days (at least 7 days if discharged earlier) after randomisation. Ambulance and in-hospital data are collected over 14 days. Conclusions Primary outcome is a shift (improvement) in mRS scores at 90 days, analysed as an ordinal outcome. Conflict of interest