ABSTRACT NUMBER: ESOC2026LB160 INTRACRANIAL HAEMORRHAGE IN PATIENTS WITH NON-CARDIOEMBOLIC ISCHAEMIC STROKE OR HIGH-RISK TIA: INSIGHTS FROM THE OCEANIC-STROKE RANDOMISED TRIAL OF ASUNDEXIAN FOR SECONDARY STROKE PREVENTION

Abstract Background and aims In OCEANIC-STROKE, asundexian 50 mg once daily reduced ischaemic stroke (IS) compared with placebo (cause-specific HR [csHR], 0.74; 95% confidence interval [CI]: 0.65–0.84) without increasing intracranial haemorrhage (ICrH). We examined predictors and clinical severity of ICrH and haemorrhagic stroke (HS). Methods We randomised 12,327 participants within 72 h of acute non-cardioembolic IS or high-risk TIA to asundexian or placebo. This analysis includes 12,254 participants receiving ≥1 dose of assigned treatment. Incident ICrH were adjudicated by blinded adjudicators. ICrH outcome was assessed using the 90-day modified Rankin Scale (mRS); disabling ICrH or HS was defined as mRS ≥3 or increase of ≥1 point if baseline mRS ≥3. Site investigators determined whether ICrH or HS were the cause of death. Results With 1.2 years median follow-up, 74 ICrH occurred, including 33 HS. Annualised rates of ICrH were 0.5% for both asundexian and placebo (csHR, 1.07; 95% CI: 0.68–1.68), and, for HS, were 0.2% vs 0.3% (0.66; 0.33–1.32), respectively (Figure). Annualised rates of disabling ICrH were 0.3% for both (0.87; 0.46–1.63), and were 0.2% vs 0.1% (2.23; 0.78–6.42) for fatal ICrH. Corresponding rates for disabling (0.1% vs 0.2%; 0.68, 0.30–1.50) and fatal HS (0.1% vs 0.1%; 1.42, 0.45–4.46) were low and comparable between groups. Older age and Asian race independently predicted ICrH. Conclusions ICrH and HS were infrequent, with similar severity and outcomes between asundexian and placebo. Asundexian is a novel stroke prevention strategy that reduces IS without apparent increases in incident, disabling or fatal ICrH, including HS. Conflict of interest Figure 1 - belongs to Results