Abstract Number: Esoc2026ot112 the Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa Inhibitors Trial (Sift)

Background and aims Intravenous thrombolysis (IVT) is an effective treatment for disabling acute ischemic stroke (AIS) when administered within 4.5 hours of symptom onset. Patients with recent ingestion of factor Xa (FXa) inhibitors (within the last 48 hours) are currently excluded from IVT in existing guidelines due to concerns about hemorrhagic complications. However, observational studies suggest that IVT may be both safe and effective in this patient group, highlighting the need for randomized controlled trials. Methods To evaluate the efficacy and safety of IVT in AIS patients with recent ingestion (last 48 hours) of an FXa inhibitor who are otherwise eligible for IVT. Results This is a pragmatic, multicenter, phase III, randomized, open-label, blinded-endpoint (PROBE) trial. Patients with disabling AIS receiving FXa inhibitor are randomized in a 2:1 ratio to IVT or standard care without IVT. The primary endpoint, early neurological improvement (ENI), is analyzed using logistic regression adjusted for age, baseline National Institutes of Health Stroke Scale (NIHSS) score, and time to treatment. Safety is continuously monitored, with predefined early stopping rules for symptomatic intracranial hemorrhage (sICH). Conclusions The primary outcome is ENI, defined as a reduction of ≥8 points on the NIHSS or an NIHSS score of 0–1 at 24 hours (22-36h). Secondary outcomes include neurological improvement, infarct volume, any ICH, sICH, functional outcome assessed by the modified Rankin Scale at 90 days and mortality. Conflict of interest