ABSTRACT NUMBER: ESOC2026LT72 LT72 - EARLY ANTIPLATELET THERAPY VERSUS LATE ANTIPLATELET THERAPY IN ACUTE ISCHEMIC STROKE PATIENTS WITH HEMORRHAGIC INFARCTION AFTER INTRAVENOUS THROMBOLYSIS (HITS): A RANDOMIZED CONTROLLED TRIAL

Abstract Background and aims Hemorrhagic infarction (HI) is the most common hemorrhagic transformation subtype after intravenous thrombolysis (IVT) for acute ischemic stroke (AIS), but optimal antiplatelet timing remains undefined. We aimed to determine whether early antiplatelet (EA) therapy improves functional outcomes without raising hemorrhagic risk. Methods In this randomised, multicenter, open-label, blinded-endpoint trial (HITS), patients were recruited from 41 stroke centres across China. AIS Patients were eligible if they treated with IVT within 24 hours of symptom onset, confirmed with HI on CT 24-36 hours post-IVT, and had no aspirin contraindications. Eligible patients were randomly assigned (1:1) to EA therapy (aspirin initiated within 24-48 hours post-IVT) or late antiplatelet (LA) therapy (antiplatelet therapy delayed beyond 48 hours after stroke onset). The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 days. Results Finally, 294 participants were randomly assigned to EA group (n=146) or LA group (n=148). The EA group had a significantly higher proportion of mRS 0-2 at 90 days (59.7% vs. 44.8%; adjusted risk ratio 1.259, 95% CI 1.005–1.580) compared with the LA group. No significant between-group differences were observed in 7-day symptomatic intracerebral hemorrhage, early neurological deterioration, hemorrhagic transformation expansion, or 90-day mortality. Recurrent acute ischemic stroke within 90 days occurred in 2 (1.4%) patients in both groups. Conclusions The HITS trial demonstrated that EA therapy initiated within 24-48 hours post IVT improves functional outcomes in post-IVT HI patient, without increasing hemorrhagic risk, providing definitive evidence to optimizing post-thrombolysis treatment. Conflict of interest