ABSTRACT NUMBER: ESOC2026OT166 SAFETY AND EFFICACY OF EARLY ASPIRIN ADMINISTRATION AFTER INTRAVENOUS THROMBOLYSIS FOR ACUTE ISCHEMIC STROKE (TREND-IVT): A MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL

Abstract Background and aims Early neurological deterioration after intravenous thrombolysis (IVT) occurs frequently in patients with acute ischemic stroke (AIS) and is associated with poor functional outcomes. Whether early initiation of antiplatelet therapy after IVT can improve recovery without increasing bleeding risk remains uncertain. Methods To evaluate the safety and efficacy of administering 300 mg aspirin within 3 hours after initiation of IVT compared with delayed, guideline-recommended antiplatelet therapy in patients with AIS. Results This is a multicenter, randomized, placebo-controlled trial conducted in China. Patients with AIS treated with IVT (alteplase or tenecteplase) and not scheduled for endovascular therapy are eligible. Participants are randomized in a 1:1 ratio to receive either early aspirin or placebo within 3 hours after IVT initiation. In both groups, guideline-recommended standard antiplatelet therapy is initiated 24 hours after IVT. Conclusions The primary outcome is excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days. Secondary outcomes include mRS 0–2 and ordinal shift analysis of mRS scores at 90 days. Safety outcomes include symptomatic intracerebral hemorrhage, any intracerebral hemorrhage within 48 hours, systemic bleeding, recurrent stroke, other vascular events, mortality, and other adverse events during the 90-day follow-up. Conflict of interest