ABSTRACT NUMBER: ESOC2026OT134 LACUNAR-TPA TRIAL (LACUNAR STROKE HYPERACUTE CLINICAL UTILIZATION OF NOVEL APPROACH REGIMENS: RT-PA VS. DAPT RANDOMISED CLINICAL TRIAL)

Abstract Background and aims In hyperacute lacunar stroke, the symptoms are usually mild, and the mechanism is not primarily embolic; therefore, the clinical benefit of intravenous rt-PA remains uncertain. Early dual antiplatelet therapy (DAPT) may reduce early neurological deterioration with a lower risk of bleeding, but evidence is limited. Methods To test whether DAPT is non-inferior to rt-PA for 90-day excellent functional outcomes and to compare their safety. Results LACUNAR-tPA (NCT07111559) is a multicenter (43 sites in Japan), randomized, open-label non-inferiority trial (n=500; 1:1). Adults aged ≥18 years presenting within 4.5 hours are eligible when MRI-DWI confirms a single perforator infarct ≤20 mm, with pre-stroke mRS ≤1, and NIHSS ≤5. Exclusion criteria include etiologies other than lacunar stroke. Randomization uses permuted blocks stratified by site and NIHSS (≤3 vs 4–5). In the DAPT arm, patients receive aspirin 200 mg plus clopidogrel 300 mg as loading doses, followed by aspirin 100 mg plus clopidogrel 75 mg daily for 14 days. In the rt-PA arm: alteplase 0.6 mg/kg (10% bolus, 90% infusion over 1 hour); no antithrombotics are given for 24 hours, followed by the same 14-day DAPT regimen. Conclusions Primary outcome is mRS 0–1 at 90 days (non-inferiority margin −5%). Key secondary outcomes include early neurological deterioration by day 7 (NIHSS increase ≥2), NIHSS at day 7, and recurrent stroke within 90 days. Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, other bleeding events, and mortality. Conflict of interest