Comparing Tissue Plasminogen Activator and Dual Antiplatelet Therapy for Treating Small Ischemic Stroke

What this Trial Is About

This clinical trial is studying adults who have experienced a small ischemic stroke, also known as lacunar stroke. It aims to determine if a combination of antiplatelet drugs dual antiplatelet therapy works as well as the standard treatment with intravenous tissue plasminogen activator rt-PA. Researchers also want to see if the combination reduces bleeding complications compared to rt-PA. Participants will be randomly assigned to receive either the dual antiplatelet therapy, which includes aspirin 200 mg and clopidogrel 300 mg, or intravenous rt-PA at a low dose of 0.6 mgkg alteplase, which is approved in Japan. The study follows a parallel design and is conducted at multiple centers. Treatment is given during the hyperacute phase within 4.5 hours of stroke onset. During the study, participants will be monitored for neurological status at 3 months after stroke through in-person visits, phone calls, or mail. Researchers will measure outcomes such as excellent recovery at 3 months, infarct growth, early neurological changes, stroke recurrence, and cost effectiveness. The total study period extends through March 2029, with primary outcome assessment at 3 months post-stroke.

Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial