NCT07111559

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

A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Nippon Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a combination of antiplatelet drugs works better than intravenous tissue plasminogen activator to treat small ischemic stroke (lacunar stroke). The main questions it aims to answer are: Is a combination of antiplatelet drugs non-inferior to the current standard tissue plasminogen activator treatment? Does a combination of antiplatelet drugs reduce the bleeding complications than tissue plasminogen activator? Researchers will compare a combination of antiplatelet drugs to tissue plasminogen activator to see if a combination of antiplatelet drugs works to treat small ischemic stroke (lacunar stroke). Participants will: Take a combination of antiplatelet drugs or be given intravenous tissue plasminogen activator Check the neurological status 3 months after stroke, in-person, by phone, or by mail.

Conditions

• Lacunar Stroke
• Stroke
• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	rt-PA	Recombinant tissue-plasminogen activator treatment. Low-dose (0.6mg/kg) alteplase will be given because this dosage is the only dosage approved in Japan.
DRUG	DAPT	Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2025-08-08
• Last updated: 2026-02-03

Locations

27 sites across 1 country: Japan