RecruitingPhase 4NCT07111559

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


Sponsor

Nippon Medical School

Enrollment

500 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called DAPT and a drug called rt-PA for people with ischemic stroke, lacunar stroke, and other related conditions. The study is currently recruiting participants at 28 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGrt-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.

DRUGDAPT

Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.


Locations(28)

University of Yamanashi Hospital

Chūō, Japan

University of Fukui Hospital

Fukui, Japan

Fukuoka Red Cross Hospital

Fukuoka, Japan

Ota Memorial Hospital

Fukuyama, Japan

Kansai Medical University Hospital

Hirakata, Japan

Kagoshima City Hospital

Kagoshima, Japan

Kagoshima Medical Center

Kagoshima, Japan

Shioda Hospital

Katsuura, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Japan

The Jikei University West Medical Center

Komae, Japan

Kawasaki Medical School Hospital

Kurashiki, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

The Jikei University Hospital

Minatoku, Japan

Kawasaki Medical School General Medical Center

Okayama, Japan

Kohnan Hospital

Sendai, Japan

Jichi Medical University Hospital

Shimotsuke, Japan

Nippon Medical School Tamanagayama hospital

Tama, Japan

Dokkyo Medical University Hospital

Tochigi, Japan

Tokushima University Hospital

Tokushima, Japan

Juntendo University Hospital

Tokyo, Japan

Nippon Medical School hospital

Tokyo, Japan

Science Tokyo Hospital

Tokyo, Japan

Tokyo Rosai Hospital

Tokyo, Japan

Tokyo Saiseikai Central Hospital

Tokyo, Japan

Tokyo Women's Medical University Hospital

Tokyo, Japan

Yamaguchi University Hospital

Ube, Japan

Juntendo University Urayasu Hospital

Urayasu, Japan

View Full Details on ClinicalTrials.gov

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