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Clinical Trials in Japan / NCT07111559
Recruiting Phase 4

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

NCT07111559 · tracked via the Priya Life Science Japan tracker
Sponsor
Nippon Medical School
Phase
Phase 4
Started
2025-08-01
Last updated
2026-08-04

Condition(s) studied

Lacunar StrokeStrokeIschemic Stroke

Investigational drug(s) / intervention(s)

rt-PA →DAPT →

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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years. * Acute ischemic stroke within 4.5 hours from onset. If onset time is unknown because of impaired consciousness or aphasia, use the "last known well" time. * A single perforating-artery infarct on brain MRI: located in the corona radiata, putamen, internal capsule, thalamus, or pons; solitary, mainly round or oval, with a maximum diameter ≤ 20 mm; lesions only in the centrum semiovale are not allowed, but extension from the above sites into the centrum semiovale is allowed. * No disability in daily life before the stroke (modified Rankin Scale ≤ 1). * National Institutes of Health Stroke Scale (NIHSS) score ≤ 5. * Written informed consent obtained. Exclusion Criteria: * Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions. * Any contraindication to intravenous rt-PA, without blood pressures. * ≥ 50 % stenosis or occlusion of the artery responsible for the stroke \* (see note below). * Diseases that require anticoagulation (e.g., atrial fibrillation, deep-vein thrombosis) \* * Inability to take medicine orally. * Any other reason judged by the principal investigator or co-investigators to make participation inappropriate. Note: This study targets hyper-acute stroke within 4.5 hours. To avoid treatment delay, items marked with \* must be judged using the similar examinations that each site normally performs before rt-PA administration.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
University of Yamanashi Hospital Chūō Japan Recruiting
University of Fukui Hospital Fukui Japan Recruiting
Fukuoka Red Cross Hospital Fukuoka Japan Recruiting
Ota Memorial Hospital Fukuyama Japan Recruiting
Kansai Medical University Hospital Hirakata Japan Recruiting
Kagoshima City Hospital Kagoshima Japan Recruiting
Kagoshima Medical Center Kagoshima Japan Recruiting
Shioda Hospital Katsuura Japan Recruiting
St. Marianna University School of Medicine Hospital Kawasaki Japan Recruiting
The Jikei University West Medical Center Komae Japan Recruiting
Kawasaki Medical School Hospital Kurashiki Japan Recruiting
Japanese Red Cross Kyoto Daini Hospital Kyoto Japan Recruiting
University Hospital Kyoto Prefectural University of Medicine Kyoto Japan Recruiting
The Jikei University Hospital Minatoku Japan Recruiting
Kawasaki Medical School General Medical Center Okayama Japan Recruiting
National Cerebral and Cardiovascular Center Osaka Japan Recruiting
Kohnan Hospital Sendai Japan Recruiting
Jichi Medical University Hospital Shimotsuke Japan Recruiting
Nippon Medical School Tamanagayama hospital Tama Japan Recruiting
Dokkyo Medical University Hospital Tochigi Japan Recruiting
Tokushima University Hospital Tokushima Japan Recruiting
Juntendo University Hospital Tokyo Japan Recruiting
Nippon Medical School hospital Tokyo Japan Recruiting
Science Tokyo Hospital Tokyo Japan Recruiting
Tokyo Rosai Hospital Tokyo Japan Recruiting
Tokyo Saiseikai Central Hospital Tokyo Japan Recruiting
Tokyo Women's Medical University Hospital Tokyo Japan Recruiting
Yamaguchi University Hospital Ube Japan Recruiting
Juntendo University Urayasu Hospital Urayasu Japan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07111559 on ClinicalTrials.gov ↗ ← All trials in Japan