Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
NCT ID: NCT07111559
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2025-08-01
2029-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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rt-PA
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
DAPT
Dual antiplatelet therapy with aspirin 200mg and clopidogrel 300mg.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Japan Research Foundation for Clinical Pharmacology
UNKNOWN
Takeda Science Foundation - Medical Research Grant
UNKNOWN
Nippon Medical School
OTHER
Responsible Party
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Yuki Sakamoto
Associate Professor
Principal Investigators
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Yuki Sakamoto
Role: PRINCIPAL_INVESTIGATOR
Nippon Medical School
Locations
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University of Yamanashi Hospital
Chūō, , 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
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
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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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NMS-M-2024-210
Identifier Type: -
Identifier Source: org_study_id
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