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Taking people in JapanPhase 4

Compares two treatments for small ischemic strokes called lacunar stroke

Tests antiplatelet drugs against tissue plasminogen activator in adults with lacunar stroke.

Plain-language title generated from the registry record
Registry title: Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial

Key facts

Where
Chūō, Fukui, Fukuoka, Fukuyama, Hirakata, Kagoshima, Katsuura, Kawasaki, Komae, Kurashiki, Kyoto, Minatoku, Okayama, Osaka, Sendai, Shimotsuke, Tama, Tochigi, Tokushima, Tokyo, Ube, and Urayasu, JapanSee the 29 sites
Phase
Phase 4

Where in Japan

  • University of Yamanashi HospitalChūō, JapanTaking people
  • University of Fukui HospitalFukui, JapanTaking people
  • Fukuoka Red Cross HospitalFukuoka, JapanTaking people
  • Ota Memorial HospitalFukuyama, JapanTaking people
  • Kansai Medical University HospitalHirakata, JapanTaking people
  • Kagoshima City HospitalKagoshima, JapanTaking people
  • Kagoshima Medical CenterKagoshima, JapanTaking people
  • Shioda HospitalKatsuura, JapanTaking people
  • St. Marianna University School of Medicine HospitalKawasaki, JapanTaking people
  • The Jikei University West Medical CenterKomae, JapanTaking people
  • Kawasaki Medical School HospitalKurashiki, JapanTaking people
  • Japanese Red Cross Kyoto Daini HospitalKyoto, JapanTaking people
  • University Hospital Kyoto Prefectural University of MedicineKyoto, JapanTaking people
  • The Jikei University HospitalMinatoku, JapanTaking people
  • Kawasaki Medical School General Medical CenterOkayama, JapanTaking people
  • National Cerebral and Cardiovascular CenterOsaka, JapanTaking people
  • Kohnan HospitalSendai, JapanTaking people
  • Jichi Medical University HospitalShimotsuke, JapanTaking people
  • Nippon Medical School Tamanagayama hospitalTama, JapanTaking people
  • Dokkyo Medical University HospitalTochigi, JapanTaking people
  • Tokushima University HospitalTokushima, JapanTaking people
  • Juntendo University HospitalTokyo, JapanTaking people
  • Nippon Medical School HospitalTokyo, JapanTaking people
  • Science Tokyo HospitalTokyo, JapanTaking people
  • Tokyo Rosai HospitalTokyo, JapanTaking people
  • Tokyo Saiseikai Central HospitalTokyo, JapanTaking people
  • Tokyo Women's Medical University HospitalTokyo, JapanTaking people
  • Yamaguchi University HospitalUbe, JapanTaking people
  • Juntendo University Urayasu HospitalUrayasu, JapanTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Nippon Medical School
Trial code
NCT07111559
Record updated
4 August 2026
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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: ≥ 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) *; 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; Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions; Any contraindication to intravenous rt-PA, without blood pressures; Inability to take medicine orally.

ClinicalTrials.gov NCT07111559