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

Recruiting now · Phase 4

Conditions studied: Lacunar Stroke, Stroke, Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT07111559

Run by

Nippon Medical School

People needed

500

Starts

2025-08-01

Expected to finish

2029-03-31

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Yamanashi Hospital — Chūō, Japan (enrolling)
• University of Fukui Hospital — Fukui, Japan (enrolling)
• Fukuoka Red Cross Hospital — Fukuoka, Japan (enrolling)
• Ota Memorial Hospital — Fukuyama, Japan (enrolling)
• Kansai Medical University Hospital — Hirakata, Japan (enrolling)
• Kagoshima City Hospital — Kagoshima, Japan (enrolling)
• Kagoshima Medical Center — Kagoshima, Japan (enrolling)
• Shioda Hospital — Katsuura, Japan (enrolling)
• St. Marianna University School of Medicine Hospital — Kawasaki, Japan (enrolling)
• The Jikei University West Medical Center — Komae, Japan (enrolling)
• Kawasaki Medical School Hospital — Kurashiki, Japan (enrolling)
• Japanese Red Cross Kyoto Daini Hospital — Kyoto, Japan (enrolling)
• University Hospital Kyoto Prefectural University of Medicine — Kyoto, Japan (enrolling)
• The Jikei University Hospital — Minatoku, Japan (enrolling)
• Kawasaki Medical School General Medical Center — Okayama, Japan (enrolling)
• National Cerebral and Cardiovascular Center — Osaka, Japan (enrolling)
• Kohnan Hospital — Sendai, Japan (enrolling)
• Jichi Medical University Hospital — Shimotsuke, Japan (enrolling)
• Nippon Medical School Tamanagayama hospital — Tama, Japan (enrolling)
• Dokkyo Medical University Hospital — Tochigi, Japan (enrolling)
• Tokushima University Hospital — Tokushima, Japan (enrolling)
• Juntendo University Hospital — Tokyo, Japan (enrolling)
• Nippon Medical School hospital — Tokyo, Japan (enrolling)
• Science Tokyo Hospital — Tokyo, Japan (enrolling)
• Tokyo Rosai Hospital — Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.