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NCT07111559RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 4 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
500 (estimated)
First submitted
1 Aug 2025
Start date
1 Aug 2025
Primary completion date
31 Mar 2028
Lead sponsor
Nippon Medical School
Diseases
Stroke
NCT number
NCT07111559

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 500
  • From 1 Aug 2025 to the primary completion date, 31 Mar 2028
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • ≥ 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.

Lab values

  • Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions.

Other

  • Any contraindication to intravenous rt-PA, without blood pressures.
  • Inability to take medicine orally.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Yamanashi Hospital
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ChūōJapanRecruiting
University of Fukui Hospital
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FukuiJapanRecruiting
Fukuoka Red Cross Hospital
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FukuokaJapanRecruiting
Ota Memorial Hospital
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FukuyamaJapanRecruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
Kagoshima Medical Center
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KagoshimaJapanRecruiting
Kagoshima City Hospital
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KagoshimaJapanRecruiting
Shioda Hospital
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KatsuuraJapanRecruiting
St. Marianna University School of Medicine Hospital
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KawasakiJapanRecruiting
The Jikei University West Medical Center
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KomaeJapanRecruiting
Kawasaki Medical School Hospital
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KurashikiJapanRecruiting
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanRecruiting
Japanese Red Cross Kyoto Daini Hospital
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KyotoJapanRecruiting
The Jikei University Hospital
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MinatokuJapanRecruiting
Kawasaki Medical School General Medical Center
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OkayamaJapanRecruiting
National Cerebral and Cardiovascular Center
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OsakaJapanRecruiting
Kohnan Hospital
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SendaiJapanRecruiting
Jichi Medical University Hospital
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ShimotsukeJapanRecruiting
Nippon Medical School Tamanagayama hospital
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TamaJapanRecruiting
Dokkyo Medical University Hospital
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TochigiJapanRecruiting
Tokushima University Hospital
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TokushimaJapanRecruiting
Tokyo Rosai Hospital
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TokyoJapanRecruiting
Tokyo Saiseikai Central Hospital
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TokyoJapanRecruiting
Science Tokyo Hospital
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TokyoJapanRecruiting
Tokyo Women's Medical University Hospital
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TokyoJapanRecruiting
Juntendo University Hospital
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TokyoJapanRecruiting
Nippon Medical School Hospital
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TokyoJapanRecruiting
Yamaguchi University Hospital
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UbeJapanRecruiting
Juntendo University Urayasu Hospital
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UrayasuJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.