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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Yamanashi Hospital Coordinator of this site? Confirm its status | Chūō | Japan | Recruiting |
| University of Fukui Hospital Coordinator of this site? Confirm its status | Fukui | Japan | Recruiting |
| Fukuoka Red Cross Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Ota Memorial Hospital Coordinator of this site? Confirm its status | Fukuyama | Japan | Recruiting |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Recruiting |
| Kagoshima Medical Center Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Kagoshima City Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Shioda Hospital Coordinator of this site? Confirm its status | Katsuura | Japan | Recruiting |
| St. Marianna University School of Medicine Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| The Jikei University West Medical Center Coordinator of this site? Confirm its status | Komae | Japan | Recruiting |
| Kawasaki Medical School Hospital Coordinator of this site? Confirm its status | Kurashiki | Japan | Recruiting |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Japanese Red Cross Kyoto Daini Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| The Jikei University Hospital Coordinator of this site? Confirm its status | Minatoku | Japan | Recruiting |
| Kawasaki Medical School General Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| National Cerebral and Cardiovascular Center Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Kohnan Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuke | Japan | Recruiting |
| Nippon Medical School Tamanagayama hospital Coordinator of this site? Confirm its status | Tama | Japan | Recruiting |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Tochigi | Japan | Recruiting |
| Tokushima University Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Recruiting |
| Tokyo Rosai Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokyo Saiseikai Central Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Science Tokyo Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| Juntendo University Urayasu Hospital Coordinator of this site? Confirm its status | Urayasu | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.