NCT07111559 Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
| NCT ID | NCT07111559 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nippon Medical School |
| Condition | Lacunar Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2025-08-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Yuki Sakamoto
PRINCIPAL INVESTIGATOR
Nippon Medical School
Frequently Asked Questions
Who can join the NCT07111559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lacunar Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07111559 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07111559 currently recruiting?
Yes, NCT07111559 is actively recruiting participants. Contact the research team at yuki-sakamoto@nms.ac.jp for enrollment information.
Where is the NCT07111559 trial being conducted?
This trial is being conducted at Chūō, Japan, Fukui, Japan, Fukuoka, Japan, Fukuyama, Japan and 11 additional locations.
Who is sponsoring the NCT07111559 clinical trial?
NCT07111559 is sponsored by Nippon Medical School. The principal investigator is Yuki Sakamoto at Nippon Medical School. The trial plans to enroll 500 participants.
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