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

Launched by NIPPON MEDICAL SCHOOL · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat a type of small stroke called a lacunar stroke, which happens when tiny blood vessels in the brain get blocked. The researchers want to find out if taking a combination of two medicines that help prevent blood clots (called antiplatelet drugs) works as well as the current standard treatment, which is a medicine given through a vein called tissue plasminogen activator (or rt-PA) that helps dissolve clots. They also want to see if the combination of antiplatelet drugs causes fewer bleeding problems compared to rt-PA.

Adults who have just had a small stroke within the last 4.5 hours may be able to join, especially if their stroke shows up as a small, specific area of damage on a brain scan and they were able to live independently before the stroke. People with certain health conditions like active bleeding or who cannot take pills might not be eligible. Participants will receive either the combination of antiplatelet drugs or rt-PA, and then their recovery will be checked after three months, either in person, by phone, or by mail. This study is not yet recruiting, but it aims to help doctors find safer and effective treatments for small strokes in the future.

Gender

ALL

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 speech, 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 after the study was explained with the approved information sheet.
• Exclusion Criteria:
• • Antithrombotic therapy considered inappropriate because of active bleeding, low platelet count, or similar conditions.
• • Any contraindication to intravenous rt-PA.
• • ≥ 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 same examinations that each site normally performs before rt-PA administration.