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Sponsor: Nippon Medical School
Conditions: Lacunar Stroke, Stroke, Ischemic Stroke
Interventions: rt-PA, DAPT
Countries: Japan
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Chūō, Japan
- Fukui, Japan
- Fukuoka, Japan
- Fukuyama, Japan
- Hirakata, Japan
- Kagoshima, Japan
- Kagoshima, Japan
- Katsuura, Japan
- Kawasaki, Japan
- Komae, Japan
- Kurashiki, Japan
- Kyoto, Japan
- Kyoto, Japan
- Minatoku, Japan
- Okayama, Japan
- Osaka, Japan
- Sendai, Japan
- Shimotsuke, Japan
- Tama, Japan
- Tochigi, Japan
- Tokushima, Japan
- Tokyo, Japan
- Tokyo, Japan
- Tokyo, Japan
- Tokyo, Japan
- Tokyo, Japan
- Tokyo, Japan
- Ube, Japan
- Urayasu, Japan