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NCT07111559
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Conditions: Lacunar Stroke, Stroke, Ischemic Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 500
Sponsor: Nippon Medical School
Location: University of Yamanashi Hospital Chūō
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.
Source: ClinicalTrials.gov (NCT07111559). StuddyBuddy aggregates publicly available trial information.