Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT07111559
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07111559
Study Brief:
Protocol Section:
NCT07111559