rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window

Ki vehet részt

• Age 18 years or older
• Presumed acute ischemic stroke of the anterior circulation
• Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive)
• Limited early ischemic changes on non-contrast CT (NCCT)
• Written informed consent signed by patients or their legally authorized representatives

Ki nem vehet részt

• Intracranial or intraspinal surgery within 3 months before enrollment
• Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment
• Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator
• Intracranial or subarachnoid hemorrhage identified on baseline NCCT
• Pre-stroke mRS≥2
• Allergy to the test drug and its ingredients
• Severe head trauma or ischemic stroke in the last 3 months
• Gastrointestinal or urinary system hemorrhage within the past 3 weeks
• Active visceral bleeding
• Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management
• Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness
• Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder
• Platelet count less than 100 × 109 /L
• Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening
• Endovascular thrombectomy (EVT) planned at the time of randomization
• Intracranial tumor or large-size aneurysm found before enrollment
• Aortic arch dissection confirmed by examination or medical history
• Infective endocarditis confirmed by examination or medical history
• Pregnant or lactating women
• Participating in other trials