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

Exclusion Criteria20

• 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.
• Endovascular thrombectomy (EVT) planned at the time of randomization.
• Pre-stroke mRS≥2.
• Allergy to the test drug and its ingredients.
• Severe head trauma or ischemic stroke in the last 3 months.
• Intracranial or intraspinal surgery within 3 months before enrollment.
• Intracranial tumor or large-size aneurysm found before enrollment.
• Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
• Active visceral bleeding.
• Aortic arch dissection confirmed by examination or medical history.
• Infective endocarditis confirmed by examination or medical history.
• Platelet count less than 100 × 109 /L.
• Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
• Pregnant or lactating women.
• Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening.
• 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.
• Participating in other trials.
• 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.