Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke

Prior treatment

• Patients who have received prior reperfusion therapy outside the hospital (including intravenous thrombolysis and endovascular treatment).

Lab values

• Patients with absolute contraindications to reperfusion therapy (including intravenous thrombolysis and mechanical thrombectomy), specifically:
  • Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.) History of prior intracranial hemorrhage Severe head trauma or stroke within the past 3 months Intracranial tumor or giant intracranial aneurysm Intracranial or intraspinal surgery within the past 3 months Major surgical procedure within the past 2 weeks Gastrointestinal or urinary tract bleeding within the past 3 weeks Active visceral bleeding Aortic arch dissection Arterial puncture at a non-compressible site within the past 1 week 11 Elevated blood pressure: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg 12 Acute bleeding diathesis, including platelet count \< 100×10⁹/L or other conditions 13 Treatment with low molecular weight heparin within the past 24 hours 14 Oral anticoagulant use (warfarin) with INR \> 1.7 or PT \> 15 seconds 15 Use of thrombin inhibitors or factor Xa inhibitors within the past 48 hours, or abnormal laboratory tests deemed by the investigator to contraindicate thrombolysis (e.g., APTT, INR, platelet count, ECT, TT, or factor Xa activity assay) 16 Random blood glucose \< 2.8 mmol/L or \> 22.22 mmol/L 17 Head CT or MRI showing large-area infarction (infarct volume \> 1/3 of the middle cerebral artery territory)

Other

• Known pregnant or lactating female patients (judged by the investigator based on last menstrual period, medical history, or patient/family report).
• Patients expected to be unable to complete follow-up (e.g., predicted survival \< 3 months, or inability to comply with follow-up plans for other reasons).
• Patients participating in other clinical trials where the interventions may affect the results of this study.

• Adult patients aged 18 years or older.
• Time from symptom onset to treatment \< 4.5 hours, with the time of symptom onset defined as "last known normal time".
• Meet the diagnostic criteria for acute ischemic stroke, confirmed by imaging (head CT or MRI).
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≤ 25 points at admission.
• Planned to receive intravenous thrombolysis with either rhTNK-tPA (Mingfule®) 0.25 mg/kg or rt-PA (Actilyse®) 0.9 mg/kg.
• Voluntary signing of the informed consent form by the participant or their legal guardian.
• Have complete clinical and imaging data, and be able to cooperate with follow-up assessments.