Real-World Evaluation of Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours

Inclusion criteria

• Adults aged ≥18 years, regardless of sex.
• Pre-stroke modified Rankin Scale (mRS) score of 0-1.
• Patients with acute ischemic stroke treated within 4.5 hours of symptom onset, who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
• Written informed consent obtained from the participant or legally authorized representative.

Exclusion criteria

• Known severe hypersensitivity to recombinant human prourokinase.
• Other severe neurological, psychiatric, or systemic diseases that may interfere with outcome assessment, adherence, or follow-up.
• Uncontrolled severe hypertension before treatment (systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive therapy).
• Blood glucose <2.8 mmol/L or >22.2 mmol/L that remains uncontrolled after correction.
• Active internal bleeding or high bleeding risk, including gastrointestinal or urinary tract bleeding within 21 days, major surgery, severe trauma, major organ biopsy within 21 days, non-compressible arterial puncture within 7 days, or other significant bleeding risks.
• Known coagulation abnormalities or bleeding tendency, including platelet count <100 × 10⁹/L, INR >1.7, clinically significant PT prolongation, clinically significant APTT prolongation, or markedly decreased fibrinogen levels.
• Current or recent anticoagulant use associated with increased bleeding risk, including vitamin K antagonists with INR >1.7, direct thrombin inhibitors or factor Xa inhibitors within 48 hours with abnormal coagulation tests, or heparin within 24 hours with elevated APTT.
• History of ischemic stroke, severe head trauma, or myocardial infarction within 3 months.
• History of intracranial hemorrhage.
• Intracranial or spinal surgery within 3 months.
• Known intracranial neoplasm, arteriovenous malformation, large intracranial aneurysm, or other intracranial lesions associated with increased risk of intracranial hemorrhage.
• Baseline CT showing intracranial hemorrhage, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma.
• Extensive infarction or significant early ischemic changes on baseline imaging considered unsuitable for intravenous thrombolysis.
• Severe hepatic dysfunction, severe renal dysfunction, severe infection, active malignancy, terminal illness, or other serious conditions with expected survival <3 months.
• Pregnancy, breastfeeding, or positive pregnancy test in women of childbearing potential.
• Unable to complete 90-day follow-up, poor compliance, or other conditions considered unsuitable for study participation by the investigator.