Urokinase for Thrombolysis in Acute Ischemic Stroke

Prior treatment

• Having received heparin treatment within 24 h.
• Patients with planned or prior endovascular therapy.
• Participation in other clinical trials within 30 days before screening.

Other illness

• Unknown time of stroke onset.
• Pre-stroke mRS score ≥2.
• Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.).
• A history of intracranial hemorrhage.
• A history of severe head trauma or stroke within 3 months.
• A history of intracranial or spinal surgery within 3 months.
• A history of major surgery within 2 weeks.
• Severe liver impairment (e.g., liver failure, cirrhosis, portal hypertension \[esophageal varices\], active hepatitis).
• A history of gastrointestinal or urinary tract hemorrhage within 3 weeks.
• Active visceral bleeding.
• A history of arterial puncture at sites difficult for compression hemostasis within 1 week.
• Life expectancy \<1 year due to comorbid conditions.
• Uncontrollable hypertension upon active antihypertensive treatment: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg on ≥3 repeated measurements at 10-minute intervals.
• Subjects who are unable or unwilling to cooperate due to hemiplegia after epileptic seizure or other neurological/psychiatric disorders.
• Known to be allergic to urokinase.
• Other conditions deemed by the investigator to impair adherence or pose risks to participants.

Lab values

• Propensity for acute bleeding, including platelet count \<100 × 10⁹/L or otherwise.
• On oral anticoagulants (e.g., warfarin) with INR \>1.7 or PT \>15s.
• Blood glucose \<2.8 mmol/L or \>22.2 mmol/L.

Other

• Head CT or MRI shows a large infarction (infarcted area \>1/3 of the middle cerebral artery).
• NIHSS score 1A ≥2.
• Intracranial tumors, large intracranial aneurysms.
• Aortic dissection found.
• Bacterial endocarditis, pericarditis, or acute pancreatitis.
• Pregnancy, lactating women, or subjects who do not agree to use effective contraception during the trial.

• Age 18-80 years, male or female.
• Clinical diagnosis as ischemic stroke (the diagnosis following the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023).
• Time from onset to treatment \<6h; the time of symptom onset is defined as "the last time point at which the patient appears normal", and the symptoms of stroke persist for at least 30 minutes and show no significant improvement before treatment.
• NIHSS ≥1 at baseline.
• Subjects or their guardians voluntarily sign the informed consent.