Urokinase for Thrombolysis in Acute Ischemic Stroke

Launched by CAPITAL MEDICAL UNIVERSITY · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called urokinase, which is used to help dissolve blood clots in people who have had an acute ischemic stroke—a type of stroke caused by a blockage in the blood vessels of the brain. The goal is to find the safest and most effective dose of urokinase based on a person’s weight, to improve treatment outcomes and safety. Right now, doctors use different doses based on experience, but this study aims to create a clearer, weight-based dosing guide.

To take part, individuals need to be between 18 and 80 years old and have had an ischemic stroke within the past 6 hours. They also need to meet certain health criteria, like having a moderate level of stroke symptoms and no serious brain bleeding or other major health issues. Participants will receive urokinase through an IV and be closely monitored to see how well the treatment works and to ensure it’s safe. This study is not yet recruiting, but it hopes to help doctors provide better and more personalized stroke care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-80 years, male or female;
• • 2. Clinical diagnosis as ischemic stroke (the diagnosis following the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023);
• • 3. 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;
• • 4. 4 ≤ NIHSS ≤ 25 at baseline;
• • 5. Subjects or their guardians voluntarily sign the informed consent.
• Exclusion Criteria:
• • 1. Head CT or MRI shows a large infarction (infarcted area \> 1/3 of the middle cerebral artery);
• • 2. Unknown time of stroke onset;
• • 3. Pre-stroke mRS score ≥2;
• • 4. NIHSS score 1A ≥2;
• • 5. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
• • 6. A history of intracranial hemorrhage;
• • 7. Propensity for acute bleeding, including platelet count \<100 × 10⁹/L or otherwise;
• • 8. Having received heparin treatment within 24 h;
• • 9. On oral anticoagulants (e.g., warfarin) with INR\>1.7 or PT\>15s;
• • 10. Patients with planned or prior endovascular therapy;
• • 11. A history of severe head trauma or stroke within 3 months;
• • 12. Intracranial tumors, large intracranial aneurysms;
• • 13. A history of intracranial or spinal surgery within 3 months;
• • 14. A history of major surgery within 2 weeks;
• • 15. Severe liver impairment (e.g., liver failure, cirrhosis, portal hypertension \[esophageal varices\], active hepatitis);
• • 16. A history of gastrointestinal or urinary tract hemorrhage within 3 weeks;
• • 17. Active visceral bleeding;
• • 18. Aortic dissection found;
• • 19. A history of arterial puncture at sites difficult for compression hemostasis within 1 week;
• • 20. Life expectancy \<1 year due to comorbid conditions;
• • 21. 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);
• • 22. Blood glucose \<2.8 mmol/L or \>22.2 mmol/L;
• • 23. Subjects who are unable or unwilling to cooperate due to hemiplegia after epileptic seizure or other neurological/psychiatric disorders;
• • 24. Known to be allergic to urokinase;
• • 25. Bacterial endocarditis, pericarditis, or acute pancreatitis;
• • 26. Participation in other clinical trials within 30 days before screening;
• • 27. Pregnancy, lactating women, or subjects who do not agree to use effective contraception during the trial;
• • 28. Other conditions deemed by the investigator to impair adherence or pose risks to participants.