NCT07047326 Urokinase for Thrombolysis in Acute Ischemic Stroke
| NCT ID | NCT07047326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-10-01 with a primary completion date of 2026-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
According to the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke, intravenous thrombolysis with urokinase, administered at doses of 1-1.5 million IU within 6 hours of symptom onset, has been shown to be both safe and effective for patients with acute ischemic stroke. Compared to alteplase, urokinase offers considerable cost advantages while maintaining comparable therapeutic efficacy. However, current dosing protocols in clinical practice largely rely on the empirical judgment of physicians rather than evidence-based standardization. Therefore, the development of a weight-adjusted dosing regimen for urokinase is of significant clinical importance in optimizing treatment outcomes and ensuring patient safety. The purpose of this study is to determine the maximum tolerated dose of urokinase thrombolytic treatment in patients with acute ischemic stroke and to develop an optimal weight-adjusted dosing regimen.
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. NIHSS ≥1 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07047326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07047326 currently recruiting?
Yes, NCT07047326 is actively recruiting participants. Contact the research team at jixm@ccmu.edu.cn for enrollment information.
Where is the NCT07047326 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07047326 clinical trial?
NCT07047326 is sponsored by Capital Medical University. The trial plans to enroll 24 participants.
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