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Urokinase for Thrombolysis in Acute Ischemic Stroke
Sponsor: Capital Medical University
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.
Official title: A Dose-Escalation Safety Study of Urokinase for Thrombolysis in Patients With Acute Ischemic Stroke
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-10-01
Completion Date
2027-01-02
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Urokinase thrombolysis
The intravenous thrombolysis group was administered urokinase dissolved in 100 mL of saline via continuous intravenous infusion for 30 min, and the treatment was given within 6 h of stroke onset. The dose escalation plan includes the following increments: 15,000 IU/kg (maximum dose: 1.5 million IU), 20,000 IU/kg (maximum dose: 2.0 million IU), 25,000 IU/kg (maximum dose: 2.5 million IU), and 30,000 IU/kg (maximum dose: 3.0 million IU).
Locations (1)
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China