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RECRUITING
NCT07047326
NA

Urokinase for Thrombolysis in Acute Ischemic Stroke

Sponsor: Capital Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

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