drugset / Trial / NCT07047326

Urokinase for Thrombolysis in Acute Ischemic Stroke

NCT07047326

Recruiting 24 enrolled Capital Medical University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-01
Primary completion
2026-10-02
Completion
2027-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Urokinase Protein / enzyme biologic 15000 iu/kg Intravenous
Subject Urokinase Protein / enzyme biologic 20000 iu/kg Intravenous
Subject Urokinase Protein / enzyme biologic 25000 iu/kg Intravenous
Subject Urokinase Protein / enzyme biologic 30000 iu/kg Intravenous

Indications