At a glance
ClinicalIndex Comparison Record- ✓Age 18-80 years
- ✓Clinical diagnosis of ischemic stroke per Chinese Guidelines 2023
- ✓Time from symptom onset to treatment <6 hours
- ✓Symptoms persist ≥30 minutes with no significant improvement before treatment
- ✕Large infarction >1/3 of middle cerebral artery territory on imaging
- ✕Unknown time of stroke onset
- ✕Pre-stroke mRS score ≥2
- ✕NIHSS 1A score ≥2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Dose-Escalation Safety Study of Urokinase for Thrombolysis in Patients With Acute Ischemic Stroke
In Brief
A clinical study evaluating Urokinase thrombolysis for Acute Ischemic Stroke. Currently recruiting, targeting 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).