NCT06194968

Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study

Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study (TASK-UK)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to to compare the safety and effectiveness of IV urokinase with IV alteplase in the treatment of AIS in patients up to 6 hours from symptom onset.

Detailed description

Recombinant tissue plasminogen activator (alteplase) is currently the recommended treatment of AIS in patients within 0 to 4.5 hours from symptom onset. The cost of a single treatment with this drug is around 5000 RMB (about 700 USD). In contrast, the cost of a single dose of urokinase is around 300 RMB (about 40 USD), making it much more affordable. Currently, existing evidence regarding the effectiveness and safety of urokinase is mixed. Some studies propose that urokinase thrombolysis, compared with alteplase thrombolysis, improves perfusion without increasing the incidence of adverse reactions and mortality. In some cases, using urokinase for thrombolysis even lowers the risk of systemic bleeding, comparing to alteplase. Other studies suggest that the effectiveness and safety of urokinase intreating AIS patients is infeiror comparing to alteplase . In this study, we plan to conduct a nationwide multicenter real-world study on urokinase intravenous thrombolysis with alteplase as an active control. We will observe and analyze AIS patients treated with urokinase and alteplase and compare the effectiveness, safety and economic effects. We will explore different urokinase dosage efficacy indicators and analyze relevant risk factors. This will provide data for future systematic evaluations of the clinical effects of urokinase thrombolysis which may help lower the medical costs in treating AIS while ensuring the effectiveness.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Urokinase	administered intravenously
DRUG	Alteplase	administered intravenously

Timeline

• Start date: 2023-12-30
• Primary completion: 2025-11-01
• Completion: 2026-12-01
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

16 sites across 1 country: China