NCT05507645

ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE)

Recombinant Human Prourokinase（rhPro-UK）for Injection Versus Standard Medical Treatment for Acute Mild Ischemic Stroke (NIHSS≤5) Within 4.5 Hours After Symptom Onset

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,446 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.

Detailed description

After being informed about the study and potential risks, patients who meet the eligibility requirements will be randomized to recombinant human Prourokinase for injection (rhPro-UK) or standard medical treatment in a 1:1 ratio. Written informed consent will be needed.

Conditions

• Ischemic Stroke
• Mild
• Thrombosis

Interventions

Type	Name	Description
DRUG	Recombinant Human Prourokinase for Injection (rhPro-UK)	15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.
DRUG	standard medical treatment	Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-03-26
• Completion: 2024-06-17
• First posted: 2022-08-19
• Last updated: 2024-09-05

Locations

89 sites across 1 country: China