ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE)
NCT05507645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1446
Last updated 2024-09-05
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Yongjun Wang, MD · Beijing Tiantan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-15
- Primary Completion
- 2024-03-26
- Completion
- 2024-06-17
Countries
- China
Study Locations
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