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Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND)
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Summary
This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human Prourokinase (rhPro-UK) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhPro-UK enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhPro-UK increases the risk of symptomatic intracranial hemorrhage and mortality. Participants will be randomized to receive an intravenous bolus of rhPro-UK or matching placebo, with a total dose of 35mg (15mg administered as an intravenous push within 5 minutes, and the remaining 20mg continuously infused intravenously over 30 minutes). Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.
Official title: Intravenous rhPro-UK Versus Placebo Before Endovascular Thrombectomy For Stroke Patient With Large Vessel Occlusion In The Extended Time Window: the Randomized, Placebo-controlled, Double-blind Trial (BRIDGE-PUK EXTEND )
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
820
Start Date
2026-01-31
Completion Date
2028-03-31
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
Intravenous rhPro-UK
Patients will receive intravenous rhPro-UK
Intravenous placebo
Patients will receive intravenous placebo
Endovascular thrombectomy
Patients will receive endovascular thrombectomy
Locations (10)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Loudi Central Hospital
Loudi, Hunan, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang Uygur Autonomous Region, China
Xuanwu Hospital Capital Medical University
Beijing, China