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NOT YET RECRUITING
NCT07389460
PHASE3

Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND)

Sponsor: First Affiliated Hospital Xi'an Jiaotong University

View on ClinicalTrials.gov

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

Interventions

DRUG

Intravenous rhPro-UK

Patients will receive intravenous rhPro-UK

DRUG

Intravenous placebo

Patients will receive intravenous placebo

PROCEDURE

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