RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: First Affiliated Hospital Xi'an Jiaotong University • ClinicalTrials.gov ID: NCT07389460

Registry updated: 2026-09-09

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Intravenous rhPro-UK (Drug)
Patients will receive intravenous rhPro-UK
Intravenous placebo (Drug)
Patients will receive intravenous placebo
Endovascular thrombectomy (Procedure)
Patients will receive endovascular thrombectomy

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years; 2. Acute ischemic stroke presenting within 4.5-24 hours of last known well; 3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. Baseline NIHSS score ≥6; 5. Imaging criteria of BOTH: 1\. Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6. 6\. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT/MRI; 2. Onset accompanied by epileptic seizures, resulting in questionable stroke diagnosis and inability to obtain an accurate baseline NIHSS score; 3. Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission; 4. Already received intravenous thrombolytic after index stroke; 5. History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma; 6. Active bleeding or bleeding tendency, such as gastrointestinal bleeding, urinary tract bleeding, retinal hemorrhage, etc., or presence of coagulation dysfunction; 7. History of major recent surgery or trauma, such as intracranial or spinal surgery within the past 3 months, major surgery within the past 2 weeks, or severe head trauma within the past 3 weeks; 8. Baseline blood glucose \<2.8 mmol/L or \>22.2 mmol/L; 9. Received low molecular weight heparin within 24 hours, or oral anticoagulants with an International Normalized Ratio (INR) \>1.7, or thrombin inhibitors within 48 hours, among others; 10. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; 11. Pre-existing neurological/psychiatric disorders interfering with neurological assessment; 12. Space-occupying intracranial tumors (except for small meningiomas); 13. Intracranial aneurysm or arteriovenous malformation; 14. Terminal illness with life expectancy \<6 months; 15. Concurrent participation in other investigation clinical trials; 16. Presence of other conditions deemed by the investigator as unsuitable for participation in the study.

Conditions

Acute Ischemic Stroke

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment