Clot-Dissolving Drug rhPro-UK Before Stroke Clot Removal, Given Hours After Symptoms Begin
Tests rhPro-UK before thrombectomy in adults with stroke caused by a blocked large artery.
Plain-language title generated from the registry record
Registry title: Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND)
Key facts
- Where
- Beijing, Dalian, Lanzhou, Loudi, Shihezi, Shijiazhuang, Taiyuan, Xi'an, Xining, and Zhengzhou, ChinaSee the 10 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an acute stroke caused by a blocked large brain artery, who are first seen 4.5-24 hours after last known well and are planned for clot removal (thrombectomy).
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke, 4.5-24 hours after last known well, with a blocked large artery on CTA/MRA and a baseline NIHSS score of 6 or more. Brain scans must show a salvageable area (mismatch) for front-of-brain strokes, or a pc-ASPECTS score of 6 or more for back-of-brain strokes.
- Earlier treatment
- Before the stroke, people must have had little disability (mRS 2 or less if under 80 years, mRS 1 or less if 80 or older). They must plan to have endovascular thrombectomy. They cannot have had clot-dissolving drugs after this stroke.
Main reasons for not taking part
- Bleeding in the brain on CT/MRI, or a past bleed inside the skull
- Pregnant or breastfeeding women
- Active bleeding or a bleeding tendency
- Major surgery or injury recently (for example brain or spine surgery within 3 months)
- Life expectancy under 6 months
Read by machine on 9 November 2026.
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- The Second Hospital of Dalian Medical UniversityDalian, ChinaTaking people
- The First Hospital of Lanzhou UniversityLanzhou, ChinaTaking people
- Loudi Central HospitalLoudi, ChinaTaking people
- The First Affiliated Hospital of Shihezi UniversityShihezi, ChinaTaking people
- The Third Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Shanxi Cardiovascular HospitalTaiyuan, ChinaTaking people
- First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaTaking people
- Qinghai Provincial People's HospitalXining, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital Xi'an Jiaotong University
- Trial code
- NCT07389460
- Record updated
- 9 September 2026
- Original 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.Read full original descriptionShow less
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 )
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.
Inclusion: Age ≥18 years; Acute ischemic stroke presenting within 4.5-24 hours of last known well; No significant pre-stroke functional disability: for age <80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; Baseline NIHSS score ≥6; Imaging criteria of BOTH:; 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; Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent.
Exclusion: Already received intravenous thrombolytic after index stroke; History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma; Concurrent participation in other investigation clinical trials; Intracranial hemorrhage confirmed by CT/MRI; Onset accompanied by epileptic seizures, resulting in questionable stroke diagnosis and inability to obtain an accurate baseline NIHSS score; Active bleeding or bleeding tendency, such as gastrointestinal bleeding, urinary tract bleeding, retinal hemorrhage, etc., or presence of coagulation dysfunction; 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; Pre-existing neurological/psychiatric disorders interfering with neurological assessment; Terminal illness with life expectancy <6 months; Presence of other conditions deemed by the investigator as unsuitable for participation in the study; Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission; Baseline blood glucose <2.8 mmol/L or >22.2 mmol/L; 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; Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; Space-occupying intracranial tumors (except for small meningiomas); Intracranial aneurysm or arteriovenous malformation.