Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND) (NCT07389460) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND)
China820 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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;
✕. Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission;
✕. Already received intravenous thrombolytic after index stroke;
✕. History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma;
What they're measuring
1
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
Timeframe: 90 days post-randomization
Trial details
NCT IDNCT07389460
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
✕. 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;
✕. Baseline blood glucose \<2.8 mmol/L or \>22.2 mmol/L;