A Phase 3 interventional study of Intravenous rhPro-UK and Intravenous placebo in Acute Ischemic Stroke, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 3, Interventional, and Treatment
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.
This multicenter, phase III trial employs a randomized, double-blind, placebo-controlled design to investigate the therapeutic window extension for rhPro-UK in large vessel occlusion stroke. Eligible participants are adults with large vessel occlusion confirmed by vascular imaging (CTA/MRA), and salvageable brain tissue demonstrated by perfusion imaging (CTP/MRP) mismatch. Exclusion criteria include contraindications to thrombolysis, and large core infarction (>70 mL on CTP).
Patients will be randomized 1:1 to receive either rhPro-UK or placebo, with a total dose of 35mg (15mg administered as an intravenous push within 5 minutes, followed by the remaining 20 mg continuously infused intravenously over 30 minutes) . All participants will undergo endovascular thrombectomy.
The primary outcome is functional independence (mRS 0-2) at 90 days. Secondary outcomes include substantial reperfusion at initial angiogram, first-pass reperfusion, final infarct volume on hour 36 CT, etc. Safety outcomes include symptomatic intracranial hemorrhage per Heidelberg Bleeding Classification criteria within 36 hours, and 90-day mortality.
Safety monitoring includes independent adjudication of hemorrhagic events and all-cause mortality. A sample size of 820 participants provides 80% power to detect a 10% absolute difference in functional independence (α=0.05).
The trial incorporates centralized blinded outcome assessment and intention-to-treat analysis, with data oversight by an independent clinical events committee and data safety monitoring board.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 820 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will be treated with intravenous rhPro-UK and endovascular thrombectomy
Drug: Intravenous rhPro-UK · Procedure: Endovascular thrombectomy
Patients in this group will be treated with intravenous placebo and endovascular thrombectomy
Drug: Intravenous placebo · Procedure: Endovascular thrombectomy
Patients will receive intravenous rhPro-UK
Also known as: Intravenous PUK, Intravenous recombinant human prourokinase
Patients will receive intravenous placebo
Also known as: Intravenous placebo (a visually identical substance without pharmacological activity)
Patients will receive endovascular thrombectomy
Also known as: Endovascular treatment, Mechanical thrombectomy
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days
The modified Rankin Scale (mRS) is employed to assess patients' activities of daily living and the degree of disability. It grades patients' functional ability on a scale from 0 to 6, with a score of 0 indicating no symptoms and 6 representing death. An mRS score of 0-2 indicates functional independence.
Time frame: 90 days post-randomization
Distribution of mRS scores at 90 days
The Modified Rankin Scale (mRS) is employed to assess patients' activities of daily living and the degree of disability. It grades patients' functional ability on a scale from 0 to 6, with a score of 0 indicating no symptoms and 6 representing death. The mRS score reflects the neurological functional status of stroke patients.
Time frame: 90 days post-randomization
Shift in mRS score at 90 days
The modified Rankin Scale (mRS) is employed to assess patients' activities of daily living and the degree of disability. It grades patients' functional ability on a scale from 0 to 6, with a score of 0 indicating no symptoms and 6 representing death. An mRS score shift reflects the improvement in the patient's neurological function.
Time frame: 90 days post-randomization
Proportion of excellent functional outcome (mRS score 0 to 1) at 90 days
The modified Rankin Scale (mRS) is employed to assess patients' activities of daily living and the degree of disability. It grades patients' functional ability on a scale from 0 to 6, with a score of 0 indicating no symptoms and 6 representing death. An mRS score of 0-1 indicates excellent functional outcome.
Time frame: 90 days post-randomization
Score on the EQ-5D-5L scale at 90 days
The EuroQoL 5-Dimension 5-Level (EQ-5D-5L) is a standardized health-related quality of life measurement instrument developed by the EuroQoL Group, primarily used to assess an individual's health status across multiple dimensions and their overall quality of life. The EQ-5D-5L describes an individual's health state based on five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort, and Anxiety/Depression. Scores range from 0, representing "the worst imaginable health," to 100, representing "the best imaginable health."
Time frame: 90 days post-randomization
Change in NIHSS score from baseline to 5-7 days post-procedure or at discharge
The National Institutes of Health Stroke Scale (NIHSS) is a tool designed for the rapid assessment of neurological deficit severity. Each item is scored from 0 to 4 based on the patient's performance, with a total score ranging from 0 to 42. A higher score indicates a more severe neurological deficit.
Time frame: 5-7 days post-procedure or at discharge
NIHSS score at 5-7 days post-procedure or at discharge
The National Institutes of Health Stroke Scale (NIHSS) is a tool designed for the rapid assessment of neurological deficit severity. Each item is scored from 0 to 4 based on the patient's performance, with a total score ranging from 0 to 42. A higher score indicates a more severe neurological deficit.
Time frame: 5-7 days post-procedure or at discharge
Final infarct volume on hour 36 NCCT
Infarct volume quantified via NCCT , with manual correction by certified radiologists.
Time frame: 36 hours post-randomization
Substantial reperfusion (defined as an eTICI grade of 2b50, 2b67, 2c, or 3) at initial angiogram
The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 7-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of \<50% of the territory; 2b50, a reperfusion of 50-66% of the territory; 2b67, a reperfusion of 67-89% of the territory;2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. Successful reperfusion at initial angiogram prior to thrombectomy was defined as an eTICI grade of 2b50, 2b67, 2c, or 3 on the first intracranial angiogram.
Time frame: within 5 minutes at initial angiogram
Successful reperfusion (defined as an eTICI grade of 2b, 2c, or 3) at end-of-procedure angiography
The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 7-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of \<50% of the territory; 2b50, a reperfusion of 50-66% of the territory; 2b67, a reperfusion of 67-89% of the territory;2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. This outcome will be evaluate at the end of procedure.
Time frame: 15 minutes after initial angiogram
Modified first-pass reperfusion
defined as Expanded Treatment in Cerebral Infarction 2b50, 2b67, 2c, or 3 after the first thrombectomy pass
Time frame: Perioperative (After artery puncture, but the start of procedure)
Time from arterial puncture to successful recanalization or final angiography
The time (in minutes) from arterial puncture to successful recanalization or the final angiogram, reflecting the duration of the procedure.
Time frame: Intraoperative
Proportion of balloon angioplasty or stent placement during endovascular treatment
Endovascular treatment includes procedures such as thrombectomy, balloon angioplasty, and stent placement. This outcome specifically focuses on the proportion of patients undergoing balloon angioplasty or stent placement during endovascular therapy.
Time frame: Intraoperative
Proportion of patients planned for but ultimately not receiving endovascular treatment
Patients planned for endovascular treatment may fail to undergo the procedure due to various reasons, including economic factors, disagreement among legal representatives, and changes in clinical condition, among others. This outcome focuses on the proportion of patients who were scheduled to receive but ultimately did not undergo endovascular treatment.
Time frame: Perioperative (After artery puncture, but the start of procedure)
Symptomatic intracranial hemorrhage within 36 hours
evaluate intracranial hemorrhage (Heidelberg classification)
Time frame: within 36 hours after endovascular treatment
Proportion of patients with parenchymal hematoma at 36 hours post-procedure
European Cooperative Acute Stroke Study (ECASS) classification: Hemorrhagic infarction (HI) is divided into: HI1: Small petechial hemorrhages along the margins of the infarct. HI2: Confluent or multiple scattered petechial hemorrhages within the infarcted area. Parenchymal hematoma (PH) is divided into: PH1: Hematoma occupying ≤30% of the infarcted area, with mild mass effect. PH2: Hematoma occupying \>30% of the infarcted area, with significant mass effect. This outcome will be evaluate the proportion of patients with PH2-type (parenchymal hematoma type 2) at 36 hours postoperatively.
Time frame: within 36 hours after endovascular treatment
Mortality within 90 days
evaluate death rate of the two treatment groups
Time frame: 90 days post-randomization
Procedural-related complications
evaluate complications
Time frame: within 90 days
Severe adverse events
evaluate any adverse events
Time frame: within 90 days
Plan to share: Yes — study data without patient information
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Related papers published 6 months later, the IPD will be shared
Access criteria: rabbit1110@163.com
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