NCT07389460

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
820

participants targeted

Target at P75+ for phase_3

Timeline
23mo left

Started Jan 2026

Geographic Reach
1 country

10 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

January 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 27, 2026

Last Update Submit

February 4, 2026

Conditions

Acute Ischemic Stroke

Keywords

Large Vessel Occlusion StrokeRecombinant Human ProurokinaseExtended Time WindowIntravenous Thrombolytic TherapyEndovascular Treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days post-randomization

Secondary Outcomes (18)

  • Distribution of mRS scores at 90 days

    90 days post-randomization

  • Shift in mRS score at 90 days

    90 days post-randomization

  • Proportion of excellent functional outcome (mRS score 0 to 1) at 90 days

    90 days post-randomization

  • Score on the EQ-5D-5L scale at 90 days

    90 days post-randomization

  • Change in NIHSS score from baseline to 5-7 days post-procedure or at discharge

    5-7 days post-procedure or at discharge

  • +13 more secondary outcomes

Study Arms (2)

rhPro-UK group

EXPERIMENTAL

Patients in this group will be treated with intravenous rhPro-UK and endovascular thrombectomy

Drug: Intravenous rhPro-UKProcedure: Endovascular thrombectomy

Placebo group

PLACEBO COMPARATOR

Patients in this group will be treated with intravenous placebo and endovascular thrombectomy

Drug: Intravenous placeboProcedure: Endovascular thrombectomy

Interventions

Intravenous placeboDRUG

Patients will receive intravenous placebo

Also known as: Intravenous placebo (a visually identical substance without pharmacological activity)
Placebo group
Endovascular thrombectomyPROCEDURE

Patients will receive endovascular thrombectomy

Also known as: Endovascular treatment, Mechanical thrombectomy
Placebo grouprhPro-UK group
Intravenous rhPro-UKDRUG

Patients will receive intravenous rhPro-UK

Also known as: Intravenous PUK, Intravenous recombinant human prourokinase
rhPro-UK group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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;
  • 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;
  • Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
  • Space-occupying intracranial tumors (except for small meningiomas);
  • Intracranial aneurysm or arteriovenous malformation;
  • Terminal illness with life expectancy \<6 months;
  • Concurrent participation in other investigation clinical trials;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Loudi Central Hospital

Loudi, Hunan, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Qinghai Provincial People's Hospital

Xining, Qinghai, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Location

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang Uygur Autonomous Region, China

Location

Xuanwu Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Fude Liu, MD

CONTACT

18161823657liufude101@163.com

Yawen Cheng, MD

CONTACT

13572255252alicia_cheng@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 5, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

study data without patient information

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Related papers published 6 months later, the IPD will be shared
Access Criteria
rabbit1110@163.com

Locations

CN(10)