Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke

NCT07776873 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY2026-08-72(1)
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

Brief Summary

The HOPE-MeVO study aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke due to medium vessel occlusion presenting 4.5 to 24 hours after stroke onset or last known well. Eligible patients will be selected based on CT perfusion imaging and randomly assigned to receive rhPro-UK plus standard medical treatment or standard medical treatment alone. The primary objective is to determine whether rhPro-UK improves functional outcome at 90 days.

Conditions

Acute Ischemic Stroke

Keywords

Medium Vessel Occlusion; Recombinant Human Prourokinase; Late-Window Intravenous Thrombolysis

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With a Modified Rankin Scale Score of 0-1

  Excellent functional outcome is defined as a modified Rankin Scale (mRS) score of 0-1. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating less disability.

  90 days after randomization (±7 days)

Secondary Outcomes (10)

• Distribution of Modified Rankin Scale Scores

  90 days after randomization (±7 days)

• Proportion of Participants With a Modified Rankin Scale Score of 0-2

  90 days after randomization (±7 days)

• Proportion of Participants With Successful Recanalization of the Target Vessel

  24 hours after randomization (-2/+12 hours)

• Proportion of Participants With Imaging Reperfusion

  24 hours after randomization (-2/+12 hours)

• Infarct Volume Growth

  24 hours after randomization (-2/+12 hours)

Other Outcomes (8)

• Proportion of Participants With Symptomatic Intracranial Hemorrhage According to the SITS-MOST Criteria

  Within 36 hours after randomization

• Proportion of Participants With Symptomatic Intracranial Hemorrhage According to the ECASS III Criteria

  Within 36 hours after randomization

• Proportion of Participants With Symptomatic Intracranial Hemorrhage According to the Heidelberg Bleeding Classification

  Within 36 hours after randomization

Study Arms (2)

Recombinant Human Prourokinase Group

EXPERIMENTAL

Participants assigned to this group will receive intravenous recombinant human prourokinase (rhPro-UK) in addition to standard medical treatment.

Drug: Recombinant Human Prourokinase for Injection (rhPro-UK); Other: Standard medical treatment (SMT)

Standard Medical Treatment Group

ACTIVE COMPARATOR

Participants assigned to this group will receive standard medical treatment alone.

Other: Standard medical treatment (SMT)

Interventions

Standard medical treatment (SMT) OTHER

Standard medical treatment is individualized according to the 2026 AHA/ASA Guideline for the Early Management of Patients With Acute Ischemic Stroke.

Recombinant Human Prourokinase Group; Standard Medical Treatment Group

Recombinant Human Prourokinase for Injection (rhPro-UK) DRUG

Recombinant human prourokinase (rhPro-UK) is administered intravenously at a fixed total dose of 35 mg: a 15 mg intravenous bolus over 3 minutes, followed by a 20 mg intravenous infusion over 30 minutes.

Recombinant Human Prourokinase Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Pre-stroke modified Rankin Scale (mRS) score of 0-1.
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6, or an NIHSS score of 4-5 with a disabling neurological deficit, including but not limited to hemianopia, aphasia, or impaired hand motor function.
• Time from last known well of 4.5 to 24 hours, including wake-up stroke or unwitnessed stroke. Symptom onset is defined as the last time the participant was known to be well.
• Primary medium vessel occlusion confirmed by computed tomography angiography (CTA), involving the M2, M3, or M4 segment of the middle cerebral artery (MCA); the A1, A2, A3, or A4 segment of the anterior cerebral artery (ACA); or the P1, P2, P3, or P4 segment of the posterior cerebral artery (PCA), and identified as the responsible vessel for the signs and symptoms of acute ischemic stroke.
• Perfusion mismatch on computed tomography perfusion (CTP), defined as an infarct core volume \<50 mL, a hypoperfused volume/infarct core volume ratio ≥1.2, and a hypoperfused volume minus infarct core volume ≥10 mL. The infarct core is defined as tissue with relative cerebral blood flow (rCBF) \<30%, and the hypoperfused region as tissue with Tmax \>6 seconds.
• Written informed consent provided by the participant or the participant's legally authorized representative.

You may not qualify if:

• Planned direct endovascular treatment (EVT).
• Known history of severe hypersensitivity to recombinant human prourokinase, human albumin, mannitol, iodinated contrast media, or medications used for study-related examinations or treatment.
• Rapidly improving clinical symptoms such that, in the investigator's judgment, the participant is not suitable for the study intervention.
• Seizure at stroke onset when, in the investigator's judgment, the neurological deficit may be attributable to postictal Todd paralysis or another non-ischemic cause.
• Other severe neurological, psychiatric, or systemic disease that may substantially affect efficacy assessment, compliance, or completion of follow-up.
• Persistent severe hypertension that cannot be adequately controlled with medication, defined as systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg before treatment and remaining uncontrolled after antihypertensive treatment.
• Blood glucose \<2.8 mmol/L or \>22.2 mmol/L and, after appropriate treatment, the participant remains unsuitable for enrollment.
• Active internal bleeding or a condition associated with a high risk of bleeding, including but not limited to gastrointestinal or urinary tract bleeding within the previous 21 days; major surgery, severe trauma, or biopsy of a major organ within the previous 21 days; arterial puncture at a noncompressible site within the previous 7 days; or any other condition considered by the investigator to confer a substantial bleeding risk.
• Known coagulation abnormality or bleeding tendency, including but not limited to platelet count \<100 × 10\^9/L, international normalized ratio (INR) \>1.7, markedly prolonged prothrombin time (PT), activated partial thromboplastin time (APTT) above the upper limit of normal and considered clinically significant, or markedly reduced fibrinogen level.
• Current or recent use of anticoagulant therapy associated with an increased thrombolysis-related bleeding risk, including use of a vitamin K antagonist with INR \>1.7; use of a direct thrombin inhibitor or factor Xa inhibitor within the previous 48 hours with abnormal relevant coagulation tests; or use of heparin within the previous 24 hours with APTT above the upper limit of normal.
• History of ischemic stroke, severe head trauma, or myocardial infarction within the previous 3 months.
• History of intracranial hemorrhage.
• Intracranial or intraspinal surgery within the previous 3 months.
• Known intracranial tumor, cerebral arteriovenous malformation, giant intracranial aneurysm, or other intracranial lesion that may substantially increase the risk of intracranial hemorrhage.
• Baseline head CT showing acute or previous intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Qiang Wei

CONTACT

+86 18788832124; qiangwei_914@126.com

Wenchen Sun

CONTACT

vince1240@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to treatment assignment. Imaging assessments are centrally evaluated by an independent core laboratory blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): September 6, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

CN (1)