Acute Ischemic StrokePhase 3HOPE-MeVONCT07776873
Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke
A Phase 3 study testing Recombinant Human Prourokinase for Injection (rhPro-UK) and Standard medical treatment (SMT) in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Recombinant Human Prourokinase for Injection (rhPro-UK) and Standard medical treatment (SMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2026to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who have received reperfusion therapy, including intravenous thrombolysis, intra-arterial thrombolysis, or endovascular therapy (EVT), within 72 hours after the onset of the current stroke and before randomization..
- Patients with a clear treatment plan established before randomization that includes intravenous thrombolysis.
- Planned EVT or intra-arterial thrombolysis.
- 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.
Show all 27Show fewer
- 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.
- Baseline imaging showing a large cerebral infarction or marked early ischemic changes such that, in the investigator's judgment, intravenous thrombolytic treatment is inappropriate.
- Known severe adverse reaction to contrast media.
- Unable to undergo the required head CT, CTA, or CTP examinations, or imaging quality is insufficient to determine the responsible vessel occlusion and perfusion mismatch.
- Severe renal impairment with estimated glomerular filtration rate <30 mL/min or serum creatinine >2.5 mg/dL.
- Currently receiving hemodialysis or peritoneal dialysis.
- Suspected aortic dissection.
- Any advanced terminal illness with an anticipated life expectancy of no more than 6 months.
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test.
- Inability, in the investigator's judgment, to complete the 90-day follow-up, poor expected compliance, or otherwise unsuitable for participation in the study.
- Current participation in another interventional clinical study that may affect the efficacy or safety evaluation of this study, or participation in another interventional clinical study within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wenchen Sun contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Qiang Wei, +86 18788832124, qiangwei_914@126.com
Wenchen Sun, vince1240@163.com
About this study
Official title: Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke - A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial（HOPE-MeVO）
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
- Being tested
- Recombinant Human Prourokinase for Injection (rhPro-UK), Standard medical treatment (SMT)
- Keywords
- Medium Vessel Occlusion, Recombinant Human Prourokinase, Late-Window Intravenous Thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Prourokinase for Injection (rhPro-UK)Drug
Recombinant human prourokinase (rhPro-UK) is administered intravenously at a total dose of 35 mg: 15 mg over 3 minutes, followed by 20 mg over 30 minutes. Antithrombotic therapy is withheld for 24 hours after thrombolysis, with peri-thrombolysis monitoring performed according to standard intravenous thrombolysis practice. Other acute ischemic stroke treatment and subsequent management are individualized according to the 2026 AHA/ASA guideline and the participant's clinical condition.
Standard medical treatment (SMT)Other
Standard medical treatment consists of antiplatelet therapy selected by the investigator according to the participant's clinical condition. The regimen may consist of aspirin 100 mg/day plus clopidogrel 75 mg/day, aspirin 100 mg/day alone, or clopidogrel 75 mg/day alone. Other acute ischemic stroke treatment and subsequent management are individualized according to the 2026 AHA/ASA Guideline for the Early Management of Patients With Acute Ischemic Stroke and the participant's clinical condition.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Prourokinase Group | Experimental | Participants assigned to this group will receive intravenous recombinant human prourokinase (rhPro-UK) in addition to standard medical treatment. Receives: Drug: Recombinant Human Prourokinase for Injection (rhPro-UK) |
| Standard Medical Treatment Group | Active comparator | Participants assigned to this group will receive standard medical treatment alone. Receives: Other: Standard medical treatment (SMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after randomization (±7 days)
Secondary outcomes (10)
Distribution of Modified Rankin Scale Scores
The modified Rankin Scale (mRS) is an ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcome.
Measured: 90 days after randomization (±7 days)
Proportion of Participants With a Modified Rankin Scale Score of 0-2
Functional independence is defined as a modified Rankin Scale (mRS) score of 0-2. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating less disability.
Measured: 90 days after randomization (±7 days)
Proportion of Participants With Successful Recanalization of the Target Vessel
Successful recanalization is defined as an rAOL score of 2b or 3 on follow-up CT angiography (CTA) of the responsible medium vessel that was occluded at baseline.
Measured: 24 hours after randomization (-2/+12 hours)
Proportion of Participants With Imaging Reperfusion
Imaging reperfusion is defined as a greater than 90% reduction in the volume of the hypoperfused lesion with Tmax >6 seconds on CT perfusion imaging compared with baseline.
Measured: 24 hours after randomization (-2/+12 hours)
Infarct Volume Growth
Infarct volume growth is defined as the difference between the infarct core volume measured on follow-up imaging and the baseline infarct core volume measured by CT perfusion. The baseline infarct core is defined as tissue with relative cerebral blood flow (rCBF) <30%.
Measured: 24 hours after randomization (-2/+12 hours)
Proportion of Participants With Early Neurological Improvement
Early neurological improvement is defined as a National Institutes of Health Stroke Scale (NIHSS) score of 0-1 or an improvement of at least 4 points from baseline.
Measured: 24 hours after randomization (-2/+12 hours)
Change From Baseline in National Institutes of Health Stroke Scale Score at 24 Hours
Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score will be assessed.
Measured: Baseline to 24 hours after randomization (-2/+12 hours)
Change From Baseline in National Institutes of Health Stroke Scale Score at Day 7 or Discharge
Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score will be assessed.
Measured: Baseline to 7 days after randomization (±1 day) or discharge
Health-Related Quality of Life Assessed by the EQ-5D-5L
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five response levels for each dimension.
Measured: 90 days after randomization (±7 days)
Barthel Index Score
Activities of daily living will be assessed using the Barthel Index (BI). The total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
Measured: 90 days after randomization (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start6 Oct 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panpan Hu, MD, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776873
- Sponsor's protocol ID
- KY2026-08-72(1)
- Acronym
- HOPE-MeVO
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke - A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial（HOPE-MeVO）
- ClinicalTrials.gov ID
- NCT07776873
- Acronym / sponsor ID
- HOPE-MeVO / KY2026-08-72(1)
- Conditions
- Acute Ischemic Stroke
- Keywords
- Medium Vessel Occlusion, Recombinant Human Prourokinase, Late-Window Intravenous Thrombolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Prourokinase Group | Experimental | Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)Participants assigned to this group will receive intravenous recombinant human prourokinase (rhPro-UK) in addition to standard medical treatment. |
| Standard Medical Treatment Group | Active comparator | Other: Standard medical treatment (SMT)Participants assigned to this group will receive standard medical treatment alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (27 listed)
- Patients who have received reperfusion therapy, including intravenous thrombolysis, intra-arterial thrombolysis, or endovascular therapy (EVT), within 72 hours after the onset of the current stroke and before randomization..
- Patients with a clear treatment plan established before randomization that includes intravenous thrombolysis.
- Planned EVT or intra-arterial thrombolysis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Prourokinase for Injection (rhPro-UK)Recombinant human prourokinase (rhPro-UK) is administered intravenously at a total dose of 35 mg: 15 mg over 3 minutes, followed by 20 mg over 30 minutes. Antithrombotic therapy is withheld for 24 hours after thrombolysis, with peri-thrombolysis monitoring performed according to standard intravenous thrombolysis practice. Other acute ischemic stroke treatment and subsequent management are individualized according to the 2026 AHA/ASA guideline and the participant's clinical condition. | Drug | Recombinant Human Prourokinase Group |
| Standard medical treatment (SMT)Standard medical treatment consists of antiplatelet therapy selected by the investigator according to the participant's clinical condition. The regimen may consist of aspirin 100 mg/day plus clopidogrel 75 mg/day, aspirin 100 mg/day alone, or clopidogrel 75 mg/day alone. Other acute ischemic stroke treatment and subsequent management are individualized according to the 2026 AHA/ASA Guideline for the Early Management of Patients With Acute Ischemic Stroke and the participant's clinical condition. | Other | Standard Medical Treatment Group |
Primary outcome
Proportion of Participants With a Modified Rankin Scale Score of 0-1
Time frame: 90 days after randomization (±7 days)
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.
10 secondary outcomes
Distribution of Modified Rankin Scale Scores
Time frame: 90 days after randomization (±7 days)
Proportion of Participants With a Modified Rankin Scale Score of 0-2
Time frame: 90 days after randomization (±7 days)
Proportion of Participants With Successful Recanalization of the Target Vessel
Time frame: 24 hours after randomization (-2/+12 hours)
Proportion of Participants With Imaging Reperfusion
Time frame: 24 hours after randomization (-2/+12 hours)
Infarct Volume Growth
Time frame: 24 hours after randomization (-2/+12 hours)
Proportion of Participants With Early Neurological Improvement
Time frame: 24 hours after randomization (-2/+12 hours)
Change From Baseline in National Institutes of Health Stroke Scale Score at 24 Hours
Time frame: Baseline to 24 hours after randomization (-2/+12 hours)
Change From Baseline in National Institutes of Health Stroke Scale Score at Day 7 or Discharge
Time frame: Baseline to 7 days after randomization (±1 day) or discharge
Health-Related Quality of Life Assessed by the EQ-5D-5L
Time frame: 90 days after randomization (±7 days)
Barthel Index Score
Time frame: 90 days after randomization (±7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenchen Sun contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Prourokinase for Injection (rhPro-UK) and Standard medical treatment (SMT) in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Wei (+86 18788832124, qiangwei_914@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a Modified Rankin Scale Score of 0-1 (time frame: 90 days after randomization (±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.