A Phase 3 interventional study of Recombinant Human Prourokinase for Injection (rhPro-UK) and Standard medical treatment (SMT) in Acute Ischemic Stroke, sponsored by The First Affiliated Hospital of Anhui Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by The First Affiliated Hospital of Anhui Medical University · Phase 3, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 616 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →The First Affiliated Hospital of Anhui Medical University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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 top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Participants assigned to this group will receive standard medical treatment alone.
Other: Standard medical treatment (SMT)
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 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.
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.
Time frame: 90 days after randomization (±7 days)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
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
Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score will be assessed.
Time frame: 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.
Time frame: 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.
Time frame: 90 days after randomization (±7 days)
Proportion of Participants With Symptomatic Intracranial Hemorrhage According to the SITS-MOST Criteria
Symptomatic intracranial hemorrhage is defined according to the SITS-MOST criteria as parenchymal hematoma type 2 (PH2) on brain imaging, accompanied by neurological deterioration of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS) from baseline or the lowest NIHSS score, or resulting in death.
Time frame: Within 36 hours after randomization
Proportion of Participants With Symptomatic Intracranial Hemorrhage According to the ECASS III Criteria
Symptomatic intracranial hemorrhage is defined according to the ECASS III criteria as any intracranial hemorrhage associated with neurological deterioration of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS), or death, with the hemorrhage identified as the predominant cause of the neurological deterioration or death.
Time frame: Within 36 hours after randomization
Proportion of Participants With Symptomatic Intracranial Hemorrhage According to the Heidelberg Bleeding Classification
Symptomatic intracranial hemorrhage is defined according to the Heidelberg Bleeding Classification as any intracranial hemorrhage associated with neurological deterioration, defined as an increase of at least 4 points in the total National Institutes of Health Stroke Scale (NIHSS) score or at least 2 points in a single NIHSS item, or neurological deterioration leading to a major medical or surgical intervention.
Time frame: Within 36 hours after randomization
Proportion of Participants With Any Intracranial Hemorrhage
Any intracranial hemorrhage is defined as any new intracranial hemorrhage detected on follow-up brain imaging, regardless of the presence of neurological deterioration, and classified according to the Heidelberg Bleeding Classification.
Time frame: Within 36 hours after randomization
Proportion of Participants With Moderate or Severe Systemic Bleeding According to the GUSTO Criteria
Systemic bleeding will be classified according to the GUSTO criteria. Moderate bleeding is defined as bleeding requiring blood transfusion, and severe or life-threatening bleeding is defined as bleeding causing substantial hemodynamic compromise requiring treatment. The outcome is the proportion of participants experiencing moderate or severe systemic bleeding.
Time frame: Within 90 days after randomization (±7 days)
Proportion of Participants Who Died From Any Cause
All-cause mortality is defined as death from any cause occurring during the follow-up period. The outcome will be reported as the proportion of participants who died from any cause.
Time frame: Through the 90-day follow-up visit (90 days after randomization ±7 days)
Proportion of Participants With Adverse Events
An adverse event (AE) is defined as any unfavorable medical occurrence after study treatment, including symptoms, signs, diseases, or abnormal laboratory findings, regardless of whether the event is considered related to the study treatment.
Time frame: From randomization through the 90-day follow-up visit (90 days ±7 days)
Proportion of Participants With Serious Adverse Events
A serious adverse event (SAE) is defined as an adverse medical event that results in death, is life-threatening, results in permanent or significant disability or loss of function, requires inpatient hospitalization or prolongation of existing hospitalization, or results in a congenital anomaly or birth defect.
Time frame: From randomization through the 90-day follow-up visit (90 days ±7 days)
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital of Anhui Medical University