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.
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.
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.
Parallel
Recombinant Human Prourokinase for Injection (rhPro-UK)
DrugRecombinant 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 interventionStandard 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.
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.
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.
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.
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.
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.
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.
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.
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.
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