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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
616
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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)
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