NCT07776873尚未招募3 期
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 First Affiliated Hospital of Anhui Medical University1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2026年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- Proportion of Participants With a Modified Rankin Scale Score of 0-1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to treatment assignment. Imaging assessments are centrally evaluated by an independent core laboratory blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Pre-stroke modified Rankin Scale (mRS) score of 0-
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Recombinant Human Prourokinase Group
Experimental
Participants assigned to this group will receive intravenous recombinant human prourokinase (rhPro-UK) in addition to standard medical treatment.
干预措施: Recombinant Human Prourokinase for Injection (rhPro-UK) (Drug)
Recombinant Human Prourokinase Group
Experimental
Participants assigned to this group will receive intravenous recombinant human prourokinase (rhPro-UK) in addition to standard medical treatment.
干预措施: Standard medical treatment (SMT) (Other)
Standard Medical Treatment Group
Active Comparator
Participants assigned to this group will receive standard medical treatment alone.
干预措施: Standard medical treatment (SMT) (Other)
结局指标
主要结局
Proportion of Participants With a Modified Rankin Scale Score of 0-1
时间窗: 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.
次要结局
- 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))
- Proportion of Participants With Early Neurological Improvement(24 hours after randomization (-2/+12 hours))
- Change From Baseline in National Institutes of Health Stroke Scale Score at 24 Hours(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(Baseline to 7 days after randomization (±1 day) or discharge)
- Health-Related Quality of Life Assessed by the EQ-5D-5L(90 days after randomization (±7 days))
- Barthel Index Score(90 days after randomization (±7 days))
研究者
Panpan Hu, MD
Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Anhui Medical University
研究点 (1)
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