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Pro-urokinase for Extended-Window Posterior Circulation Stroke (PROMISE)

2026年5月26日 更新者：Bo Song、The First Affiliated Hospital of Zhengzhou University

Pro-urokinase for Reperfusion in Acute pOsterior Circulation ischeMIc Stroke in the Extended Window (the PROMISE Trail): A Randomized, Double-blind, Baseline Treatment-controlled Study

This study aims to evaluate whether, in patients with imaging-confirmed acute ischemic stroke of the posterior circulation presenting within 4.5-24 hours after symptom onset and not scheduled for endovascular thrombectomy, intravenous thrombolysis with recombinant human prourokinase (rhPro-UK), compared with standard medical treatment, can achieve superior 90-day functional outcomes with a higher level of safety.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Stroke is the second leading cause of death and the third leading cause of disability worldwide. Posterior circulation ischemic stroke (PCIS) accounts for approximately 20% of all ischemic strokes. Due to involvement of critical structures such as the brainstem and cerebellum, PCIS is associated with rapid neurological deterioration, high disability and mortality rates, and often presents with atypical clinical manifestations, leading to frequent misdiagnosis and delayed treatment. Consequently, many patients miss the conventional 4.5-hour intravenous thrombolysis window. However, the posterior circulation possesses relatively abundant collateral circulation and stronger ischemic tolerance, resulting in a lower risk of intracranial hemorrhage after thrombolysis and suggesting the potential feasibility of an extended therapeutic window.

In recent years, multiple studies have promoted a paradigm shift in acute ischemic stroke management from a "time window"-based strategy to a "tissue window"-based strategy. Trials including EXTEND, TRACE-III, HOPE, and OPTION demonstrated that intravenous thrombolysis administered within 4.5-24 hours after symptom onset, guided by perfusion imaging selection, could still improve functional outcomes. The EXPECTS study further showed that patients with posterior circulation stroke who were not candidates for endovascular thrombectomy could benefit from alteplase treatment within 4.5-24 hours, with a relatively low risk of symptomatic intracranial hemorrhage. Nevertheless, limitations such as a high proportion of mild stroke cases, non-randomized study design, and baseline imbalance indicate that stronger evidence is still required.

Recombinant human prourokinase (rhPro-UK), a novel fibrin-specific thrombolytic agent independently developed in China, has advantages over rt-PA, including lower systemic fibrinolytic activation and reduced bleeding risk, making it potentially more suitable for extended-window thrombolysis. The PROST-2 trial demonstrated that rhPro-UK was non-inferior to rt-PA in efficacy among patients treated within 4.5 hours after acute ischemic stroke onset, while significantly reducing symptomatic intracranial hemorrhage and systemic bleeding events, highlighting its favorable safety profile and potential for extended-window application.

Therefore, this study aims to evaluate whether intravenous thrombolysis with rhPro-UK, compared with standard medical therapy, can achieve better 90-day functional outcomes and improved safety in patients with imaging-confirmed posterior circulation acute ischemic stroke presenting within 4.5-24 hours after symptom onset and not scheduled for endovascular thrombectomy.

研究类型

介入性

注册 (估计的)

586

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Henan
      • Zhengzhou、Henan、中国
        • Department of Neurology, the First Affiliated Hospital of Zhengzhou University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);

  3. Imaging criteria:

    1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
    2. DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
  4. NIHSS score 4-25;
  5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);
  6. Signed informed consent from the patient or legally authorized representative.

Exclusion Criteria:

  1. Planned endovascular treatment;
  2. Contradictory to MRI examination;
  3. MRI image not qualified for evaluation;
  4. Serious neurological deficits before onset (mRS≥2);
  5. Obvious head injuries or strokes within 3 months;
  6. Subarachnoid or intracranial hemorrhage;
  7. History of intracranial hemorrhage;
  8. Intracranial tumor, arteriovenous malformation or aneurysm;
  9. Intracranial or spinal cord surgery within 3 months;
  10. Active internal hemorrhage;
  11. platelet count of <100000/mm3;
  12. Aortic arch dissection;
  13. Heparin therapy within 24 hours;
  14. Oral warfarin is being taken and INR>1.6 or APTT abnormal;
  15. Oral anticoagulation therapy;
  16. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;
  17. Blood glucose < 50 mg/dl (2.7mmol/L);
  18. Pregnancy;
  19. Neurological deficit after epileptic seizures;
  20. Major surgery within 1 month;
  21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
  22. Myocardial infarction within 3 months;
  23. Allergy to study drugs;
  24. Unlikely to adhere to the trial protocol or follow-up;
  25. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
  26. Participation in other interventional clinical trials within the previous 3 months.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：rhPro-UK group
On Day 1 after randomization, patients will receive intravenous rhPro-UK plus aspirin placebo (300 mg). From day 2 to day 90, patients will receive standard care according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023).
药品：rhPro-UK
rhPro-UK (5 mg/vial), to maximum of 35mg
药品：placebo
Asprin (placebo)
有源比较器：Control group
On Day 1 after randomization, patients will receive rhPro-UK placebo plus oral aspirin (300 mg). From day 2 to day 90, patients will receive standard care according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023).
药品：阿司匹林
阿司匹林（300毫克）
药品：Placebo
rhPro-UK(placebo)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Modified Rankin Scale (mRS)
大体时间：90 ± 7 days]
Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.
90 ± 7 days]

次要结果测量

结果测量
措施说明
大体时间
改良Rankin量表（mRS）
大体时间：90 ± 7 天
定义为第90±7天mRS评分（0-2分）获得良好结局的受试者比例。
90 ± 7 天
改良Rankin量表（mRS）
大体时间：90 ± 7 天
90天mRS的序数转移分析
90 ± 7 天
国立卫生研究院卒中量表（NIHSS）
大体时间：24小时和7天
NIHSS 在 24 小时和 7 天时相对于基线的变化。
24小时和7天
巴塞尔指数（BI）
大体时间：90 ± 7 天
第90 ± 7天的Barthel指数评分。
90 ± 7 天
欧洲五维健康量表（EQ-5D）
大体时间：90 ± 7 天
通过EQ-5D量表在90±7天测量的生活质量。
90 ± 7 天
改良Rankin量表（mRS）
大体时间：90 ± 7 天
  1. 90±7天时mRS（0-2分）定义为优秀结局的受试者比例。
  2. 90±7天时mRS的序数分布
90 ± 7 天

其他结果措施

结果测量
措施说明
大体时间
死亡
大体时间：90天
90 天时的总体死亡率。
90天
症状性颅内出血（sICH）
大体时间：36小时
36小时内发生症状性颅内出血（sICH）的受试者比例（根据ECASS III标准）。
36小时
全身性出血
大体时间：90天
90天时系统性出血（根据GUSTO标准）
90天
不良事件（AEs）/严重不良事件（SAEs）
大体时间：90天
90天内出现不良事件（AEs）/严重不良事件（SAEs）的患者比例。
90天

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The First Affiliated Hospital of Zhengzhou University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年6月1日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PROMISE-001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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