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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2500109971 |
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最近更新日期: Date of Last Refreshed on: |
2025-09-28 11:10:12 |
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注册时间: Date of Registration: |
2025-09-28 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
急性缺血性极大核心梗死卒中患者血管内治疗的多中心、开放标签、盲法终点评估的随机对照研究 |
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Public title: |
Endovascular Treatment for Patients with Extreme Large Core Infarct Stroke: A Multi-center, Prospective, Open-label, Blind-endpoint Randomized Control Trial. |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
急性缺血性极大核心梗死卒中患者血管内治疗的多中心、开放标签、盲法终点评估的随机对照研究 |
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Scientific title: |
Endovascular Treatment for Patients with Extreme Large Core Infarct Stroke: A Multi-center, Prospective, Open-label, Blind-endpoint Randomized Control Trial. |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
资文杰 |
研究负责人: |
郑鹏 |
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Applicant: |
Zi Wenjie |
Study leader: |
Zheng Peng |
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申请注册联系人电话: Applicant telephone: |
+86 185 8101 0769 |
研究负责人电话:
Study leader's |
+86 185 8101 0769 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ziwenjie@126.com |
研究负责人电子邮件: Study leader's E-mail: |
282971157@qq.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
重庆市沙坪坝区新桥正街183号 |
研究负责人通讯地址: |
重庆市渝中区袁家岗友谊路1号 |
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Applicant address: |
183 Xinqiao Main Street, Shapingba, Chongqing, China |
Study leader's address: |
1st Youyi Road, Yuzhong District, Chongqing China |
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申请注册联系人邮政编码: Applicant postcode: |
400037 |
研究负责人邮政编码: Study leader's postcode: |
400016 |
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申请人所在单位: |
陆军军医大学第二附属医院(新桥医院) |
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Applicant's institution: |
Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University) |
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研究负责人所在单位: |
重庆医科大学附属第一医院 |
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Affiliation of the Leader: |
The First Affiliated Hospital of Chongqing Medical University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2025 年科研伦审(ZZ2025-381-01) |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
重庆医科大学附属第一医院伦理委员会 |
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Name of the ethic committee: |
Medical Research Ethics Review Committee of the First Affiliated Hospital of Chongqing Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-05-26 00:00:00 | ||
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伦理委员会联系人: |
严青 |
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Contact Name of the ethic committee: |
Yan Qing |
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伦理委员会联系地址: |
重庆市渝中区袁家岗友谊路1号 |
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Contact Address of the ethic committee: |
1st Youyi Road, Yuzhong District, Chongqing China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 23 8901 1876 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
444158752@qq.com |
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研究实施负责(组长)单位: |
重庆医科大学附属第一医院 |
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Primary sponsor: |
The First Affiliated Hospital of Chongqing Medical University |
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研究实施负责(组长)单位地址: |
重庆市袁家岗友谊路1号 |
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Primary sponsor's address: |
1st Youyi Road, Yu Zhong District, Chongqing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自选课题 |
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Source(s) of funding: |
Self funded |
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研究疾病: |
急性缺血性脑卒中 |
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Target disease: |
Acute Ischemic Stroke |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
III期临床试验 | ||||||||||||||||||||||
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Study phase: |
3 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
我们拟开展多中心、开放标签、盲法终点评估的随机对照研究,旨在探讨24h内极大核心梗死性卒中患者血管内治疗的有效性和安全性,为这部分临床尚缺乏有效疗法的患者提供高级别循证医学证据。 |
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Objectives of Study: |
We plan to conduct a multi-center, open-label, blinded endpoint randomized controlled trial aimed at evaluating the efficacy and safety of endovascular treatment in patients with large core infarction stroke within 24 hours, providing high-level evidence-based medical support for this patient group, which currently lacks effective clinical therapies. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1. 年龄 >= 18周岁; 2. 到院时间距离卒中发病或最后正常时间不超过24小时; 3. DSA/CTA/MRA检查证实前循环大、中血管闭塞; 4. CT/MRI下ASPECTS评分<=3; 5. 患者或家属签署书面知情同意书。 |
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Inclusion criteria |
1. Age >= 18 years; 2. Time from stroke onset or last known well to hospital arrival <= 24 hours; 3. DSA/CTA/MRA confirming occlusion of the anterior circulation large or medium vessels; 4. ASPECTS score <= 3 on CT/MRI; 5. Patient or legal guardian has signed the written informed consent. |
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排除标准: |
1. 经头颅计算机断层扫描(CT)或核磁共振成像(MRI)证实颅内出血; 2. 发病前mRS评分 >= 2分; 3. 妊娠或哺乳期妇女; 4. 遗传学或获得性出血体质,抗凝因子缺乏;或已使用抗凝药且INR>3; 5. 影像学上具有占位效应的颅内肿瘤(微小脑膜瘤除外); 6. 任何疾病晚期致预期寿命<6个月; 7. 预期不能完成随访; 8. 脑疝导致颅脑中线移位; 9. 含有严重并发症可能影响患者预后和随访(癌症、严重心衰、肾衰); 10. 怀疑脓毒性栓塞或细菌性心内膜炎; 11. 正参加其他临床试验。 |
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Exclusion criteria: |
1. Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 2. Pre-onset modified Rankin Scale (mRS) score >= 2; 3. Pregnant or breastfeeding women; 4. Genetic or acquired bleeding disorders, deficiency of anticoagulant factors; or current use of anticoagulants with an INR >3; 5. Intracranial tumors with mass effect on imaging (excluding small meningiomas); 6. End-stage disease with an expected survival of less than 6 months; 7. Expected inability to complete follow-up; 8. Brain herniation causing midline shift of the brain; 9. Presence of severe comorbidities potentially affecting prognosis and follow-up (e.g., cancer, severe heart failure, renal failure); 10. Suspected septic embolism or bacterial endocarditis; 11. Currently participating in other clinical trials. |
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研究实施时间: Study execute time: |
从 From 2025-02-01 00:00:00至 To 2028-02-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-10-01 00:00:00 至 To 2027-09-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
患者按照1:1 比例被随机分成两组。本试验采用分层隐匿区组长度的随机化的方法进行随机化分组,按照分中心进行分层,区组长度包括4、6 及8,患者以1:1 比例产生随机分组序列。各分中心研究者在患者签署知情同意书后报告组长单位研究者,后者通过随机化软件实现随机化分组。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Patients are randomly assigned to two groups at a 1:1 ratio. This trial uses a stratified concealed randomization method with variable block lengths for grouping, stratified by participating centers. Block lengths include 4, 6, and 8, and randomization sequences are generated with a 1:1 ratio. After patients sign the informed consent form, researchers at each participating center report to the researchers at the leading center, who then perform randomization via randomization software. |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
本试验对终点事件评估者及数据分析者设盲。本试验按照中心进行分层,由生物统计学家使用SAS9.4统计软件产生。 |
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Blinding: |
The trial will be blinded to endpoint event assessors and data analysts. It is stratified by center, with the randomization scheme generated by biostatisticians using SAS 9.4 statistical software. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
病例记录表 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |