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注册号: Registration number: |
ChiCTR2600123198 |
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最近更新日期: Date of Last Refreshed on: |
2026-04-22 16:14:27 |
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注册时间: Date of Registration: |
2026-04-22 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: |
昂戈瑞西单抗注射液治疗缺血性脑血管病的疗效研究 |
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Public title: |
Ongericimab Injection Reducing Recurrence of ischemic Stroke |
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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: |
昂戈瑞西单抗注射液治疗缺血性脑血管病的疗效研究 |
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Scientific title: |
Ongericimab Injection Reducing Recurrence of ischemic Stroke |
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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: |
戴丽叶 |
研究负责人: |
王拥军 |
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Applicant: |
Liye Dai |
Study leader: |
Yongjun Wang |
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申请注册联系人电话: Applicant telephone: |
+86 15010545290 |
研究负责人电话:
Study leader's |
+86 10 59978538 |
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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: |
yezidailiye@163.com |
研究负责人电子邮件: Study leader's E-mail: |
13811355059@139.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: |
北京市丰台区南四环西路119号 |
研究负责人通讯地址: |
北京市丰台区南四环西路119号 |
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Applicant address: |
119 South Fourth Ring West Road, Fengtai District, Beijing |
Study leader's address: |
119 South Fourth Ring West Road, Fengtai District, Beijing |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
首都医科大学附属北京天坛医院 |
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Applicant's institution: |
Beijing Tiantan Hospital, Capital Medical University |
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研究负责人所在单位: |
首都医科大学附属北京天坛医院 |
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Affiliation of the Leader: |
Beijing Tiantan Hospital, Capital 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: |
KY2025-365-02; KY2025-365-03; KY2025-365-04 |
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: |
首都医科大学附属北京天坛医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Beijing Tiantan Hospital Affiliated to Capital Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-11-18 00:00:00 | ||
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伦理委员会联系人: |
梁晓珊 |
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Contact Name of the ethic committee: |
Liang Xiaoshan |
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伦理委员会联系地址: |
北京市丰台区南四环西路119号 |
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Contact Address of the ethic committee: |
119 South Fourth Ring West Road, Fengtai District, Beijing |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 59975692 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
liangxiaoshan127@126.com |
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研究实施负责(组长)单位: |
首都医科大学附属北京天坛医院 |
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Primary sponsor: |
Beijing Tiantan Hospital, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市丰台区南四环西路119号 |
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Primary sponsor's address: |
119 South Fourth Ring West Road, Fengtai District, Beijing |
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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: |
重庆博创医药有限公司 |
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Source(s) of funding: |
Chongqing Bochuang Pharmaceutical Co., Ltd. |
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研究疾病: |
脑血管病 |
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Target disease: |
Cerebrovascular disease |
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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: |
评价在发病3个月内的动脉粥样硬化性缺血性脑血管患者中,使用昂戈瑞西单抗注射液以达到更低的降脂目标值(LDL-C<1.4mmol/L)能否降低其复发风险。 |
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Objectives of Study: |
To evaluate whether the use of Ongericimab injection in patients with atherosclerotic ischemic cerebrovascular disease within 3 months of onset can reduce the risk of recurrent major cardiovascular events by achieving lower lipid-lowering target values (LDL-C < 1.4 mmol/L). |
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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: |
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Inclusion criteria |
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排除标准: |
1.任何时期的脑出血病史(仅在SWI中存在微出血灶不是排除标准); 2.根据基线头CT或MRI诊断为出血或其他病理性神经系统疾病,例如血管畸形、肿瘤、脓肿或其他常见的非缺血性脑疾病(例如多发性硬化等); 3.仅存在单独的感觉症状(如麻木感),单独的视力改变,单独的头晕或眩晕,但基线头CT或MRI没有近期梗死证据; 4.随机化前无法完成颅内外动脉狭窄评估; 5.发病前mRS评分>2分(根据患者发病前病史评估); 6.血管成形术/血管外科手术导致的卒中; 7.心源性卒中(例如,由房颤、人工心脏瓣膜、心内膜炎、二尖瓣狭窄、窦房结功能障碍等所致); 8.随机分组前通过实验室检测的最近一次空腹甘油三酯>400 mg/dL(4.5 mmol/L); 9.控制效果不佳的高血压,定义为重复测量后收缩压(SBP) > 180 mmHg或舒张压(DBP) > 110 mmHg; 10.随机分组前3个月内曾使用任何PCSK9抑制剂; 11.随机化前1个月内诊断为甲状腺功能减退; 12.严重肾功能不全,定义为肾小球滤过率(eGFR) < 30 mL/min/1.73m^2; 13. 患有肝硬化、慢性活动性肝炎或严重肝脏疾病病史;或在筛查时出现不明原因的丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)>3倍正常值上限(ULN),或总胆红素>2倍ULN,且经过重复检测确认; 14. 随机化前1年内发生过NYHA III/IV型心力衰竭; 15. 合并严重的非心脑血管疾病,预期寿命1年以下; 16.10年内发生的恶性肿瘤(已充分治疗的基底细胞皮肤癌、宫颈原位癌、乳腺导管原位癌或1期前列腺癌除外); 17. 随机化前30天内参加过或正在接受药物或器械临床试验; 18. 拒绝采取有效避孕措施的育龄期女性,妊娠期或哺乳期妇女; 19. 已知对单克隆抗体治疗药物敏感; 20. 因精神疾患、认知或情绪障碍无法理解或服从该研究等研究者认为不合适参与本研究。 |
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Exclusion criteria: |
1.History of cerebral hemorrhage at any time (microhemorrhages present only on SWI are not an exclusion criterion); |
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研究实施时间: Study execute time: |
从 From 2026-04-22 00:00:00至 To 2029-07-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-04-22 00:00:00 至 To 2027-04-22 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): |
随机码列表将在合同研究组织(CRO)集中生成。 在治疗期间,患者将随机分配至低目标值组及高目标值组,分配到两组的随机概率为 1:1。 在第一天(基线随访)时随机顺序表将由计算机系统自动生成,受试者将按照随机分组接受相应的治疗方案。采取竞争入组原则,根据各中心的研究进展,可调配入选的病例数,但需要得到数据管理中心的确认。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The random code list will be centrally generated by the Contract Research Organization (CRO). During the treatment period, patients will be randomly assigned to either the low target value group or the high target value group, with an equal (1:1) randomization probability for both groups. On Day 1 (baseline visit), the randomization sequence will be automatically generated by the computer system, and subjects will receive the corresponding treatment regimen according to their assigned group. A competitive enrollment principle will be adopted, allowing for the allocation of enrolled cases based on the progress of each center, subject to confirmation by the Data Management Center. |
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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: |
不公开/Private |
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盲法: |
开放标签 |
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Blinding: |
Open-label |
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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: |
CRF, EDC |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
CRF, EDC |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |