Ongericimab Injection Reducing Recurrence of Ischemic Stroke (ORIS)

April 15, 2026 updated by: Yongjun Wang, Beijing Tiantan Hospital

A Multicenter, Randomized, Open-label, Parallel-controlled, Event-driven, Blinded-endpoint Trial Evaluating the Efficacy and Safety of Ongericimab Injection in High-risk Stroke Patients With Intracranial or Extracranial Atherosclerotic Stenosis.

The Oris trial aims 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4810

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
        • Contact:
    • Anhui
      • Fuyang, Anhui, China, 236004
      • Wuhu, Anhui, China, 241001
        • The First Affiliated Hospital of Wannan Medical College
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102499
        • The First Hospital of Fangshan District, Beijing
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400023
        • Chongqing Sanbo Changan Hospital
        • Contact:
      • Chongqing, Chongqing Municipality, China, 400062
        • The Fifth People's Hospital of Chongqing
        • Contact:
      • Chongqing, Chongqing Municipality, China, 401334
        • The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College
        • Contact:
    • Fujian
      • Ningde, Fujian, China, 352100
        • Ningde People's Hospital
        • Contact:
    • Gansu
      • Dingxi, Gansu, China, 748400
        • Minxian County Hospital of Traditional Chinese Medicine
        • Contact:
      • Jiuquan, Gansu, China, 735008
        • Shanghai General Hospital Jiuquan Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730070
        • Gansu Provincial Maternity and Child-care Hospital(Gansu Provincial Central Hospital)
        • Contact:
      • Lanzhou, Gansu, China, 730100
        • The First People's Hospital of Yuzhong County
        • Contact:
      • Tianshui, Gansu, China, 741000
        • First People's Hospital of Tianshui
        • Contact:
    • Guangdong
      • Huizhou, Guangdong, China, 516003
        • Huizhou First Hospital
        • Contact:
      • Huizhou, Guangdong, China, 516300
        • Huidong People'S Hospital
        • Contact:
      • Shaoguan, Guangdong, China, 512100
        • Shaoguan Qujiang District People's Hospital
        • Contact:
      • Zhanjiang, Guangdong, China, 524557
        • Wuchuan People's Hospital
        • Contact:
    • Guangxi
      • Baise City, Guangxi, China, 533099
        • Baise City People's Hospital
        • Contact:
      • Liuchow, Guangxi, China, 545005
        • Liuzhou Worker's Hospital
        • Contact:
    • Guizhou
      • Anshun, Guizhou, China, 562100
        • Puding County People's Hospital
        • Contact:
      • Kaili, Guizhou, China, 556099
        • The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture
        • Contact:
      • Tongren, Guizhou, China, 554300
        • Tongren People's Hospital
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570311
        • The Second Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University
        • Contact:
      • Baoding, Hebei, China, 071051
        • The No.2 Hospital Of Baoding
        • Contact:
      • Baoding, Hebei, China, 071030
        • Hebei Tang County People's Hospital
        • Contact:
      • Handan, Hebei, China, 057150
        • HanDan Central Hospital
        • Contact:
      • Handan, Hebei, China, 056500
      • Handan, Hebei, China, 056800
        • Weixian People's Hospital
        • Contact:
      • Handan, Hebei, China, 057450
        • Qiuxian County People's Hospital
        • Contact:
      • Hejian, Hebei, China, 062450
        • Hejian People's Hospital
        • Contact:
      • Hengshui, Hebei, China, 053000
        • Hengshui People's Hospital
        • Contact:
      • Hengshui, Hebei, China, 053000
        • The NO.4 People's Hospital of Hengshui
        • Contact:
      • Qinhuangdao, Hebei, China, 066699
        • The second Hospital of Qinhuangdao
        • Contact:
      • Qinhuangdao, Hebei, China, 066002
        • Tianjin Cancer Hospital Qinhuangdao Branch
        • Contact:
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China, 050699
        • Xingtang County People's Hospital
        • Contact:
      • Shijiazhuang, Hebei, China, 052360
        • Xinji Traditional Chinese Medicine Hospital
        • Contact:
      • Tangshan, Hebei, China, 063199
        • Guye District Hospital of Traditional Chinese Medicine, Tangshan
        • Contact:
      • Tangshan, Hebei, China, 064199
        • Yutian County Hospital of Traditional Chinese Medicine
        • Contact:
      • Xingtai, Hebei, China, 054001
        • Xingtai People's Hospital
        • Contact:
      • Xingtai, Hebei, China, 054000
        • Xingtai central hospital
        • Contact:
      • Xingtai, Hebei, China, 054700
      • Xingtai, Hebei, China, 054899
      • Zhangjiakou, Hebei, China, 075199
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Daqing Oilfield General Hospital
        • Contact:
      • Daqing, Heilongjiang, China, 163000
        • Daqing No.4 hospital
        • Contact:
      • Daqing, Heilongjiang, China, 163453
      • Harbin, Heilongjiang, China, 150001
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 150086
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 164000
        • Beian No.1 People's Hospital
        • Contact:
      • Heihe, Heilongjiang, China, 164300
        • No.1 People'S Hospital of Heihe
        • Contact:
      • Jiamusi, Heilongjiang, China, 154000
        • The First Affiliated Hospital of Jiamusi University
        • Contact:
      • Jiamusi, Heilongjiang, China, 154000
        • The Hongda Hospital of Jiamusi University
        • Contact:
      • Jixi, Heilongjiang, China, 158300
        • Mudanjiang Hospital of Beidahuang Group
        • Contact:
      • Qiqihar, Heilongjiang, China, 161000
        • The Second Affiliated Hospital of Qiqihar Medical University
        • Contact:
      • Shuangyashan, Heilongjiang, China, 155811
        • Hongxinglong Hospital of Beidahuang Group
        • Contact:
    • Henan
      • Hebi, Henan, China, 458031
        • Hebi Coal Industry (Group) Co., Ltd. General Hospital
        • Contact:
      • Jiaozuo, Henan, China, 454350
        • Xiuwu County People's Hospital
        • Contact:
      • Jiaozuo, Henan, China, 454001
        • Jiaozuo Coal Mining Group Co., Ltd. Central Hospital
        • Contact:
      • Jiaozuo, Henan, China, 454001
        • The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)
        • Contact:
      • Jiaozuo, Henan, China, 454550
        • Qinyang City Hospital of Traditional Chinese Medicine
        • Contact:
          • Gongping Zhu
          • Phone Number: 13782701968
          • Email: zgp2@126.com
      • Jiaozuo, Henan, China, 454550
        • Qinyang People's Hospital
        • Contact:
      • Jiaozuo, Henan, China, 454750
        • Mengzhou Fuxing Hospital
        • Contact:
      • Jiaozuo, Henan, China, 454750
        • Mengzhou Hospital of Traditional Chinese Medicine
        • Contact:
      • Jiyuan, Henan, China, 459001
        • Jiyuan Hospital of Traditional Chinese Medicine
        • Contact:
      • Luoyang, Henan, China, 471009
        • Luoyang Central Hospital
        • Contact:
      • Luoyang, Henan, China, 471002
        • Luoyang First People's Hospital
        • Contact:
      • Luoyang, Henan, China, 471099
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanyang, Henan, China, 473400
        • People'S Hospital of Tanghe
        • Contact:
      • Pingdingshan, Henan, China, 467000
        • Pingdingshan The second people's hospital
        • Contact:
      • Pingdingshan, Henan, China, 467099
        • The First People's Hospital of Pingdingshan
        • Contact:
      • Puyang, Henan, China, 457000
        • Puyang People's Hospital
        • Contact:
      • Puyang, Henan, China, 457000
        • Puyang Oilfield General Hospital
        • Contact:
      • Puyang, Henan, China, 457000
        • Chinese Medicine Hospital Of Puyang
        • Contact:
      • Puyang, Henan, China, 457161
        • Puyang County People's Hospital
        • Contact:
      • Puyang, Henan, China, 457400
        • Nanle People's Hospital
        • Contact:
      • Sanmenxia, Henan, China, 472000
      • Sanmenxia, Henan, China, 472599
        • The First People Hospital of Lingbao
        • Contact:
      • Sanmenxia, Henan, China, 472000
        • Yellow River Sanmenxia Hospital
        • Contact:
      • Shangqiu, Henan, China, 476000
        • Shang Qiu Hospital of Tcm
        • Contact:
      • Shangqiu, Henan, China, 476700
        • People's hospital of NingLing
        • Contact:
      • Shangqiu, Henan, China, 476999
        • Sui county traditional Chinese medicine hospital
        • Contact:
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Henan Medical University
        • Contact:
      • Xinyang, Henan, China, 464399
      • Xuchang, Henan, China, 461500
        • Changge People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 452370
        • Xinmi Hospital of T.C.M
        • Contact:
      • Zhengzhou, Henan, China, 450199
        • Xingyang People's Hospital
        • Contact:
      • Zhoukou, Henan, China, 461300
        • Zhoukou Yongshan Hospital
        • Contact:
      • Zhoukou, Henan, China, 461499
        • Taikang Xian People's Hospital
        • Contact:
      • Zhumadian, Henan, China, 463000
        • Zhumadian Central Hospital
        • Contact:
      • Zhumadian, Henan, China, 463000
        • The First People's Hospital of Zhumadian
        • Contact:
      • Zhumadian, Henan, China, 463200
        • The People's Hospital of Queshan County
        • Contact:
      • Zhumadian, Henan, China, 463799
        • The People's Hospital Of Biyang County
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Xianning, Hubei, China, 437000
        • Xianning Central Hospital
        • Contact:
    • Hunan
      • Changde, Hunan, China, 415700
        • Taoyuan People'S Hospital
        • Contact:
      • Changsha, Hunan, China, 410399
        • Liuyang Jili Hospital
        • Contact:
      • Chenzhou, Hunan, China, 423099
        • Chenzhou No.1 people's Hospital
        • Contact:
      • Chenzhou, Hunan, China, 423000
        • Chenzhou 3rd People's Hospital
        • Contact:
      • Loudi, Hunan, China, 417100
        • Lianyuan People's Hospital
        • Contact:
      • Yongzhou, Hunan, China, 425199
        • The Affiliated Hospital of Yongzhou Vocational and Technical College
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Baotou City Central Hospital
        • Contact:
      • Baotou, Inner Mongolia, China, 221116
        • Sinopharm North Hospital
        • Contact:
      • Bayan Nur, Inner Mongolia, China, 015000
        • Bayannur Hospital
        • Contact:
      • Bayan Nur, Inner Mongolia, China, 015100
        • Wuyuan County People's Hospital
        • Contact:
      • Chifeng, Inner Mongolia, China, 024000
        • Affiliated Hospital of Chifeng University
        • Contact:
      • Chifeng, Inner Mongolia, China, 024005
        • Chifeng Hospital of Traditional Chinese and Mongolian Medicine
        • Contact:
      • Chifeng, Inner Mongolia, China, 024200
        • Chifeng City Center Hospital Ningcheng County
        • Contact:
      • Chifeng, Inner Mongolia, China, 024200
        • Ningcheng County Hospital of Traditional Chinese and Mongolian Medicine
        • Contact:
      • Hohhot, Inner Mongolia, China, 010200
        • Tuoketuo County Hospital
        • Contact:
      • Tongliao, Inner Mongolia, China, 028000
        • Tongliao People's Hospital
        • Contact:
      • Yakeshi, Inner Mongolia, China, 022150
        • Inner Mongolia Forestry General Hospital
        • Contact:
      • Zhalantun, Inner Mongolia, China, 162650
        • Zhalantun Hospital of Traditional Chinese and Mongolian Medicine
        • Contact:
      • Zhalantun, Inner Mongolia, China, 162650
        • Zhalantun People's Hospital
        • Contact:
    • Jiangsu
      • Huai'an, Jiangsu, China, 223400
        • Lianshui County People's Hospital
        • Contact:
      • Suqian, Jiangsu, China, 223798
    • Jiangxi
      • Jingdezhen, Jiangxi, China, 333099
        • The First People's Hospital of Jingdezhen
        • Contact:
      • Jiujiang, Jiangxi, China, 332000
        • Jiujiang No.1 People's Hospital
        • Contact:
      • Shangrao, Jiangxi, China, 335100
        • Yugan Xinjiang hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130033
        • China-Japan Union Hospital of Jilin University
        • Contact:
      • Meihekou, Jilin, China, 135000
        • Meihekou Central Hospital
        • Contact:
      • Siping, Jilin, China, 136099
        • Siping City Central People's Hospital
        • Contact:
      • Tonghua, Jilin, China, 134001
        • Tonghua Dongchang District People's Hospital
        • Contact:
    • Liaoning
      • Benxi, Liaoning, China, 117000
        • General Hospital of Benxi Iron
        • Contact:
      • Benxi, Liaoning, China, 117100
        • Benxi Central Hospital
        • Contact:
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Dalian, Liaoning, China, 116041
        • Dalian Lvshunkou District Traditional Chinese Medicine Hospital
        • Contact:
      • Dalian, Liaoning, China, 116000
        • Central Hospital of Dalian University of Technology （Dalian Municipal Central Hospital）
        • Contact:
      • Dalian, Liaoning, China, 116021
        • Dalian University Affiliated Xinhua Hospital
        • Contact:
      • Dalian, Liaoning, China, 116199
        • Dalian Jinzhou District First People's Hospital
        • Contact:
      • Dalian, Liaoning, China, 116300
        • Wafangdian Third Hospital Co., Ltd.
        • Contact:
      • Dandong, Liaoning, China, 118000
        • Dandong Central Hospital
        • Contact:
      • Dandong, Liaoning, China, 118000
        • Dandong First Hospital
        • Contact:
      • Fushun, Liaoning, China, 113008
        • Liaoning Health Industry Group Fukuang General Hospital
        • Contact:
      • Huludao, Liaoning, China, 125001
        • Huludao Central Hospital
        • Contact:
      • Shenyang, Liaoning, China, 110067
        • The People's Hospital of Liaoning Province
        • Contact:
      • Shenyang, Liaoning, China, 110041
        • The first people's hospital of Shenyang
        • Contact:
      • Shenyang, Liaoning, China, 110024
        • Central Hospital Affiliated to Shenyang Medical College
        • Contact:
      • Shenyang, Liaoning, China, 110016
        • Northern Theater Command General Hospital
        • Contact:
      • Shenyang, Liaoning, China, 110042
        • Northern Theater Command Air Force Hospital
        • Contact:
      • Tieling, Liaoning, China, 112400
        • The First Hospital of Xifeng County
        • Contact:
    • Ningxia
      • Shizuishan, Ningxia, China, 753000
        • The Fifth People's Hospital of Ningxia
        • Contact:
      • Shizuishan, Ningxia, China, 753400
        • The third hospital of shi zui shan
        • Contact:
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Qinghai Provincial Traffic Hospital
        • Contact:
    • Shaanxi
      • Shenmu, Shaanxi, China, 719300
        • Shenmu Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710016
        • Xi 'an Fengcheng Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710038
        • The Second Affiliated Hospital of Xi'an Medical University
        • Contact:
      • Yan’an, Shaanxi, China, 717399
        • Zichang People's Hospital
        • Contact:
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Binzhou Medical university hospital
        • Contact:
      • Binzhou, Shandong, China, 251800
        • Yangxin County People's Hospital
        • Contact:
      • Dezhou, Shandong, China, 253499
        • Ningjin People's Hospital
        • Contact:
      • Dezhou, Shandong, China, 251100
        • People's Hospital of Qihe County
        • Contact:
      • Dongying, Shandong, China, 257335
        • The Second People's Hospital of Dongying
        • Contact:
      • Heze, Shandong, China, 274799
        • Yuncheng County People's Hospital
        • Contact:
      • Jining, Shandong, China, 273100
      • Liaocheng, Shandong, China, 252037
      • Liaocheng, Shandong, China, 252899
        • The People's Hospital of Gaotang
        • Contact:
      • Liaocheng, Shandong, China, 252000
        • Liaocheng Brain Hospital
        • Contact:
      • Liaocheng, Shandong, China, 252001
        • Liaocheng City Central Hospital
        • Contact:
      • Liaocheng, Shandong, China, 252006
        • The Third People Hospital in Liaocheng
        • Contact:
      • Liaocheng, Shandong, China, 252699
        • The people's Hospital of Linqing
        • Contact:
      • Qingdao, Shandong, China, 266000
        • Qingdao Cardiovascular Hospital Co., Ltd.
        • Contact:
      • Tai’an, Shandong, China, 271099
        • The Second Affiliated Hospital of Shandong First Medical University
        • Contact:
      • Weifang, Shandong, China, 261000
      • Weifang, Shandong, China, 261500
      • Weifang, Shandong, China, 262400
        • People's Hospital of Changle County
        • Contact:
      • Weihai, Shandong, China, 264400
        • Weihai Central Hospital
        • Contact:
      • Weihai, Shandong, China, 264499
        • Weihai Wendeng District People's Hospital
        • Contact:
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
        • Contact:
      • Yantai, Shandong, China, 265699
        • Yantai Penglai traditional Chinese medicine hospital
        • Contact:
      • Yantai, Shandong, China, 265301
        • Yantai Taocun Central Hospital
        • Contact:
      • Yantai, Shandong, China, 265399
        • Qixia traditional Chinese medicine hospital
        • Contact:
      • Yantai, Shandong, China, 264000
        • Yantai Hospital of Traditional Chinese Medicine
        • Contact:
      • Yantai, Shandong, China, 264006
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200333
        • Liqun Hospital, Putuo District, Shanghai
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200434
        • Shanghai Fourth People's Hospital, Affiliated to Tongji University
        • Contact:
      • Shanghai, Shanghai Municipality, China, 201999
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Changzhi People's Hospital
        • Contact:
      • Linfen, Shanxi, China, 041000
      • Shuozhou, Shanxi, China, 036002
        • Grand Hospital of Shuozhou
        • Contact:
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, China, 030001
        • Second Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, China, 030024
        • Shanxi Cardiovascular Hospital
        • Contact:
      • Yangquan, Shanxi, China, 045000
        • The First People's Hospital of Yangquan
        • Contact:
    • Sichuan
      • Meishan, Sichuan, China, 062000
        • Meishan Cardio Cerebrovascular Disease Hospital
        • Contact:
      • Suining, Sichuan, China, 629099
        • Suining Center Hospital
        • Contact:
      • Yibin, Sichuan, China, 644200
        • Jiang'an County Hospital of Traditional Chinese Medicine
        • Contact:
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830002
        • Xinjiang Production&Construaction Corps Hospital
        • Contact:
    • Yunnan
      • Nujiang, Yunnan, China, 673299
        • The People's Hospital of Nujiang Lisu Autonomous Prefecture
        • Contact:
      • Pu'er, Yunnan, China, 665199
        • Ninger People's Hospital
        • Contact:
    • Zhejiang
      • Huzhou, Zhejiang, China, 313000
        • Huzhou Central Hospital
        • Contact:
      • Jiaxing, Zhejiang, China, 314399
        • Haiyan People's Hospital
        • Contact:
      • Lishui, Zhejiang, China, 323000
      • Shaoxing, Zhejiang, China, 312000
        • Shaoxing People's Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325100
        • Department of Yongjia People's Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325600
        • Affiliated Yueqing Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Obtaining informed consent；
  • Age ≥18 years；
  • Patients with ischemic stroke within 3 months( NIHSS<15 before randomization);
  • Presence of ≥50% stenosis in major intracranial or extracranial arteries, and related to the symptoms of the current episode or the location of infarction；
  • LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.

Exclusion Criteria:

  • History of cerebral hemorrhage at any time (microhemorrhages present only on SWI are not an exclusion criterion)
  • Hemorrhage or other pathological neurological conditions on baseline brain CT/MRI (e.g., vascular malformations, tumors, abscesses, or common non-ischemic brain diseases like multiple sclerosis);
  • Presence of isolated sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness or vertigo, but no evidence of recent infarction on baseline head CT or MRI;
  • Unable to complete the assessment of intracranial and extracranial arterial stenosis before randomization
  • mRS score≥2 before onset (based on assessment of medical history);
  • Stroke caused by angioplasty/vascular surgery;
  • Cardioembolic stroke caused by atrial fibrillation, artificial heart valves, endocarditis, mitral stenosis, sinus node dysfunction, etc.
  • Most recent fasting triglycerides >400 mg/dL (4.5 mmol/L) prior to randomization;
  • Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg);
  • Hypothyroidism diagnosed within 1 month before randomization.
  • Severe renal impairment (eGFR <30 mL/min/1.73m²);
  • Active liver disease or dysfunction (AST/ALT >3×ULN within 30 days pre-randomization);
  • NYHA Class III/IV heart failure within 1 year prior to randomization;
  • Life-limiting non-cardiovascular diseases (life expectancy <1 years);
  • Malignancy within 10 years (excluding adequately treated basal cell carcinoma, cervical CIS, DCIS, or stage 1 prostate cancer);
  • Known hypersensitivity to monoclonal antibody therapies;
  • PCSK9 inhibitor use within 3 months before randomization.
  • Participation in other drug/device trials within 30 days;
  • Women of childbearing potential without contraception, pregnancy, or lactation;
  • Inability to understand or comply with the study due to mental illness, cognitive, or emotional disorders, or other reasons deemed unsuitable for participation in the study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group (High target group)
Standardized lipid-lowering therapy according to the Chinese Stroke Association Guidelines for Clinical Management of Cerebrovascular Diseases to achieve an LDL-C target below 70 mg/dL (1.8 mmol/L).
Combination product: High target group
Standardized lipid-lowering therapy according to the Chinese Stroke Association Guidelines for Clinical Management of Cerebrovascular Diseases to achieve an LDL-C target below 70 mg/dL (1.8 mmol/L)
Experimental: Intervention group (Low target group)
Ongericimab subcutaneous injection once every two weeks (150mg) or every four weeks(300mg) combined with standardized lipid-lowering therapy to achieve an LDL-C target below 55 mg/dL (1.4 mmol/L)
Combination product: Low target group
Ongericimab subcutaneous injection once every two weeks (150mg) or every four weeks(300mg) combined with standardized lipid-lowering therapy to achieve an LDL-C target below 55 mg/dL (1.4 mmol/L)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The major cardiovascular events
Time Frame: A median of 2 years follow-up
The composite primary end point of major cardiovascular events includes ischemic stroke, myocardial infarction, death from cardiovascular causes.
A median of 2 years follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
New ischemic stroke
Time Frame: A median follow-up of 2 years
Ischemic stroke refers to acute focal cerebral or retinal infarction, excluding other non-ischemic causes, and meeting any of the following conditions: (1) clinical symptoms or imaging evidence of acute new focal neurological deficit lasting more than 24 hours; or (2) focal symptoms or signs lasting less than 24 hours, but with imaging evidence of new infarction; or (3) progression of pre-existing vascular ischemic stroke (i.e., NIHSS increase of ≥ 4 on the basis of the primary ischemic stroke, excluding hemorrhagic transformation after infarction or symptomatic intracranial hemorrhage) lasting more than 24 hours, with new ischemic changes on head MRI or CT.
A median follow-up of 2 years
Myocardial infarction
Time Frame: A median of 2 year follow-up
A median of 2 year follow-up
Vascular death
Time Frame: A median of 2 years follow-up
A median of 2 years follow-up
Poor functional prognosis (mRS score > 1) at 1 year
Time Frame: A median of 2 years follow-up
A median of 2 years follow-up
Severity of new stroke
Time Frame: A median of 2 years follow-up
A median of 2 years follow-up
Absolute and percent changes in LDL-C levels
Time Frame: A median of 2 years follow-up
A median of 2 years follow-up
Treatment-emergent serious adverse events (SAEs) and adverse events (AEs)
Time Frame: A median of 2 years follow-up
Treatment-emergent serious adverse events (SAEs) and adverse events (AEs) include cerebral hemorrhage, injection site infections, muscle-related adverse events, new-onset diabetes mellitus, and clinically significant laboratory abnormalities encompassing hepatic/renal function markers, creatine kinase (CK), fasting glucose, and glycated hemoglobin (HbA1c) during the double-blind treatment phase.
A median of 2 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yongjun Wang, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORIS-2025-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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