Not yet taking people in ChinaPhase 3

Ongericimab to Prevent Another Ischemic Stroke in People With Narrowed Brain Arteries

Tests ongericimab for preventing repeat strokes in people with clogged arteries.

Plain-language title generated from the registry record
Registry title: Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Key facts

Where: Anshun, Baise City, Baoding, Baotou, Bayan Nur, Beijing, Benxi, Binzhou, Changchun, Changde, Changsha, Changzhi, Chenzhou, Chifeng, Chongqing, Dalian, Dandong, Daqing, Dezhou, Dingxi, Dongying, Fushun, Fuyang, Haikou, Handan, Harbin, Hebi, Heihe, Hejian, Hengshui, Heze, Hohhot, Huai'an, Huizhou, Huludao, Huzhou, Jiamusi, Jiaozuo, Jiaxing, Jingdezhen, Jining, Jiujiang, Jiuquan, Jixi, Jiyuan, Kaili, Lanzhou, Liaocheng, Linfen, Lishui, Liuzhou, Loudi, Luoyang, Meihekou, Meishan, Nanyang, Ningde, Nujiang, Pingdingshan, Pu'er, Puyang, Qingdao, Qinhuangdao, Qiqihar, Sanmenxia, Shanghai, Shangqiu, Shangrao, Shaoguan, Shaoxing, Shenmu, Shenyang, Shijiazhuang, Shizuishan, Shuangyashan, Shuozhou, Siping, Suining, Suqian, Tai’an, Taiyuan, Tangshan, Tianshui, Tieling, Tonghua, Tongliao, Tongren, Ürümqi, Weifang, Weihai, Wenzhou, Wuhan, Wuhu, Xi'an, Xianning, Xingtai, Xining, Xinxiang, Xinyang, Xuchang, Yakeshi, Yan’an, Yangquan, Yantai, Yibin, Yongzhou, Zhalantun, Zhangjiakou, Zhanjiang, Zhengzhou, Zhoukou, and Zhumadian, ChinaSee the 197 sites
Phase: Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had an ischemic stroke within the last 3 months and have a narrowed major artery linked to it. LDL cholesterol must still be high.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Ischemic stroke within 3 months, NIHSS score under 15 before randomization. At least 50% narrowing (stenosis) in a major artery inside or outside the skull, related to the current stroke or the area of infarction.
Earlier treatment: Cannot have used a PCSK9 inhibitor within 3 months before randomization.
Biomarker or test result: LDL-C of 70 mg/dL (1.8 mmol/L) or higher at screening.

Main reasons for not taking part

Any past brain hemorrhage (bleeding in the brain)
Stroke caused by a heart clot, for example from atrial fibrillation or artificial heart valves
Severe kidney problems (eGFR under 30 mL/min/1.73m²)
Active liver disease or liver enzymes (AST/ALT) over 3 times the upper limit of normal
Pregnancy or breastfeeding, or women who could become pregnant and use no contraception

Read by machine on 12 November 2026.

Where in China

Puding County People's HospitalAnshun, ChinaContact: Yunfei ZhaoNo longer taking part
Baise City People's HospitalBaise City, ChinaContact: Shaofa LiNo longer taking part
Affiliated Hospital of Hebei UniversityBaoding, ChinaContact: Weiying DiNo longer taking part
Hebei Tang County People's HospitalBaoding, ChinaContact: Chunyu DiNo longer taking part
The No.2 Hospital Of BaodingBaoding, ChinaContact: Fengli ZhaoNo longer taking part
Baotou City Central HospitalBaotou, ChinaContact: Yu FanNo longer taking part
Sinopharm North HospitalBaotou, ChinaContact: Min WangNo longer taking part
Bayannur HospitalBayan Nur, ChinaContact: Wen GaoNo longer taking part
WuYuan County People's HospitalBayan Nur, ChinaContact: Yongming ChenNo longer taking part
Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaContact: Yongjun Wang, MDNo longer taking part
The First Hospital of Fangshan District, BeijingBeijing, ChinaContact: Jianhua LiNo longer taking part
Benxi Central HospitalBenxi, ChinaContact: Chengguang SongNo longer taking part
General Hospital of Benxi IronBenxi, ChinaContact: Hang ZhaoNo longer taking part
Binzhou Medical University HospitalBinzhou, ChinaContact: Wenbin MaNo longer taking part
Yangxin County People's HospitalBinzhou, ChinaContact: Jishuang KangNo longer taking part
China-Japan Union Hospital of JiLin UniversityChangchun, ChinaContact: Ying XingNo longer taking part
Taoyuan People'S HospitalChangde, ChinaContact: Jing LeiNo longer taking part
Liuyang Jili HospitalChangsha, ChinaContact: Yuzhang BeiNo longer taking part
Changzhi People's HospitalChangzhi, ChinaContact: Bingxia LiNo longer taking part
Chenzhou 3rd People's HospitalChenzhou, ChinaContact: Huixiang TangNo longer taking part
Chenzhou No.1 People's HospitalChenzhou, ChinaContact: Xiaoxi YaoNo longer taking part
Affiliated Hospital of Chifeng UniversityChifeng, ChinaContact: Weili ZhaoNo longer taking part
Chifeng City Center Hospital Ningcheng CountyChifeng, ChinaContact: Lijuan DouNo longer taking part
Chifeng Hospital of Traditional Chinese and Mongolian MedicineChifeng, ChinaContact: Guozhi LuNo longer taking part
Ningcheng County Hospital of Traditional Chinese and Mongolian MedicineChifeng, ChinaContact: Yanqing BaiNo longer taking part
Chongqing Sanbo Changan HospitalChongqing, ChinaContact: Mingli ChenNo longer taking part
The Fifth People's Hospital of ChongqingChongqing, ChinaContact: Ge JinNo longer taking part
The First Affiliated Hospital of Chongqing Medical and Pharmaceutical CollegeChongqing, ChinaContact: Hao XieNo longer taking part
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)Dalian, ChinaContact: Hongling ZhaoNo longer taking part
Dalian Jinzhou District First People's HospitalDalian, ChinaContact: Huijuan SunNo longer taking part
Dalian Lvshunkou District Traditional Chinese Medicine HospitalDalian, ChinaContact: Changhao JiangNo longer taking part
Dalian University Affiliated Xinhua HospitalDalian, ChinaContact: Yi WangNo longer taking part
The First Affiliated Hospital of Dalian Medical UniversityDalian, ChinaContact: Bingwei ZhangNo longer taking part
Wafangdian Third Hospital Co., Ltd.Dalian, ChinaContact: Xingguo JiangNo longer taking part
Dandong Central HospitalDandong, ChinaContact: Cheng BiNo longer taking part
Dandong First HospitalDandong, ChinaContact: Lishu WanNo longer taking part
DA QING LongNan HospitalDaqing, ChinaContact: Kai HuiNo longer taking part
Daqing No.4 hospitalDaqing, ChinaContact: Yanhui WangNo longer taking part
Daqing Oilfield General HospitalDaqing, ChinaContact: Xuhai GongNo longer taking part
Ningjin People's HospitalDezhou, ChinaContact: Chunjie YangNo longer taking part
People's Hospital of Qihe CountyDezhou, ChinaContact: Haitao LiNo longer taking part
Minxian County Hospital of Traditional Chinese MedicineDingxi, ChinaContact: Zhixiang LiuNo longer taking part
The Second People's Hospital of DongyingDongying, ChinaContact: Chunlei LiNo longer taking part
Liaoning Health Industry Group Fukuang General HospitalFushun, ChinaContact: Hong ZhangNo longer taking part
Fuyang People's HospitalFuyang, ChinaContact: Jinghong LuNo longer taking part
The Second Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaContact: Bin ChenNo longer taking part
Cixian People's HospitalHandan, ChinaContact: Jinhai YanNo longer taking part
Handan Central HospitalHandan, ChinaContact: Huiyong HuoNo longer taking part
Qiuxian County People's HospitalHandan, ChinaContact: Xin WangNo longer taking part
Weixian People's HospitalHandan, ChinaContact: Xuekong LiNo longer taking part
Beian No.1 People's HospitalHarbin, ChinaContact: Kailu SunNo longer taking part
The 2nd Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Peifang LiuNo longer taking part
The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Di ZhongNo longer taking part
Hebi Coal Industry (Group) Co., Ltd. General HospitalHebi, ChinaContact: Yanhua ZhangNo longer taking part
No.1 People'S Hospital of HeiheHeihe, ChinaContact: Xuefei LiuNo longer taking part
Hejian People's HospitalHejian, ChinaContact: Dongqi LiuNo longer taking part
Hengshui People's HospitalHengshui, ChinaContact: Xiaoli WangNo longer taking part
The NO.4 People's Hospital of HengshuiHengshui, ChinaContact: Jianling ZhangNo longer taking part
Yuncheng County People's HospitalHeze, ChinaContact: Guoqiang YangNo longer taking part
Tuoketuo County HospitalHohhot, ChinaContact: Youjun LiuNo longer taking part
Lianshui County People's HospitalHuai'an, ChinaContact: Yadong YuNo longer taking part
Huidong People's HospitalHuizhou, ChinaContact: Tingna ZhuNo longer taking part
Huizhou First HospitalHuizhou, ChinaContact: Chunsheng CaiNo longer taking part
Huludao Central HospitalHuludao, ChinaContact: Changming XuNo longer taking part
Huzhou Central HospitalHuzhou, ChinaContact: Bing ZhangNo longer taking part
The First Affiliated Hospital of Jiamusi UniversityJiamusi, ChinaContact: Yuling JinNo longer taking part
The Hongda Hospital of Jiamusi UniversityJiamusi, ChinaContact: Changsi AiNo longer taking part
Jiaozuo Coal Mining Group Co., Ltd. Central HospitalJiaozuo, ChinaContact: Dongyun ChenNo longer taking part
Mengzhou Fuxing hospitalJiaozuo, ChinaContact: Dali LiNo longer taking part
Mengzhou Hospital of Traditional Chinese MedicineJiaozuo, ChinaContact: Baoguo XueNo longer taking part
Qinyang City Hospital of Traditional Chinese MedicineJiaozuo, ChinaContact: Gongping ZhuNo longer taking part
Qinyang People's HospitalJiaozuo, ChinaContact: Jiafeng DongNo longer taking part
The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)Jiaozuo, ChinaContact: Zhenyu KongNo longer taking part
Xiuwu County People's HospitalJiaozuo, ChinaContact: Guangming KangNo longer taking part
Haiyan People's HospitalJiaxing, ChinaContact: Zhenhua XiNo longer taking part
The First People's Hospital of JingdezhenJingdezhen, ChinaContact: Minghua CaoNo longer taking part
Qufu People's HospitalJining, ChinaContact: Huijie SunNo longer taking part
Jiujiang No.1 People's HospitalJiujiang, ChinaContact: Hongbing NieNo longer taking part
Shanghai General Hospital Jiuquan HospitalJiuquan, ChinaContact: Baihai GuoNo longer taking part
Mudanjiang Hospital of Beidahuang GroupJixi, ChinaContact: Chuanbao YuNo longer taking part
Jiyuan Hospital of Traditional Chinese MedicineJiyuan, ChinaContact: Hongqin YangNo longer taking part
The People's Hospital of the Qiandongnan Miao and Dong Autonomous PrefectureKaili, ChinaContact: Xiaosong LiNo longer taking part
Gansu Provincial Maternity and Child-care Hospital(Gansu Provincial Central Hospital)Lanzhou, ChinaContact: Rong YinNo longer taking part
The First People's Hospital of Yuzhong CountyLanzhou, ChinaContact: Xiaopo ShenNo longer taking part
Liaocheng Brain HospitalLiaocheng, ChinaContact: Xinbo ZhuangNo longer taking part
Liaocheng City Central HospitalLiaocheng, ChinaContact: Xiting ZhangNo longer taking part
Liaocheng People's HospitalLiaocheng, ChinaContact: Dong GuoNo longer taking part
The People's Hospital of GaotangLiaocheng, ChinaContact: Chunlei ZhangNo longer taking part
The people's Hospital of LinqingLiaocheng, ChinaContact: Wei ZhangNo longer taking part
The Third People Hospital in LiaochengLiaocheng, ChinaContact: Bo FengNo longer taking part
Linfen Central HospitalLinfen, ChinaContact: Hongguo DaiNo longer taking part
Lishui Central HospitalLishui, ChinaContact: Xiao PengNo longer taking part
Liuzhou Worker's HospitalLiuzhou, ChinaContact: Liya PanNo longer taking part
Lianyuan People's HospitalLoudi, ChinaContact: Yiyong ZhangNo longer taking part
Luoyang Central HospitalLuoyang, ChinaContact: Zhihui DuanNo longer taking part
Luoyang First People's HospitalLuoyang, ChinaContact: Jinfeng ShiNo longer taking part
The Second Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaContact: Yaliang YuNo longer taking part
Meihekou Central HospitalMeihekou, ChinaContact: Rui WangNo longer taking part
Meishan Cardio Cerebrovascular Disease HospitalMeishan, ChinaContact: Junyan ZengNo longer taking part
People'S Hospital of TangheNanyang, ChinaContact: Minqiang QuNo longer taking part
Ningde People's HospitalNingde, ChinaContact: Guoping ZouNo longer taking part
The People's Hospital of Nujiang Lisu Autonomous PrefectureNujiang, ChinaContact: Liqin HeNo longer taking part
Pingdingshan The second people's hospitalPingdingshan, ChinaContact: Yankuo WangNo longer taking part
The First People's Hospital of PingdingshanPingdingshan, ChinaContact: Hongxu WangNo longer taking part
Ninger People's HospitalPu'er, ChinaContact: Junyong ZhaoNo longer taking part
Chinese Medicine Hospital of PuyangPuyang, ChinaContact: Ruili LiuNo longer taking part
Nanle People's HospitalPuyang, ChinaContact: Tingting ZhangNo longer taking part
Puyang County People's HospitalPuyang, ChinaContact: Sumin BaiNo longer taking part
Puyang Oilfield General HospitalPuyang, ChinaContact: Yutie ZhaoNo longer taking part
Puyang People's HospitalPuyang, ChinaContact: Jintao GuoNo longer taking part
Qingdao Cardiovascular Hospital Co., Ltd.Qingdao, ChinaContact: Shiyao YouNo longer taking part
The Second Hospital of QinhuangdaoQinhuangdao, ChinaContact: Guanglei LiNo longer taking part
Tianjin Cancer Hospital Qinhuangdao BranchQinhuangdao, ChinaContact: Hongmei ZhangNo longer taking part
The Second Affiliated Hospital of Qiqihar Medical UniversityQiqihar, ChinaContact: Hongjiao WangNo longer taking part
Sanmenxia Central HospitalSanmenxia, ChinaContact: Shufang YaoNo longer taking part
The First People Hospital of LingbaoSanmenxia, ChinaContact: Wei WuNo longer taking part
Yellow River Sanmenxia HospitalSanmenxia, ChinaContact: Meng XueNo longer taking part
Liqun Hospital, Putuo District, ShanghaiShanghai, ChinaContact: Zongyan DangNo longer taking part
Shanghai Fourth People's Hospital Affiliated to Tongji UniversityShanghai, ChinaContact: Yibin FangNo longer taking part
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Jianren LiuNo longer taking part
People's hospital of NingLingShangqiu, ChinaContact: Zhixiang SuiNo longer taking part
Shang Qiu Hospital of TcmShangqiu, ChinaContact: Zhenggao ChenNo longer taking part
Sui county traditional Chinese medicine hospitalShangqiu, ChinaContact: Ying LiNo longer taking part
Yugan Xinjiang hospitalShangrao, ChinaContact: Fangqi TianNo longer taking part
Shaoguan Qujiang District People's HospitalShaoguan, ChinaContact: Cai ZhangNo longer taking part
Shaoxing People's HospitalShaoxing, ChinaContact: Yanxing ZhangNo longer taking part
Shenmu HospitalShenmu, ChinaContact: Shengli SunNo longer taking part
Central Hospital Affiliated to Shenyang Medical CollegeShenyang, ChinaContact: Runhui LiNo longer taking part
Northern Theater Command Air Force HospitalShenyang, ChinaContact: Jing WangNo longer taking part
Northern Theater Command General HospitalShenyang, ChinaContact: Huisheng ChenNo longer taking part
The First People's Hospital of ShenyangShenyang, ChinaContact: Li LiNo longer taking part
The People's Hospital of Liaoning ProvinceShenyang, ChinaContact: Muhui LinNo longer taking part
The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Junli ZhenNo longer taking part
Xingtang County People's HospitalShijiazhuang, ChinaContact: Yanxin WangNo longer taking part
Xinji Traditional Chinese Medicine HospitalShijiazhuang, ChinaContact: Yunsi CaoNo longer taking part
The Fifth People's Hospital of NingxiaShizuishan, ChinaContact: Jiqin YangNo longer taking part
The third hospital of shi zui shanShizuishan, ChinaContact: Juyan ZhangNo longer taking part
Hongxinglong Hospital of Beidahuang GroupShuangyashan, ChinaContact: Degang SunNo longer taking part
Grand Hospital of ShuozhouShuozhou, ChinaContact: Guan WeiNo longer taking part
Siping City Central People's HospitalSiping, ChinaContact: Junfeng ZhaoNo longer taking part
Suining Center HospitalSuining, ChinaContact: Wenli XingNo longer taking part
Siyang Kangda HospitalSuqian, ChinaContact: Yanan ZhuNo longer taking part
The Second Affiliated Hospital of Shandong First Medical UniversityTai’an, ChinaContact: Haitao WangNo longer taking part
First Hospital of Shanxi Medical UniversityTaiyuan, ChinaContact: Junhong GuoNo longer taking part
Second hospital of Shanxi Medical UniversityTaiyuan, ChinaContact: Zhanjin DengNo longer taking part
Shanxi Cardiovascular HospitalTaiyuan, ChinaContact: Chen ChenNo longer taking part
Guye District Hospital of Traditional Chinese Medicine, TangshanTangshan, ChinaContact: Xiangjun JiNo longer taking part
Yutian County Hospital of Traditional Chinese MedicineTangshan, ChinaContact: Zhiwei SongNo longer taking part
First People's Hospital of TianshuiTianshui, ChinaContact: Guoping MaNo longer taking part
The First Hospital of Xifeng CountyTieling, ChinaContact: Rui ZhangNo longer taking part
Tonghua Dongchang District People's HospitalTonghua, ChinaContact: Zhiquan ZhuNo longer taking part
Tongliao People's HospitalTongliao, ChinaContact: Shuyao WangNo longer taking part
Tongren People's HospitalTongren, ChinaContact: Long LiaoNo longer taking part
Xinjiang Production&Construaction Corps HospitalÜrümqi, ChinaContact: Yan LiuNo longer taking part
People's Hospital of Changle CountyWeifang, ChinaContact: Feng FenNo longer taking part
People's Hospital of GaomiWeifang, ChinaContact: Quanhao LiNo longer taking part
Weifang People's HospitalWeifang, ChinaContact: Li ZhouNo longer taking part
Weihai Central HospitalWeihai, ChinaContact: Xia ZhanNo longer taking part
Weihai Wendeng District People's HospitalWeihai, ChinaContact: Jinguo ZhaoNo longer taking part
Affiliated Yueqing Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Saizhen WuNo longer taking part
Department of Yongjia People's HospitalWenzhou, ChinaContact: Han YuNo longer taking part
Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Bin MeiNo longer taking part
The First Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaContact: Zhiming ZhouNo longer taking part
The Second Affiliated Hospital of Xi'an Medical UniversityXi'an, ChinaContact: Qi ZhouNo longer taking part
Xi 'an Fengcheng HospitalXi'an, ChinaContact: Aimei WuNo longer taking part
Xianning Central HospitalXianning, ChinaContact: Jie DuNo longer taking part
Qinghe people's hospitalXingtai, ChinaContact: Yingzhuo ZangNo longer taking part
Weixian People's HospitalXingtai, ChinaContact: Zhenlin WangNo longer taking part
Xingtai central hospitalXingtai, ChinaContact: Yongmei KongNo longer taking part
Xingtai People's HospitalXingtai, ChinaContact: Xipeng LiNo longer taking part
Qinghai Provincial Traffic HospitalXining, ChinaContact: Jinlei ZhuNo longer taking part
The First Affiliated Hospital of Henan Medical UniversityXinxiang, ChinaContact: Jianhua ZhaoNo longer taking part
People's Hospital of XixianXinyang, ChinaContact: Ruiyi WangNo longer taking part
Changge People's HospitalXuchang, ChinaContact: Gexia LiuNo longer taking part
Inner Mongolia Forestry General HospitalYakeshi, ChinaContact: Jing WangNo longer taking part
Zichang People's HospitalYan’an, ChinaContact: Runting JingNo longer taking part
The First People's Hospital of YangquanYangquan, ChinaContact: Jiabin ZhaoNo longer taking part
Qixia Traditional Chinese Medicine HospitalYantai, ChinaContact: Xiaoyan LiNo longer taking part
Yantai Hospital of Traditional Chinese MedicineYantai, ChinaContact: Lin SunNo longer taking part
Yantai Penglai traditional Chinese medicine hospitalYantai, ChinaContact: Penglai ShiNo longer taking part
Yantai Taocun Central HospitalYantai, ChinaContact: Zhihua HaoNo longer taking part
Yantai Yuhuangding HospitalYantai, ChinaContact: Zhigang LiangNo longer taking part
YEDA hospitalYantai, ChinaContact: Haihui LuanNo longer taking part
Jiang'an County Hospital of Traditional Chinese MedicineYibin, ChinaContact: Xiang LiuNo longer taking part
The Affiliated Hospital of Yongzhou Vocational and Technical CollegeYongzhou, ChinaContact: Jie YanNo longer taking part
Zhalantun Hospital of Traditional Chinese and Mongolian MedicineZhalantun, ChinaContact: Chengyan YangNo longer taking part
Zhalantun People's HospitalZhalantun, ChinaContact: Xiaoyu QuNo longer taking part
Xuangang HospitalZhangjiakou, ChinaContact: Lina QiaoNo longer taking part
Wuchuan People's HospitalZhanjiang, ChinaContact: Guanrong ChenNo longer taking part
Xingyang People's HospitalZhengzhou, ChinaContact: Dongliang YangNo longer taking part
Xinmi Hospital of T.C.MZhengzhou, ChinaContact: Jianmin GuoNo longer taking part
Taikang Xian People's HospitalZhoukou, ChinaContact: Xinxia ZhaoNo longer taking part
Zhoukou Yongshan HospitalZhoukou, ChinaContact: Jinqi FanNo longer taking part
The First People's Hospital of ZhumadianZhumadian, ChinaContact: Xumei LiNo longer taking part
The People's Hospital Of Biyang CountyZhumadian, ChinaContact: Shuo ZhangNo longer taking part
The People's Hospital of Queshan CountyZhumadian, ChinaContact: Jianxin XuNo longer taking part
Zhumadian Central HospitalZhumadian, ChinaContact: Wanchun LiNo longer taking part

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: Beijing Tiantan Hospital
Trial code: NCT07242599
Record updated: 16 April 2026
Original description: 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).Read full original descriptionShow less
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).
Inclusion: 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: Hypothyroidism diagnosed within 1 month before randomization; NYHA Class III/IV heart failure within 1 year prior to randomization; PCSK9 inhibitor use within 3 months before randomization; Participation in other drug/device trials within 30 days; 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); Stroke caused by angioplasty/vascular surgery; Cardioembolic stroke caused by atrial fibrillation, artificial heart valves, endocarditis, mitral stenosis, sinus node dysfunction, etc; Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg); Malignancy within 10 years (excluding adequately treated basal cell carcinoma, cervical CIS, DCIS, or stage 1 prostate cancer); Known hypersensitivity to monoclonal antibody therapies; 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; Most recent fasting triglycerides >400 mg/dL (4.5 mmol/L) prior to randomization; Severe renal impairment (eGFR <30 mL/min/1.73m²); Active liver disease or dysfunction (AST/ALT >3×ULN within 30 days pre-randomization); Life-limiting non-cardiovascular diseases (life expectancy <1 years); 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); Women of childbearing potential without contraception, pregnancy, or lactation.
ClinicalTrials.gov NCT07242599