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NCT06295679Active, not recruiting

A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease

A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination With Standard of Care Compared With Standard of Care Alone on Major Cardiovascular Events in Chinese Patients With Established Atherosclerotic Cardiovascular Disease

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
7000 (actual)
First submitted
26 Feb 2024
Start date
19 Dec 2022
Primary completion date
19 Dec 2028
Lead sponsor
Amgen
NCT number
NCT06295679

What you commit to

  • Study type: Observational
  • Participants enrolled: 7000
  • From 19 Dec 2022 to the primary completion date, 19 Dec 2028
  • 89 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior use of Repatha® or other proprotein convertase subtilisin/kexin type 9 inhibition treatments within past 6 months prior to enrollment.
  • Participants currently enrolled in another study involving any investigational procedure, device or drug.

Other illness

  • Stroke within past 1 month.
  • Known hemorrhagic stroke at any time.
  • Stroke due to thromboembolic event.
  • Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary.

Who the study is looking for

  • Adult participants ≥ 18 years of age.
  • Participants or participant's legally authorized representative has provided informed consent to participate in this study.
  • Participants who meet one of the following:
  • Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label.
    • OR
  • Already received SOC treatment prior to enrollment.
  • Participants with ANY of the following.
  • Diagnosis of MI OR stroke within 2 years before enrollment.
  • 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment.
  • Diagnosis of (MI OR stroke) AND diabetes.
  • Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as \> 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography).
  • Diagnosis of symptomatic peripheral arterial disease.
  • Most recent fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (≥ 2.6 mmol/L) within 6 months prior to enrollment.
  • Most recent fasting triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) within 6 months prior to enrollment.

Age in the registry: 18 years to 150 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fuwai Hospital Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing Anzhen Hospital, Capital Medical University
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BeijingChinaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Beijing Haidian Hospital
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Cangzhou Central Hospital
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CangzhouChinaUnknown status
The Second Norman Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Hunan Provincial Peoples Hospital
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ChangshaChinaUnknown status
Changshu No2 Peoples Hospital
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ChangshuChinaUnknown status
Changshu No1 Peoples Hospital
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ChangshuChinaUnknown status
Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
Chengdu Third Peoples Hospital
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ChengduChinaUnknown status
Chengdu First Peoples Hospital
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ChengduChinaUnknown status
Chongqing Emergency Medical Center
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ChongqingChinaUnknown status
Chongqing General Hospital
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ChongqingChinaUnknown status
The First Affiliated Hospital of Dalian Medical University
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DalianChinaUnknown status
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
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DalianChinaUnknown status
The Second Hospital of Dalian Medical University
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DalianChinaUnknown status
Dongguan Songshan Lake Central Hospital
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DongguanChinaUnknown status
The First Peoples Hospital of Foshan
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FoshanChinaUnknown status
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The Third Affiliated Hospital of Sun Yat-Sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Jinan University
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GuangzhouChinaUnknown status
The Sixth Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Nanfang Hospital, Southern Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Shantou University Medical College
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Guilin Medical University
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GuilinChinaUnknown status
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Heilongjiang Provincial Hospital
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HaerbinChinaUnknown status
the First Peoples Hospital of Xiaoshan District Hangzhou
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Fourth Hospital of Harbin Medical University
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HarbinChinaUnknown status
The Third Peoples Hospital of Huizhou
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HuizhouChinaUnknown status
The First Peoples Hospital of Huzhou
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HuzhouChinaUnknown status
Huzhou Central Hospital
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HuzhouChinaUnknown status
Jiaxing Second Hospital
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JiaxingChinaUnknown status
The First Affiliated Hospital of Shandong First Medical University
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JinanChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
Provincial Hospital Affiliated to Shandong First Medical University
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JinanChinaUnknown status
Affiliated Hospital of Jining Medical University
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JiningChinaUnknown status
The First Affiliated Hospital of Jinzhou Medical University
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JinzhouChinaUnknown status
Huaihe Hospital of Henan University
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KaifengChinaUnknown status
Yanan Hospital of Kunming City
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KunmingChinaUnknown status
The First Peoples Hospital of Yunnan Province
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KunmingChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Jiangxi Provincial Peoples Hospital
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NanchangChinaUnknown status
The First Hospital of Nanchang
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NanchangChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Nantong First Peoples Hospital
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NantongChinaUnknown status
Nanyang Central Hospital
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NanyangChinaUnknown status
Ningbo Medical Center Lihuili Hospital
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NingboChinaUnknown status
The First Affiliated Hospital of Ningbo University
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NingboChinaUnknown status
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Tongji Hospital of Tongji University
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ShanghaiChinaUnknown status
Shaoxing Second Hospital
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ShaoxingChinaUnknown status
General Hospital of Northern Theater Command
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ShenyangChinaUnknown status
The Fourth Affiliated Hospital of China Medical University
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ShenyangChinaUnknown status
The First Peoples Hospital of Kunshan
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SuzhouChinaUnknown status
First Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
The Second Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Tangshan Gongren Hospital
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TangshanChinaUnknown status
Tianjin Peoples Hospital
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TianjinChinaUnknown status
Tianjin Huanhu Hospital
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TianjinChinaUnknown status
Tianjin First Central Hospital
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TianjinChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tianjin Chest Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
The Central Hospital of Wuhan
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WuhanChinaUnknown status
Wuhan NO.1 Hospital
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WuhanChinaUnknown status
Wuhan Third Hospital-Tongren Hospital of Wuhan University
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WuhanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Wuxi Peoples Hospital
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WuxiChinaUnknown status
Shaanxi Provincial Peoples Hospital
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Xi'anChinaUnknown status
Tangdu Hospital of Air Force Medical University
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
The First Peoples Hospital of Yulin
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YulinChinaUnknown status
The Seventh Peoples Hospital of Zhengzhou
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ZhengzhouChinaUnknown status
Fuwai Central China Cardiovascular Hospital
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ZhengzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Zhuhai Peoples Hospital
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ZhuhaiChinaUnknown status
Zibo Central hospital
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ZiboChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.