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

Last updated: July 23, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT06295679
20180442
  • Ages 18-150
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants ≥ 18 years of age.

  • Participants or participant's legally authorized representative has providedinformed consent to participate in this study.

  • Participants who meet one of the following:

  • Prescribed Repatha® in addition to an existing SOC treatment according to localguidelines 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 arterycontrast enhanced computed tomography).

  • Diagnosis of symptomatic peripheral arterial disease.

  • Most recent fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or nonhigh-density lipoproteincholesterol (non-HDL-C) ≥ 100 mg/dL (≥ 2.6 mmol/L) within 6 months prior toenrollment.

  • Most recent fasting triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) within 6 months priorto enrollment.

Exclusion

Exclusion Criteria:

  • Stroke within past 1 month.

  • Known hemorrhagic stroke at any time.

  • Stroke due to thromboembolic event.

  • Any prior use of Repatha® or other proprotein convertase subtilisin/kexin type 9inhibition treatments within past 6 months prior to enrollment.

  • Participants currently enrolled in another study involving any investigationalprocedure, device or drug.

  • Participants prescribed Repatha® with a history of severe hypersensitivity orallergy to any subsidiary.

Study Design

Total Participants: 7000
Study Start date:
December 19, 2022
Estimated Completion Date:
December 19, 2028

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Beijing Haidian Hospital

    Beijing, Beijing 100086
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • China Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100037
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing 400014
    China

    Active - Recruiting

  • Chongqing General Hospital

    Chongqing, Chongqing 401121
    China

    Active - Recruiting

  • Dongguan Songshan Lake Central Hospital

    Dong Guan, Guangdong 523127
    China

    Active - Recruiting

  • The First Peoples Hospital of Foshan

    Foshan, Guangdong 528000
    China

    Active - Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • The First Affiliated Hospital Sun-Yat Sen University

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shantou University Medical College

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital Sun Yat-sen University

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • The Third Peoples Hospital of Huizhou

    Huizhou, Guangdong 516002
    China

    Active - Recruiting

  • The Third Peoples Hospital of Huizhou City

    Huizhou, Guangdong 516002
    China

    Active - Recruiting

  • Zhuhai Peoples Hospital

    Zhuhai, Guangdong 519050
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541199
    China

    Active - Recruiting

  • The First Peoples Hospital of Yulin

    Yulin, Guangxi 537006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Yulin, Guangxi 541199
    China

    Active - Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550001
    China

    Active - Recruiting

  • Cangzhou Central Hospital

    Cangzhou, Hebei 061001
    China

    Active - Recruiting

  • Tangshan Gongren Hosipital

    Tangshan, Hebei 063000
    China

    Active - Recruiting

  • Tangshan Gongren Hospital

    Tangshan, Hebei 063000
    China

    Site Not Available

  • Tangshan Gongren Hospital

    Tangshan City, Hebei 63000
    China

    Active - Recruiting

  • Heilongjiang Provincial Hospital

    Haerbin, Heilongjiang 150036
    China

    Active - Recruiting

  • The Forth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • Huaihe Hospital of Henan University

    Kaifeng, Henan 475000
    China

    Active - Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Active - Recruiting

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan 450018
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • The Seventh Peoples Hospital of Zhengzhou

    Zhengzhou, Henan 450016
    China

    Active - Recruiting

  • The Central Hospital of Wuhan

    Wuhan, Hubei 430014
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Wuhan No 1 Hospital

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Wuhan Third Hospital-Tongren Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • Hunan Provincial Peoples Hospital

    Changsha, Hunan 410005
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • Changshu No1 Peoples Hospital

    Changshu, Jiangsu 215500
    China

    Active - Recruiting

  • Changshu No2 Peoples Hospital

    Changshu, Jiangsu 215523
    China

    Active - Recruiting

  • Nantong First Peoples Hospital

    Nantong, Jiangsu 226000
    China

    Active - Recruiting

  • The First Peoples Hospital of Kunshan

    Suzhou, Jiangsu 215300
    China

    Active - Recruiting

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221006
    China

    Active - Recruiting

  • Jiangxi Provincial People Hospital

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Jiangxi Provincial Peoples Hospital

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Hospital of Nanchang

    Nanchang, Jiangxi 330008
    China

    Active - Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin 13041
    China

    Active - Recruiting

  • The Second Norman Bethune Hospital of Jilin University

    Changchun, Jilin 130041
    China

    Active - Recruiting

  • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)

    Dalian, Liaoning 116000
    China

    Active - Recruiting

  • Dalian Municipal Central Hospital Affiliated Of Dalian Medical University

    Dalian, Liaoning 116000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116000
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116027
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning 121000
    China

    Active - Recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning 110016
    China

    Active - Recruiting

  • The Forth Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110032
    China

    Active - Recruiting

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110032
    China

    Active - Recruiting

  • Shaanxi Provincial Peoples Hospital

    Xi'an, Shaanxi 710068
    China

    Active - Recruiting

  • Tangdu Hospital of Air Force Medical University

    Xi'an, Shaanxi 710038
    China

    Active - Recruiting

  • Tangdu Hospital,Air Force Military Medical University

    Xi'an, Shaanxi 710038
    China

    Active - Recruiting

  • Central Hospital Affiliated To Shandong First Medical University

    Jinan, Shandong 250013
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong 250021
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Active - Recruiting

  • Shandong Qianfoshan Hospital

    Jinan, Shandong 250014
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong 250014
    China

    Active - Recruiting

  • Affiliated hospital of Jining Medical University

    Jining, Shandong 272009
    China

    Active - Recruiting

  • Zibo central Hospital

    Zibo, Shandong 255030
    China

    Active - Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai 200065
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030000
    China

    Active - Recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi An Jiaotong University

    XI An, Shanxi 710061
    China

    Active - Recruiting

  • Shanxi Provincial Peoples Hospital

    Xi'an, Shanxi 710068
    China

    Active - Recruiting

  • Chengdu First Peoples Hospital

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Chengdu Third Peoples Hospital

    Chengdu, Sichuan 61031
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610031
    China

    Active - Recruiting

  • Tianjin First Central Hospital

    Nankai, Tianjin 300384
    China

    Site Not Available

  • Tianjin Chest Hospital

    Tianjin, Tianjin 300222
    China

    Active - Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin 300350
    China

    Active - Recruiting

  • Tianjin Medical University Center Hospital

    Tianjin, Tianjin 300025
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300025
    China

    Active - Recruiting

  • Tianjin Peoples Hospital

    Tianjin, Tianjin 300121
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830054
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • The First Peoples Hospital of Yunnan Province

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Yanan Hospital of Kunming City

    Kunming, Yunnan 473009
    China

    Active - Recruiting

  • Yunnan First Peoples Hospital

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • the First Peoples Hospital of Xiaoshan District Hangzhou

    Hangzhou, Zhejiang 311201
    China

    Active - Recruiting

  • Huzhou Central Hospital

    Huzhou, Zhejiang 310005
    China

    Active - Recruiting

  • The First Peoples Hospital of Huzhou

    Huzhou, Zhejiang 313000
    China

    Active - Recruiting

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang 314000
    China

    Active - Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang 315046
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • Shaoxing Second Hospital

    Shaoxing, Zhejiang 312000
    China

    Active - Recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029
    China

    Active - Recruiting

  • Fuwai Cardiovascular Hospital, Chinese Academy of Medical Sciences

    Beijing, 100037
    China

    Active - Recruiting

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