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
1 other identifier
observational
7,000
1 country
90
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2022
CompletedFirst Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 19, 2028
February 20, 2026
February 1, 2026
6 years
February 26, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First
Up to 72 months
Secondary Outcomes (5)
Time to CV Death, MI, or Stroke, Whichever Occurs First
Up to 72 months
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
Baseline and end of follow-up (up to 72 months)
Percent Change in LDL-C From Baseline
Baseline and end of follow-up (up to 72 months)
Number of Participants Who Experienced Adverse Events
Up to 72 months
Number of Participants Who Experienced Adverse Drug Reactions
Up to 72 months
Study Arms (2)
Repatha® with Standard of Care Exposure
Participants with clinically evident ASCVD treated with Repatha® in combination with SOC in a clinical setting. To ensure that the recruitment strategy has as little impact on routine practice as possible, the decision to treat the participant with Repatha® with SOC will be made independently of, and before, enrollment in the study.
Standard of Care Exposure
Participants with clinically evident ASCVD treated with SOC alone in a clinical setting. To ensure that the recruitment strategy has as little impact on routine practice as possible, the decision to treat the participant with SOC only will be made independently of, and before, enrollment in the study.
Eligibility Criteria
The study population comprises Chinese participants with established ASCVD treated with Repatha® in combination with SOC or with SOC alone in a clinical setting which includes any primary through tertiary healthcare setting where Repatha® is prescribed.
You may qualify if:
- 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.
- Already received SOC treatment prior to enrollment.
- Participants with ANY of the following.
- Diagnosis of MI OR stroke within 2 years before enrollment.
- 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.
You may not qualify if:
- 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 9 inhibition treatments within past 6 months prior to enrollment.
- Participants currently enrolled in another study involving any investigational procedure, device or drug.
- Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (90)
China Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100086, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, 400014, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 401121, China
Dongguan Songshan Lake Central Hospital
Dongguan, Guangdong, 523127, China
The First Peoples Hospital of Foshan
Foshan, Guangdong, 528000, China
The First Affiliated Hospital Sun-Yat Sen University
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Shantou University Medical College
Guangzhou, Guangdong, 510280, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
The Sixth Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
The Third Peoples Hospital of Huizhou
Huizhou, Guangdong, 516002, China
Zhuhai Peoples Hospital
Zhuhai, Guangdong, 519050, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541199, China
The First Peoples Hospital of Yulin
Yulin, Guangxi, 537006, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061001, China
Tangshan Gongren Hospital
Tangshan, Hebei, 63000, China
Heilongjiang Provincial Hospital
Haerbin, Heilongjiang, 150036, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
The Seventh Peoples Hospital of Zhengzhou
Zhengzhou, Henan, 450016, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450018, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Wuhan No 1 Hospital
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Wuhan Third Hospital-Tongren Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hunan Provincial Peoples Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Changshu No1 Peoples Hospital
Changshu, Jiangsu, 215500, China
Changshu No2 Peoples Hospital
Changshu, Jiangsu, 215523, China
Nantong First Peoples Hospital
Nantong, Jiangsu, 226000, China
The First Peoples Hospital of Kunshan
Suzhou, Jiangsu, 215300, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
Jiangxi Provincial Peoples Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Nanchang
Nanchang, Jiangxi, 330008, China
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, 130041, China
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
Dalian, Liaoning, 116000, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110032, China
Tangdu Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038, China
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014, China
Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021, China
Affiliated hospital of Jining Medical University
Jining, Shandong, 272009, China
Zibo central Hospital
Zibo, Shandong, 255030, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The First Affiliated Hospital of Xi An Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610031, China
Chengdu First Peoples Hospital
Chengdu, Sichuan, 610041, China
Chengdu Third Peoples Hospital
Chengdu, Sichuan, 61031, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300025, China
Tianjin Peoples Hospital
Tianjin, Tianjin Municipality, 300120, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300350, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yanan Hospital of Kunming City
Kunming, Yunnan, 473009, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First Peoples Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
the First Peoples Hospital of Xiaoshan District Hangzhou
Hangzhou, Zhejiang, 311201, China
Huzhou Central Hospital
Huzhou, Zhejiang, 310005, China
The First Peoples Hospital of Huzhou
Huzhou, Zhejiang, 313000, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, 314000, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315046, China
Shaoxing Second Hospital
Shaoxing, Zhejiang, 312000, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2024
First Posted
March 6, 2024
Study Start
December 19, 2022
Primary Completion (Estimated)
December 19, 2028
Study Completion (Estimated)
December 19, 2028
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.