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

September 3, 2026 updated by: Amgen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

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.
Observational

Enrollment (Actual)

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.
7000

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 100029
        • China Japan Friendship Hospital
      • Beijing, Beijing Municipality, China, 100029
        • Beijing AnZhen Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 100037
        • Fuwai Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, China, 100086
        • Beijing Haidian Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 401121
        • Chongqing General Hospital
      • Chongqing, Chongqing Municipality, China, 400014
        • Chongqing Emergency Medical Center
    • Guangdong
      • Dongguan, Guangdong, China, 523127
        • Dongguan Songshan Lake Central Hospital
      • Foshan, Guangdong, China, 528000
        • The First Peoples Hospital of Foshan
      • Guangzhou, Guangdong, China, 510630
        • The third affiliated hospital of Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510630
        • The First Affiliated Hospital of Jinan University
      • Guangzhou, Guangdong, China, 510280
        • ZhuJiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital Southern Medical University
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital Sun-Yat Sen University
      • Guangzhou, Guangdong, China, 510280
        • the First Affiliated Hospital of Shantou University Medical College
      • Huizhou, Guangdong, China, 516002
        • The Third Peoples Hospital of Huizhou
      • Zhuhai, Guangdong, China, 519050
        • Zhuhai Peoples Hospital
    • Guangxi
      • Guilin, Guangxi, China, 541199
        • The Second Affiliated Hospital of Guilin Medical University
      • Yulin, Guangxi, China, 537006
        • The First Peoples Hospital of Yulin
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • The Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Cangzhou, Hebei, China, 061001
        • Cangzhou Central Hospital
      • Tangshan, Hebei, China, 63000
        • Tangshan Gongren Hospital
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150036
        • Heilongjiang Provincial Hospital
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Hospital of Harbin Medical University
    • Henan
      • Kaifeng, Henan, China, 475000
        • Huaihe Hospital of Henan University
      • Nanyang, Henan, China, 473000
        • Nanyang Central Hospital
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450016
        • The Seventh Peoples Hospital of Zhengzhou
      • Zhengzhou, Henan, China, 450018
        • Fuwai Central China Cardiovascular Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430014
        • The Central Hospital of Wuhan
      • Wuhan, Hubei, China, 430022
        • Wuhan No 1 Hospital
      • Wuhan, Hubei, China, 430060
        • Wuhan Third Hospital-Tongren Hospital of Wuhan University
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410005
        • Hunan Provincial Peoples Hospital
    • Jiangsu
      • Changshu, Jiangsu, China, 215500
        • Changshu No1 Peoples Hospital
      • Changshu, Jiangsu, China, 215523
        • Changshu No2 Peoples Hospital
      • Nantong, Jiangsu, China, 226000
        • Nantong First Peoples Hospital
      • Suzhou, Jiangsu, China, 215300
        • The First Peoples Hospital of Kunshan
      • Wuxi, Jiangsu, China, 214023
        • Wuxi Peoples Hospital
      • Xuzhou, Jiangsu, China, 221006
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330008
        • The First Hospital of Nanchang
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial Peoples Hospital
    • Jilin
      • Changchun, Jilin, China, 130041
        • The Second Norman Bethune Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • The Second Hospital of Dalian Medical University
      • Dalian, Liaoning, China, 116000
        • The First Affiliated Hospital of Dalian Medical University
      • Dalian, Liaoning, China, 116000
        • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
      • Jinzhou, Liaoning, China, 121000
        • The First Affiliated Hospital of Jinzhou Medical University
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command
      • Shenyang, Liaoning, China, 110032
        • The Fourth Affiliated Hospital of China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial Peoples Hospital
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital of Air Force Medical University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
      • Jinan, Shandong, China, 250014
        • The First Affiliated Hospital of Shandong First Medical University
      • Jinan, Shandong, China, 250021
        • Provincial Hospital Affiliated to Shandong First Medical University
      • Jining, Shandong, China, 272009
        • Affiliated Hospital of Jining Medical University
      • Zibo, Shandong, China, 255030
        • Zibo Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Tongji Hospital of Tongji University
      • Shanghai, Shanghai Municipality, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • First Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China, 030001
        • The Second Hospital of Shanxi Medical University
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi An JiaoTong University
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital
      • Chengdu, Sichuan, China, 610041
        • Chengdu First Peoples Hospital
      • Chengdu, Sichuan, China, 61031
        • Chengdu Third Peoples Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300192
        • Tianjin First Central Hospital
      • Tianjin, Tianjin Municipality, China, 300350
        • Tianjin Huanhu Hospital
      • Tianjin, Tianjin Municipality, China, 300222
        • Tianjin Chest Hospital
      • Tianjin, Tianjin Municipality, China, 300120
        • Tianjin Peoples Hospital
      • Tianjin, Tianjin Municipality, China, 300384
        • Tianjin First Central Hospital
      • Tianjin, Tianjin Municipality, China, 300025
        • Tianjin Medical University General Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
      • Kunming, Yunnan, China, 473009
        • Yanan Hospital of Kunming City
      • Kunming, Yunnan, China, 650032
        • The First Peoples Hospital of Yunnan Province
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 311201
        • the First Peoples Hospital of Xiaoshan District Hangzhou
      • Huzhou, Zhejiang, China, 310005
        • Huzhou Central Hospital
      • Huzhou, Zhejiang, China, 313000
        • The First Peoples Hospital of Huzhou
      • Jiaxing, Zhejiang, China, 314000
        • Jiaxing Second Hospital
      • Ningbo, Zhejiang, China, 315046
        • Ningbo Medical Center Lihuili Hospital
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University
      • Shaoxing, Zhejiang, China, 312000
        • Shaoxing Second Hospital

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

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

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 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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

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
Time Frame
Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First
Time Frame: Up to 72 months
Up to 72 months

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
Time Frame
Time to CV Death, MI, or Stroke, Whichever Occurs First
Time Frame: Up to 72 months
Up to 72 months
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
Time Frame: Baseline and end of follow-up (up to 72 months)
Baseline and end of follow-up (up to 72 months)
Percent Change in LDL-C From Baseline
Time Frame: Baseline and end of follow-up (up to 72 months)
Baseline and end of follow-up (up to 72 months)
Number of Participants Who Experienced Adverse Events
Time Frame: Up to 72 months
Up to 72 months
Number of Participants Who Experienced Adverse Drug Reactions
Time Frame: Up to 72 months
Up to 72 months

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.
Amgen

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.
  • Study Director: MD, Amgen

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.

Helpful Links

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 (Actual)

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.
December 19, 2022

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.
December 19, 2028

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.
December 19, 2028

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).
February 26, 2024

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.
March 4, 2024

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.
March 6, 2024

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.
September 4, 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.
September 3, 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.
September 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.
  • 20180442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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