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Active, not recruiting Observational

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

NCT06295679 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Observational
Started
2022-12-19
Last updated
2026-09-04

Condition(s) studied

Major Cardiovascular EventEstablished Atherosclerotic Cardiovascular Disease

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

Sex
ALL
Min age
18 Years
Max age
150 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (90)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality
China Japan Friendship Hospital Beijing Beijing Municipality
Peking University First Hospital Beijing Beijing Municipality
Fuwai Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Haidian Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Beijing Hospital Beijing Beijing Municipality
Chongqing Emergency Medical Center Chongqing Chongqing Municipality
Chongqing General Hospital Chongqing Chongqing Municipality
Dongguan Songshan Lake Central Hospital Dongguan Guangdong
The First Peoples Hospital of Foshan Foshan Guangdong
The First Affiliated Hospital Sun-Yat Sen University Guangzhou Guangdong
The First Affiliated Hospital of Shantou University Medical College Guangzhou Guangdong
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Nanfang Hospital Southern Medical University Guangzhou Guangdong
The First Affiliated Hospital of Jinan University Guangzhou Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
The Sixth Affiliated Hospital Sun Yat-sen University Guangzhou Guangdong
The Third Peoples Hospital of Huizhou Huizhou Guangdong
Zhuhai Peoples Hospital Zhuhai Guangdong
The Second Affiliated Hospital of Guilin Medical University Guilin Guangxi
The First Peoples Hospital of Yulin Yulin Guangxi
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
Cangzhou Central Hospital Cangzhou Hebei
Tangshan Gongren Hospital Tangshan Hebei
Heilongjiang Provincial Hospital Haerbin Heilongjiang
The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
Huaihe Hospital of Henan University Kaifeng Henan
Nanyang Central Hospital Nanyang Henan
The Seventh Peoples Hospital of Zhengzhou Zhengzhou Henan
Fuwai Central China Cardiovascular Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
The Central Hospital of Wuhan Wuhan Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Wuhan No 1 Hospital Wuhan Hubei
Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology Wuhan Hubei
Wuhan Third Hospital-Tongren Hospital of Wuhan University Wuhan Hubei
Hunan Provincial Peoples Hospital Changsha Hunan
Xiangya Hospital Central South University Changsha Hunan

+ 50 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06295679 on ClinicalTrials.gov ↗ ← All trials in China