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
- Conditions
- Major Cardiovascular EventEstablished Atherosclerotic Cardiovascular Disease
- Registration Number
- NCT06295679
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7000
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First Up to 72 months
- Secondary Outcome Measures
Name Time Method Time to CV Death, MI, or Stroke, Whichever Occurs First Up to 72 months Percent Change in LDL-C From Baseline Baseline and end of follow-up (up to 72 months) Change in Low-density Lipoprotein Cholesterol (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
Trial Locations
- Locations (89)
The Third Peoples Hospital of Huizhou
🇨🇳Huizhou, Guangdong, China
Zhuhai Peoples Hospital
🇨🇳Zhuhai, Guangdong, China
China Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Fuwai Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Haidian Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chongqing Emergency Medical Center
🇨🇳Chongqing, Chongqing, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Dongguan Songshan Lake Central Hospital
🇨🇳Dong Guan, Guangdong, China
The First Peoples Hospital of Foshan
🇨🇳Foshan, Guangdong, China
The First Affiliated Hospital Sun-Yat Sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Peoples Hospital of Yulin
🇨🇳Yulin, Guangxi, China
The Second Affiliated Hospital of Guilin Medical University
🇨🇳Yulin, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Tangshan Gongren Hospital
🇨🇳Tangshan City, Hebei, China
Heilongjiang Provincial Hospital
🇨🇳Haerbin, Heilongjiang, China
The Fourth Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
The Seventh Peoples Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Fuwai Central China Cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Wuhan No 1 Hospital
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Wuhan Third Hospital-Tongren Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hunan Provincial Peoples Hospital
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Changshu No1 Peoples Hospital
🇨🇳Changshu, Jiangsu, China
Changshu No2 Peoples Hospital
🇨🇳Changshu, Jiangsu, China
Nantong First Peoples Hospital
🇨🇳Nantong, Jiangsu, China
The First Peoples Hospital of Kunshan
🇨🇳Suzhou, Jiangsu, China
Wuxi Peoples Hospital
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Jiangxi Provincial Peoples Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
The Second Norman Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China
The Fourth Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Tangdu Hospital of Air Force Medical University
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial Peoples Hospital
🇨🇳Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
Affiliated hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Zibo central Hospital
🇨🇳Zibo, Shandong, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi An Jiaotong University
🇨🇳XI An, Shanxi, China
Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Chengdu First Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Chengdu Third Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Peoples Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin First Central Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yanan Hospital of Kunming City
🇨🇳Kunming, Yunnan, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Peoples Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
the First Peoples Hospital of Xiaoshan District Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
The First Peoples Hospital of Huzhou
🇨🇳Huzhou, Zhejiang, China
Jiaxing Second Hospital
🇨🇳Jiaxing, Zhejiang, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Shaoxing Second Hospital
🇨🇳Shaoxing, Zhejiang, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China