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

Status: Recruiting
Location: See all (90) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 150
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Haidian Hospital
RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
China Japan Friendship Hospital
RECRUITING
Beijing
Fuwai Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Cangzhou Central Hospital
RECRUITING
Cangzhou
The Second Norman Bethune Hospital of Jilin University
RECRUITING
Changchun
Hunan Provincial Peoples Hospital
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
Changshu No1 Peoples Hospital
RECRUITING
Changshu
Changshu No2 Peoples Hospital
RECRUITING
Changshu
Chengdu First Peoples Hospital
RECRUITING
Chengdu
Chengdu Third Peoples Hospital
RECRUITING
Chengdu
Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Chongqing Emergency Medical Center
RECRUITING
Chongqing
Chongqing General Hospital
RECRUITING
Chongqing
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
RECRUITING
Dalian
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Dongguan Songshan Lake Central Hospital
RECRUITING
Dongguan
The First Peoples Hospital of Foshan
RECRUITING
Foshan
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Jinan University
RECRUITING
Guangzhou
The First Affiliated Hospital of Shantou University Medical College
RECRUITING
Guangzhou
The First Affiliated Hospital Sun-Yat Sen University
RECRUITING
Guangzhou
The Sixth Affiliated Hospital Sun Yat-sen University
RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guilin Medical University
RECRUITING
Guilin
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Heilongjiang Provincial Hospital
RECRUITING
Haerbin
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
RECRUITING
Hangzhou
the First Peoples Hospital of Xiaoshan District Hangzhou
RECRUITING
Hangzhou
The Fourth Hospital of Harbin Medical University
RECRUITING
Harbin
The Third Peoples Hospital of Huizhou
RECRUITING
Huizhou
Huzhou Central Hospital
RECRUITING
Huzhou
The First Peoples Hospital of Huzhou
RECRUITING
Huzhou
Jiaxing Second Hospital
RECRUITING
Jiaxing
Jinan Central Hospital
RECRUITING
Jinan
Provincial Hospital Affiliated to Shandong First Medical University
RECRUITING
Jinan
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of Shandong First Medical University
RECRUITING
Jinan
Affiliated hospital of Jining Medical University
RECRUITING
Jining
The First Affiliated Hospital of Jinzhou Medical University
RECRUITING
Jinzhou
Huaihe Hospital of Henan University
RECRUITING
Kaifeng
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First Peoples Hospital of Yunnan Province
RECRUITING
Kunming
Yanan Hospital of Kunming City
RECRUITING
Kunming
Jiangxi Provincial Peoples Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Hospital of Nanchang
RECRUITING
Nanchang
Nantong First Peoples Hospital
RECRUITING
Nantong
Nanyang Central Hospital
RECRUITING
Nanyang
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shaoxing Second Hospital
RECRUITING
Shaoxing
General Hospital of Northern Theater Command
RECRUITING
Shenyang
The Fourth Affiliated Hospital of China Medical University
RECRUITING
Shenyang
The First Peoples Hospital of Kunshan
RECRUITING
Suzhou
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
The Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tangshan Gongren Hospital
RECRUITING
Tangshan
Tianjin Chest Hospital
RECRUITING
Tianjin
Tianjin First Central Hospital
RECRUITING
Tianjin
Tianjin First Central Hospital
RECRUITING
Tianjin
Tianjin Huanhu Hospital
RECRUITING
Tianjin
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Tianjin Peoples Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
The Central Hospital of Wuhan
RECRUITING
Wuhan
Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Wuhan No 1 Hospital
RECRUITING
Wuhan
Wuhan Third Hospital-Tongren Hospital of Wuhan University
RECRUITING
Wuhan
Wuxi Peoples Hospital
RECRUITING
Wuxi
Shaanxi Provincial Peoples Hospital
RECRUITING
Xi'an
Tangdu Hospital of Air Force Medical University
RECRUITING
Xi'an
The First Affiliated Hospital of Xi An Jiaotong University
RECRUITING
Xi’an
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
The First Peoples Hospital of Yulin
RECRUITING
Yulin
Fuwai Central China Cardiovascular Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
The Seventh Peoples Hospital of Zhengzhou
RECRUITING
Zhengzhou
Zhuhai Peoples Hospital
RECRUITING
Zhuhai
Zibo central Hospital
RECRUITING
Zibo
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2028-12-19
Participants
Target number of participants: 7000
Treatments
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.
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov