Clinical trial NCT06295679: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Cardiovascular Event
Established Atherosclerotic Cardiovascular Disease
Keywords: Cardiovascular death
Myocardial infarction
Stroke
Unstable angina
Coronary revascularization
Atherosclerotic Cardiovascular Disease
Repatha
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First
timeFrame: Up to 72 months
Secondary outcomes:
measure: Time to CV Death, MI, or Stroke, Whichever Occurs First
timeFrame: Up to 72 months
measure: Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
timeFrame: Baseline and end of follow-up (up to 72 months)
measure: Percent Change in LDL-C From Baseline
timeFrame: Baseline and end of follow-up (up to 72 months)
measure: Number of Participants Who Experienced Adverse Events
timeFrame: Up to 72 months
measure: Number of Participants Who Experienced Adverse Drug Reactions
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Haidian Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Emergency Medical Center
state: Chongqing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Dong Guan
country: China
facility: Dongguan Songshan Lake Central Hospital
state: Guangdong
city: Foshan
country: China
facility: The First Peoples Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun-Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Huizhou
country: China
facility: The Third Peoples Hospital of Huizhou
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai Peoples Hospital
state: Guangdong
city: Yulin
country: China
facility: The First Peoples Hospital of Yulin
state: Guangxi
city: Yulin
country: China
facility: The Second Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Tangshan City
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Haerbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Hospital of Harbin Medical University
state: Heilongjiang
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Seventh Peoples Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan No 1 Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Third Hospital-Tongren Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial Peoples Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changshu
country: China
facility: Changshu No1 Peoples Hospital
state: Jiangsu
city: Changshu
country: China
facility: Changshu No2 Peoples Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong First Peoples Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Peoples Hospital of Kunshan
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Peoples Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Peoples Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The First Hospital of Nanchang
state: Jiangxi
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Tangdu Hospital of Air Force Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial Peoples Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Jining
country: China
facility: Affiliated hospital of Jining Medical University
state: Shandong
city: Zibo
country: China
facility: Zibo central Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: XI An
country: China
facility: The First Affiliated Hospital of Xi An Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu First Peoples Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Third Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Peoples Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yanan Hospital of Kunming City
state: Yunnan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The First Peoples Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: the First Peoples Hospital of Xiaoshan District Hangzhou
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Huzhou
country: China
facility: The First Peoples Hospital of Huzhou
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Second Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: