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Major Cardiovascular EventNCT06295679

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

An observational study of Major Cardiovascular Event and Established Atherosclerotic Cardiovascular Disease, run by Amgen at 90 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 150 years
How many people
7,000 participants
Where
90 sitesChina
Study dates
19 Dec 2022to 19 Dec 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 150 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

China90 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • China Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Haidian Hospital

    Beijing, Beijing Municipality, 100086

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061001

  • The Second Norman Bethune Hospital of Jilin University

    Changchun, Jilin, 130041

  • Hunan Provincial Peoples Hospital

    Changsha, Hunan, 410005

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Changshu No1 Peoples Hospital

    Changshu, Jiangsu, 215500

  • Changshu No2 Peoples Hospital

    Changshu, Jiangsu, 215523

  • Sichuan Academy of Medical Sciences Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610031

  • Chengdu First Peoples Hospital

    Chengdu, Sichuan, 610041

  • Chengdu Third Peoples Hospital

    Chengdu, Sichuan, 61031

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing Municipality, 400014

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 401121

  • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)

    Dalian, Liaoning, 116000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116027

  • Dongguan Songshan Lake Central Hospital

    Dongguan, Guangdong, 523127

  • The First Peoples Hospital of Foshan

    Foshan, Guangdong, 528000

  • The First Affiliated Hospital Sun-Yat Sen University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Shantou University Medical College

    Guangzhou, Guangdong, 510280

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • The Sixth Affiliated Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541199

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550001

  • Heilongjiang Provincial Hospital

    Haerbin, Heilongjiang, 150036

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • the First Peoples Hospital of Xiaoshan District Hangzhou

    Hangzhou, Zhejiang, 311201

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Third Peoples Hospital of Huizhou

    Huizhou, Guangdong, 516002

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 310005

  • The First Peoples Hospital of Huzhou

    Huzhou, Zhejiang, 313000

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang, 314000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250014

  • Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021

  • Affiliated hospital of Jining Medical University

    Jining, Shandong, 272009

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121000

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475000

  • Yanan Hospital of Kunming City

    Kunming, Yunnan, 473009

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • The First Peoples Hospital of Yunnan Province

    Kunming, Yunnan, 650032

  • Jiangxi Provincial Peoples Hospital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The First Hospital of Nanchang

    Nanchang, Jiangxi, 330008

  • Nantong First Peoples Hospital

    Nantong, Jiangsu, 226000

  • Nanyang Central Hospital

    Nanyang, Henan, 473000

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315046

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shaoxing Second Hospital

    Shaoxing, Zhejiang, 312000

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110016

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110032

  • The First Peoples Hospital of Kunshan

    Suzhou, Jiangsu, 215300

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 63000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300025

  • Tianjin Peoples Hospital

    Tianjin, Tianjin Municipality, 300120

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300192

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300350

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300384

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Wuhan No 1 Hospital

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Wuhan Third Hospital-Tongren Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023

  • Tangdu Hospital of Air Force Medical University

    Xi'an, Shaanxi, 710038

  • Shaanxi Provincial Peoples Hospital

    Xi'an, Shaanxi, 710068

  • The First Affiliated Hospital of Xi An Jiaotong University

    Xi’an, Shanxi, 710061

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • The First Peoples Hospital of Yulin

    Yulin, Guangxi, 537006

  • The Seventh Peoples Hospital of Zhengzhou

    Zhengzhou, Henan, 450016

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 450018

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Zhuhai Peoples Hospital

    Zhuhai, Guangdong, 519050

  • Zibo central Hospital

    Zibo, Shandong, 255030

Other trials in China

About this study

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

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.

Keywords
Cardiovascular death, Myocardial infarction, Stroke, Unstable angina, Coronary revascularization, Atherosclerotic Cardiovascular Disease, Repatha
Medical subject headings
Myocardial Infarction, Stroke, Angina, Unstable, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06295679
Study groupRoleWhat they receive
Repatha® with Standard of Care ExposureParticipants 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 ExposureParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First

    Measured: Up to 72 months

Secondary outcomes (5)

  1. Time to CV Death, MI, or Stroke, Whichever Occurs First

    Measured: Up to 72 months

  2. Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline

    Measured: Baseline and end of follow-up (up to 72 months)

  3. Percent Change in LDL-C From Baseline

    Measured: Baseline and end of follow-up (up to 72 months)

  4. Number of Participants Who Experienced Adverse Events

    Measured: Up to 72 months

  5. Number of Participants Who Experienced Adverse Drug Reactions

    Measured: Up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start19 Dec 2022
  3. Primary completion19 Dec 2028 (estimated)
  4. Study completion19 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
7,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295679
Sponsor's protocol ID
20180442
Status last verified
Sep 2026
First submitted
26 Feb 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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