protocolSection identificationModule nctId: NCT06295679, orgStudyIdInfo id: 20180442, briefTitle: 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-19, primaryCompletionDateStruct date: 2028-12-19, completionDateStruct date: 2028-12-19, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Major Cardiovascular Event, conditions: Established Atherosclerotic Cardiovascular Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 7000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First, secondaryOutcomes measure: Time to CV Death, MI, or Stroke, Whichever Occurs First, secondaryOutcomes measure: Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline, secondaryOutcomes measure: Percent Change in LDL-C From Baseline, secondaryOutcomes measure: Number of Participants Who Experienced Adverse Events, secondaryOutcomes measure: Number of Participants Who Experienced Adverse Drug Reactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 150 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Japan Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Haidian Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100086, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing Emergency Medical Center, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400014, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Chongqing General Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 401121, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Dongguan Songshan Lake Central Hospital, status: RECRUITING, city: Dong Guan, state: Guangdong, zip: 523127, country: China, locations facility: The First Peoples Hospital of Foshan, status: RECRUITING, city: Foshan, state: Guangdong, zip: 528000, country: China, geoPoint lat: 23.02677, lon: 113.13148, locations facility: The First Affiliated Hospital of Shantou University Medical College, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Jinan University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Peoples Hospital of Huizhou City, status: RECRUITING, city: Huizhou, state: Guangdong, zip: 516002, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Zhuhai Peoples Hospital, status: RECRUITING, city: Zhuhai, state: Guangdong, zip: 519050, country: China, geoPoint lat: 22.27694, lon: 113.56778, locations facility: The First Peoples Hospital of Yulin, status: RECRUITING, city: Yulin, state: Guangxi, zip: 537006, country: China, geoPoint lat: 22.63333, lon: 110.15, locations facility: The Second Affiliated Hospital of Guilin Medical University, status: RECRUITING, city: Yulin, state: Guangxi, zip: 541199, country: China, geoPoint lat: 22.63333, lon: 110.15, locations facility: The Affiliated Hospital of Guizhou Medical University, status: RECRUITING, city: Guiyang, state: Guizhou, zip: 550001, country: China, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Cangzhou Central Hospital, status: RECRUITING, city: Cangzhou, state: Hebei, zip: 061001, country: China, geoPoint lat: 38.31667, lon: 116.86667, locations facility: Tangshan Gongren Hosipital, status: RECRUITING, city: Tangshan, state: Hebei, zip: 063000, country: China, geoPoint lat: 39.63333, lon: 118.18333, locations facility: Heilongjiang Provincial Hospital, status: RECRUITING, city: Haerbin, state: Heilongjiang, zip: 150036, country: China, geoPoint lat: 31.8696, lon: 101.742, locations facility: Huaihe Hospital of Henan University, status: RECRUITING, city: Kaifeng, state: Henan, zip: 475000, country: China, geoPoint lat: 34.7986, lon: 114.30742, locations facility: Nanyang Central Hospital, status: RECRUITING, city: Nanyang, state: Henan, zip: 473000, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: The Seventh Peoples Hospital of Zhengzhou, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450016, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Central Hospital of Wuhan, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430014, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Union Hospital Tongji Medical College Huazhong University of science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan No 1 Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Third Hospital-Tongren Hospital Of Wuhan University, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Provincial Peoples Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410005, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Changshu No1 Peoples Hospital, status: RECRUITING, city: Changshu, state: Jiangsu, zip: 215500, country: China, geoPoint lat: 29.44395, lon: 118.88005, locations facility: Changshu NO2 Peoples Hospital, status: RECRUITING, city: Changshu, state: Jiangsu, zip: 215523, country: China, geoPoint lat: 29.44395, lon: 118.88005, locations facility: Nantong First Peoples Hospital, status: RECRUITING, city: Nantong, state: Jiangsu, zip: 226000, country: China, geoPoint lat: 32.03028, lon: 120.87472, locations facility: The first peoples hospital of Kunshan, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215300, country: China, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Wuxi Peoples Hospital, status: RECRUITING, city: Wuxi, state: Jiangsu, zip: 214023, country: China, geoPoint lat: 31.56887, lon: 120.28857, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221006, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Jiangxi Provincial People Hospital, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The first affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The First Hospital of Nanchang, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330008, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: The Second Hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, zip: 13041, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Dalian Municipal Central Hospital Affiliated Of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116000, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The First Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116000, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The Second Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116027, country: China, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The First Affiliated Hospital of Jinzhou Medical University, status: RECRUITING, city: Jinzhou, state: Liaoning, zip: 121000, country: China, geoPoint lat: 41.10778, lon: 121.14167, locations facility: General Hospital of Northern Theater Command, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110016, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The Forth Affiliated Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110032, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Tangdu Hospital,Air Force Military Medical University, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710038, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Shaanxi Provincial Peoples Hospital, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710068, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong Qianfoshan Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250014, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong Provincial Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250021, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Affiliated hospital of Jining Medical University, status: RECRUITING, city: Jining, state: Shandong, zip: 272009, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: Zibo central Hospital, status: RECRUITING, city: Zibo, state: Shandong, zip: 255030, country: China, geoPoint lat: 36.79056, lon: 118.06333, locations facility: Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200092, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Hospital of Shanxi Medical University, status: RECRUITING, city: Taiyuan, state: Shanxi, zip: 030001, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: The First Affiliated Hospital of Xi An Jiaotong University, status: RECRUITING, city: XI An, state: Shanxi, zip: 710061, country: China, locations facility: Chengdu First Peoples Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Chengdu Third Peoples Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 61031, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Tianjin Peoples Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300120, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tianjin Chest Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300222, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital of Xinjiang Medical University, status: RECRUITING, city: Urumqi, state: Xinjiang, zip: 830054, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Yanan Hospital of Kunming City, status: RECRUITING, city: Kunming, state: Yunnan, zip: 473009, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: First Affiliated Hospital of Kunming Medical University, status: RECRUITING, city: Kunming, state: Yunnan, zip: 650032, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Yunnan First Peoples Hospital, status: RECRUITING, city: Kunming, state: Yunnan, zip: 650032, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: the First Peoples Hospital of Xiaoshan District Hangzhou, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 311201, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, state: Zhejiang, zip: 310005, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: The First Peoples Hospital of Huzhou, status: RECRUITING, city: Huzhou, state: Zhejiang, zip: 313000, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: Jiaxing Second Hospital, status: RECRUITING, city: Jiaxing, state: Zhejiang, zip: 314000, country: China, geoPoint lat: 30.7522, lon: 120.75, locations facility: The first affiliated hospital of Ningbo university, status: RECRUITING, city: Ningbo, state: Zhejiang, zip: 315010, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ningbo medical center lihuili hospital, status: RECRUITING, city: Ningbo, state: Zhejiang, zip: 315046, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Shaoxing Second Hospital, status: RECRUITING, city: Shaoxing, state: Zhejiang, zip: 312000, country: China, geoPoint lat: 30.00237, lon: 120.57864, locations facility: Beijing Anzhen Hospital, Capital Medical University, status: RECRUITING, city: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Tongji Hospital of Tongji University, status: RECRUITING, city: Shanghai, zip: 200065, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False