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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03872401
Other study ID # 20170625
Secondary ID 2018-004565-14
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 11, 2019
Est. completion date July 26, 2025

Study information

Verified date May 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12301
Est. completion date July 26, 2025
Est. primary completion date July 26, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 79 Years
Eligibility Inclusion criteria: 1. Age: Adult subjects = 50 (men) or = 55 (women) to ? 80 years of age (either sex) and meeting lipid criteria 2. Low-density lipoprotein cholesterol (LDL-C) = 90 mg/dL (= 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) = 120 mg/dL (= 3.1 mmol/L), or apolipoprotein B = 80 mg/dL (= 1.56 µmol/L) 3. Evidence of at least one of the following at screening (without prior myocardial infarction or stroke): A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus 4. At least 1 high-risk feature Exclusion criteria - MI or stroke prior to randomization - Coronary artery bypass grafting (CABG) ? 3 months prior to screening - Estimated glomerular filtration rate (eGFR) ? 15 mL/min/1.73 m² - Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator. - Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant) - Triglycerides = 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used. - Last measured left-ventricular ejection fraction ? 30% or New York Heart Association (NYHA) Functional Class III/IV - Planned arterial revascularization

Study Design


Intervention

Drug:
Evolocumab
Administered subcutaneously using an autoinjector pen.
Placebo
Administered subcutaneously using an autoinjector pen.

Locations

Country Name City State
Argentina Instituto de Investigaciones Clinicas Bahia Blanca Bahia Blanca Buenos Aires
Argentina Cardiología Palermo Caba Buenos Aires
Argentina Cedic - Centro de Investigacion Clinica Caba Buenos Aires
Argentina Centro de Especialidades Medicas - Cemedic Caba Buenos Aires
Argentina Centro Medico Dra De Salvo Caba Buenos Aires
Argentina Centro Medico Laura Maffei Caba Buenos Aires
Argentina Cinme - Centro de Investigaciones Metabolicas Caba Buenos Aires
Argentina Ciprec - Centro de Investigacion y Prevencion Cardiovascular Caba Buenos Aires
Argentina Consultorio Medico Dr Litvak Bruno Caba Buenos Aires
Argentina Fundacion Respirar Caba Buenos Aires
Argentina Stat Research Caba Buenos Aires
Argentina Glenny Corp SA Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Hospital Universitario Fundacion Favaloro Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Icba - Instituto Cardiovascular de Buenos Aires Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Instituto de Investigaciones Metabolicas - Idim Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Clinica Privada del Prado Cordoba Córdoba
Argentina Instituto Medico DAMIC - Fundacion Rusculleda Córdoba
Argentina Instituto de Cardiologia de Corrientes Juana Francisca Cabral Corrientes
Argentina Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata Buenos Aires
Argentina Ciad - Consultorio Integral de Atencion al Diabetico Moron Buenos Aires
Argentina Dim Clinica Privada Ramos Mejia Buenos Aires
Argentina Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta Rosario Santa Fe
Argentina Sanatorio Plaza Rosario Santa Fe
Argentina Cordis Sa Salta
Argentina Clinica El Castano San Juan
Argentina Instituto Cardiovascular San Luis San Luis
Argentina Centro Modelo de Cardiologia San Miguel de Tucuman Tucuman
Argentina Clinical Mayo de Urgencias Medicas Cruz Blanca SRL San Miguel de Tucuman Tucuman
Argentina Instituto de Investigaciones Clinicas de San Nicolas San Nicolas Buenos Aires
Argentina Centro de Investigaciones Clinicas del Litoral Santa Fe
Argentina Sanatorio Santa Rosa Srl Santa Rosa La Pampa
Argentina Clinica Fusavim Privada SRL Villa Maria Córdoba
Argentina Instituto de Investigaciones Clinicas Zarate Zarate Buenos Aires
Australia Heart and Vascular Research Adelaide South Australia
Australia Royal Adelaide Hospital Adelaide South Australia
Australia SA Heart Ashford South Australia
Australia Heartcare Partners Auchenflower Queensland
Australia Curtin University Centre of Clinical Research and Education Bentley Western Australia
Australia HeartCare Victoria - Berwick Berwick Victoria
Australia Bundaberg Cardiology Bundaberg Queensland
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Monash Medical Centre Clayton Victoria
Australia The Cardiologists Proprietary Limited Epping Victoria
Australia Holdsworth House Medical Brisbane Fortitude Valley Queensland
Australia Canberra Hospital Garran Australian Capital Territory
Australia Barwon Health Geelong Hospital Geelong Victoria
Australia Royal Hobart Hospital Hobart Tasmania
Australia HeartCare Western Australia - Joondalup Joondalup Western Australia
Australia Adelaide Cardiology Practice - Leabrook Clinic Leabrook South Australia
Australia Liverpool Hospital Liverpool New South Wales
Australia Australian Clinical Research Network Maroubra New South Wales
Australia Core Research Group Pty Ltd Milton Queensland
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia GenesisCare Ringwood Ringwood Victoria
Australia Dr Heart Pty Ltd Woolloongabba
Austria Landeskrankenhaus Feldkirch Feldkirch
Austria Medizinische Universitaet Graz Graz
Austria Medizinische Universitaet Innsbruck Innsbruck
Austria Klinikum Klagenfurt am Woerthersee Klagenfurt
Austria Ordensklinikum Linz Barmherzige Schwestern Linz
Austria Klinik Hietzing Wien
Austria Klinik Landstrasse Wien
Austria Klinik Ottakring Wien
Austria Universitaetsklinikum Allgemeines Krankenhaus Wien Wien
Austria Zentrum fuer klinische Studien - Dr Hanusch GmbH Wien
Belgium Algemeen Stedelijk Ziekenhuis Aalst Aalst
Belgium Onze Lieve Vrouw Ziekenhuis - campus Aalst Aalst
Belgium Ziekenhuis Netwerk Antwerpen Middelheim Antwerpen
Belgium Ziekenhuis Netwerk Antwerpen Stuivenberg Antwerpen
Belgium Universite Catholique de Louvain Cliniques Universitaires Saint Luc Bruxelles
Belgium AZ Sint Blasius Dendermonde
Belgium Algemeen Ziekenhuis Sint Lucas Gent
Belgium Medif sprl Gozee
Belgium Dokter Mortelmans bvba Ham
Belgium Jessa Ziekenhuis - Campus Virga Jesse Hasselt
Belgium Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven
Belgium Medilink sprl Linkebeek
Belgium Centre Hospitalier Universitair Ambroise Pare Mons
Belgium Maria Ziekenhuis Noord-Limburg Pelt
Belgium Testumed vzw Tessenderlo
Brazil Cardresearch Cardiologia Assistencial de Pesquisa Belo Horizonte Minas Gerais
Brazil Fundaçao Hospitalar Sao Francisco de Assis Belo Horizonte Minas Gerais
Brazil AngioCor Blumenau Blumenau Santa Catarina
Brazil Centro de Pesquisa Clinica do Brasil Brasília Distrito Federal
Brazil Sociedade Hospitalar Angelina Caron Campina Grande do Sul Paraná
Brazil Centro Especializado em Cardiologia Campinas São Paulo
Brazil Instituto de Pesquisa Clinica de Campinas Campinas São Paulo
Brazil Nucleo de Pesquisa Clinica Curitiba Paraná
Brazil Puc Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da Pucpr/Epicenter Curitiba Paraná
Brazil Quanta Diagnosticos e Terapia Curitiba Paraná
Brazil Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas Fortaleza Ceará
Brazil Instituto do Coracao de Marilia Marilia São Paulo
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre Rio Grande Do Sul
Brazil Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul
Brazil Núcleo de Pesquisa em Cirurgia Vascular Porto Alegre Rio Grande Do Sul
Brazil IBPClin Instituto Brasil de Pesquisa Clinica Rio de Janeiro
Brazil Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto São José do Rio Preto São Paulo
Brazil Centro de Pesquisas Clinicas Cpclin Sao Paulo São Paulo
Brazil Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo São Paulo
Brazil Eurolatino Pesquisas Medicas Uberlandia Minas Gerais
Bulgaria Ambulatory for special outpatient medical aid in Cardiology-Private Practice Dr Elena Dotcheva EOOD Burgas
Bulgaria Multiprofile Hospital for Active Treatment - Haskovo AD Haskovo
Bulgaria Specialty Hospital for Active treatment in Cardiology Sveti Georgi - Pernik OOD Pernik
Bulgaria Medical Center Medconsult OOD Pleven
Bulgaria University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Pleven
Bulgaria Multiprofile Hospital for Active Treatment- Medical Complex- Sveti Ivan Rilski EOOD Plovdiv
Bulgaria University Multiprofile Hospital for Active Treatment Sveti Georgi EAD Plovdiv
Bulgaria Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD Sofia
Bulgaria Diagnostic-Consultative Center Convex EOOD Sofia
Bulgaria Fifth Multiprofile Hospital for Active Treatment - Sofia EAD Sofia
Bulgaria Medical Center Excelsior OOD Sofia
Bulgaria Medical Center for Specialized Medical Care of Cardiovascular Diseases OOD Sofia
Bulgaria Medical Center Kalimat EOOD Sofia
Bulgaria Multiprofile Hospital for Active Treatment Sveta Anna Sofia AD Sofia
Bulgaria National Multiprofile Transport Hospital Tzar Boris III Sofia
Bulgaria University Multiprofile Hospital for Active Treatment and Emergency Medicine N I Pirogov EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Sofia
Bulgaria Medical Center Orpheus OOD Stara Zagora
Bulgaria Multiprofile Regional Hospital for Active Treatment Dr Stefan Cherkezov AD Veliko Tarnovo
Canada Heart Health Institute Ajax Ontario
Canada LMC Clinical Research Incorporated Barrie Ontario
Canada Brampton Clinical Trials Brampton Ontario
Canada LMC Clinical Research Incorporated Brampton Ontario
Canada LMC Clinical Research Incorporated Calgary Alberta
Canada Ecogene-21 Chicoutimi Quebec
Canada LMC Clinical Research Incorporated Thornhill Concord Ontario
Canada LMC Clinical Research Incorporated Etobicoke Ontario
Canada Queen Elizabeth II Health Sciences Centre, Halifax Infirmary Halifax Nova Scotia
Canada Hamilton Health Sciences Hamilton General Hospital Hamilton Ontario
Canada Manna Research Incorporated Levis Quebec
Canada Western Centre for Public Health and Family Medicine - Western University London Ontario
Canada My Endo Diabetes and Endocrinology Center Markham Ontario
Canada G A Research Associates Limited Moncton New Brunswick
Canada Applied Medical Informatics Research Incorporated Montreal Quebec
Canada Clinique Sante Cardio MC Montreal Quebec
Canada Institut de recherches cliniques de Montreal Montreal Quebec
Canada McGill University Health Centre - Montreal General Hospital Montreal Quebec
Canada Commonwealth Medical Clinic Mount Pearl Newfoundland and Labrador
Canada LMC Clinical Research Incorporated Nepean Ontario
Canada Partners in Advanced Cardiac Evaluation Newmarket Ontario
Canada SKDS Research Incorporated Newmarket Ontario
Canada Oakville Cardiovascular Research Oakville Ontario
Canada Dr James Cha Oshawa Ontario
Canada Kawartha Cardiology Clinical Trials Peterborough Ontario
Canada Clinique des Maladies Lipidiques de Quebec Incorporated Quebec
Canada Bluewater Clinical Research Group Incorporated Sarnia Ontario
Canada Corcare Cardiovascular Research Scarborough Ontario
Canada Heart Health Institute Research Incorporated Scarborough Ontario
Canada Centre intégré de santé et de services sociaux (CISSS) des Laurentides - Unité de recherche clini St Jerome Quebec
Canada SMH Cardiology Clinical Trials Incorporated Surrey British Columbia
Canada North York Diagnostic and Cardiac Centre Toronto Ontario
Canada Womens College Hospital Toronto Ontario
Canada Dr T G Elliott Incorporated - BC Diabetes Vancouver British Columbia
Canada Office of Dr Louis Yao Weston Ontario
Canada Winnipeg Clinic Winnipeg Manitoba
Czechia MUDr Igor Karen Benatky nad Jizerou
Czechia Jessenia as, Nemocnice Beroun Beroun
Czechia Medicentrum Beroun sro Beroun
Czechia Medicus Services sro Brandys nad Labem
Czechia Amkardia sro Brno
Czechia CCR Brno sro Brno
Czechia Centrum pro zdravi sro Brno
Czechia Fakultni nemocnice Brno Brno
Czechia Kardiologicka ambulance Brno sro Brno
Czechia prof MUDr Lubomir Elbl, CSc, Kardiologicka ambulance Brno
Czechia Vojenska nemocnice Brno Brno
Czechia Edumed sro, Kardiologicka ambulance Broumov
Czechia Cevni centrum Ceske Budejovice sro Ceske Budejovice
Czechia Dika centrum sro Havirov - Mesto
Czechia Clinical Trial Center Hodonin sro Hodonin
Czechia Kardio Holesov sro Holesov
Czechia MUDr Ladislava Harrerova, kardiologicka ordinace Hradec Kralove
Czechia Karlovarska krajska nemocnice Karlovy Vary
Czechia Oblastni nemocnice Kladno as Kladno
Czechia Kardio Michal Cepelak sro Klatovy IV
Czechia Oblastni nemocnice Kolin as Kolin III
Czechia Krajska nemocnice Liberec as Liberec
Czechia KardioBusak sro Louny
Czechia Kardio Pudich s.r.o. Ludgerovice
Czechia Vseobecna intermi ambulance sro Milevsko
Czechia MUDr Zbynek Kosek, kardiologicka ambulance sro Mlada Boleslav
Czechia Pozdisek sro, Kardiologicka ambulance Mohelnice
Czechia CCR Ostrava sro Ostrava
Czechia Mestska nemocnice Ostrava Ostrava
Czechia Benedor sro - Kardiologicka, cevni a interni ambulance Ostrava - Poruba
Czechia Kardiologicka a angiologicka ambulance Ostrava-Dubina
Czechia Center for Clinical Research Pardubice, sro Pardubice
Czechia Nemocnice Pardubickeho kraje as Pardubice
Czechia Kardiologie v sadech sro Plzen 1
Czechia Diabet2 sro Praha 1
Czechia Ordinace pro choroby srdce a cev Praha 10
Czechia Kardiologie Cor sro Praha 10 - Zabehlice
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia CCR Prague sro Praha 3
Czechia Milan Kvapil sro Praha 4
Czechia Thomayerova nemocnice Praha 4
Czechia Fakultni nemocnice v Motole Praha 5
Czechia Interni a kardiologicka ordinace Praha 5
Czechia Kardiologicke centrum MUDr Janky Skrobakove sro Praha 5 - Smichov
Czechia Endokrinologie Cerny Most sro Praha 9
Czechia Kardio Vaclavik sro, Interni a kardiologicka ambulance Prerov
Czechia Vestra Clinics sro Rychnov nad Kneznou
Czechia Nemocnice Pardubickeho kraje as, Svitavska nemocnice Svitavy
Czechia AeskuLab ks, Lipidova poradna Teplice
Czechia Nemocnice Podlesi as Trinec
Czechia Clinical Trials Service sro Uherske Hradiste
Czechia Interni ambulance Uherske Hradiste
Czechia Lekarsky dum Ormiga Zlin
Czechia KIGE sro Znojmo
Denmark Aalborg Hospital Aalborg
Denmark Center for Clinical and Basic Research Aalborg Aalborg
Denmark Aarhus Universitetshospital Aarhus N
Denmark Centre for Clinical and Basic Research Ballerup Ballerup
Denmark Sydvestjysk Sygehus Esbjerg
Denmark Sanos Clinic Herlev
Denmark Steno Diabetes Center Herlev
Denmark Regionhospitalet Herning Herning
Denmark Hillerod Hospital Hillerod
Denmark Rigshospitalet Kobenhavn Kobenhavn O
Denmark Amager Hospital Kobenhavn S
Denmark Kolding Sygehus Kolding
Denmark Regionshospitalet Silkeborg Silkeborg
Denmark Svendborg Sygehus Svendborg
Denmark Center for Clinical and Basic Research Vejle Vejle
Denmark Regionshospitalet Viborg Viborg
Estonia Liina Viitas OU Parnu
Estonia Center for Clinical and Basic Research Tallinn Tallinn
Estonia Dr Arvo Rosenthal LLC Tallinn
Estonia North Estonia Medical Centre Foundation Tallinn
Finland GERI-MED Oy Helsinki
Finland Helsinki University Central Hospital Helsinki
Finland Pohjois-Karjalan keskussairaala Joensuu
Finland Studycor Oy Jyvaskyla
Finland Terveystalo Jyvaskyla Jyvaskyla
Finland Satucon Oy/Kuopion tyoterveys Kuopio
Finland University of Eastern Finland Kuopio
Finland Oulu University Hospital Oulu
Finland Oulu University Hospital Oulu
Finland Tampere University Hospital Tampere
Finland Terveystalo Pulssi Turku
France Centre Hospitalier Universitaire Amiens - Hopital Sud Amiens Cedex 1
France Hospices Civils de Lyon Groupement Hospitalier Est, Hopital Louis Pradel Bron
France Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre Caen Cedex 9
France Centre Hospitalier Sud Francilien Corbeil Essonnes
France Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand Dijon
France Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon Grenoble
France Groupement Hospitalier Mutualiste Grenoble
France Centre Hospitalier de Versailles - Hopital Andre Mignot Le Chesnay
France Hopital Louis Pasteur Le Coudray
France Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon Lille
France Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot Lyon Cédex 3
France Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone Marseille cedex 05
France Hopital Saint-Joseph Marseille Cedex 08
France Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve Montpellier cedex 05
France Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec Nantes Cedex 1
France Centre Hospitalier Universitaire de Nice - Hopital Pasteur Nice Cedex 1
France Centre Hospitalier Universitaire de Nimes Nimes
France Hopital Bichat Claude Bernard Paris
France Hopital Europeen Georges Pompidou Paris
France Hopital Pitie-Salpetriere Paris
France Hopital Saint Antoine Paris
France Centre Hospitalier de Pau - Hopital Francois Mitterrand Pau
France Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes
France Clinique Saint Hilaire Rouen
France Clinique Pasteur Toulouse Cedex 3
France Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil Toulouse Cedex 9
France Polyclinique Vauban Valenciennes
Germany Universitaets-Herzzentrum Freiburg - Bad Krozingen Bad Krozingen
Germany Kerckhoff-Klinik Forschungs GmbH Bad Neuheim
Germany Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum Berlin
Germany Klinische Forschung Berlin GbR Berlin
Germany Kardiologisch - Angiologische Praxis - Herzzentrum Bremen Bremen
Germany Sankt-Johannes-Hospital Dortmund
Germany Cardiologicum Dresden und Pirna Dresden
Germany Diabetologische Gemeinschaftspraxis Dr Schaper und Dr Faulmann Dresden
Germany Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik III Dresden
Germany Clin Phenomics GmbH Co KG Frankfurt am Main
Germany Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main Frankfurt am Main
Germany Medizinisches Versorgungszentrum im Altstadt-Carree Fulda Fulda
Germany Cardiologicum Hamburg Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Ambulantes Herzzentrum Kassel Kassel
Germany Universitätsklinikum Leipzig Leipzig
Germany Otto von Guericke Universität Magdeburg Magdeburg
Germany Johannes Gutenberg Universitaet Mainz Mainz
Germany Universitätsklinikum Mannheim Mannheim
Germany Praxis Doktor Jens Taggeselle Markleeberg
Germany Deutsches Herzzentrum München des Freistaates Bayern München
Germany Herz Gefaess Zentrum Nymphenburg München
Germany Universitaetsklinikum Muenster Münster
Germany Kardiologische Gemeinschaftspraxis Papenburg Papenburg
Germany Klinikum Ernst von Bergmann gGmbH Potsdam
Germany Universitätsklinikum Regensburg Regensburg
Germany CardioConsil GmbH Rostock
Germany I Medizinische Klinik Gesundheitsverbund Landkreis Konstanz Singen
Germany Universitätsklinikum Ulm Ulm
Germany Nephrologisches Zentrum Villingen-Schwenningen Villingen-Schwenningen
Germany Forschungszentrum Ruhr Witten
Greece Alexandra Hospital Athens
Greece Athens Naval Hospital Athens
Greece General Hospital of Athens Evaggelismos Athens
Greece General Hospital of Athens Georgios Gennimatas Athens
Greece General Hospital of Athens Ippokrateio Athens
Greece General Hospital of Athens Laiko Athens
Greece Hygeia Hospital Athens
Greece Konstantopoulio - Agia Olga Hospital of Nea Ionia Athens
Greece University Hospital of Heraklion Heraklion
Greece University Hospital of Ioannina Ioannina
Greece University Hospital of Larissa Larissa
Greece Ahepa University Hospital Thessaloniki
Greece General Hospital of Thessaloniki Ahepa Thessaloniki
Greece Interbalkan Medical Center Thessaloniki
Greece Papageorgiou General Hospital of Thessaloniki Thessaloniki
Hungary Lausmed Kft Baja
Hungary Allami Szivkorhaz Balatonfured Balatonfured
Hungary Balatonmariafurdo Kozseg Onkormanyzatanak Haziorvosi Rendeloje Balatonkeresztur
Hungary Med-Edu Bt Balloszog
Hungary Dr Lakatos Ferenc Private Cardiology Practice Bekescsaba
Hungary Grof Tisza Istvan Korhaz Berettyoujfalu
Hungary Bajcsy-Zsilinszky Korhaz es Rendelointezet Budapest
Hungary Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz Budapest
Hungary Clinexpert Kft Budapest
Hungary Gottsegen Gyorgy Orszagos Kardiologiai Intezet Budapest
Hungary Jahn Ferenc Del-pesti Korhaz es Rendelointezet Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Obudai Egeszsegugyi Centrum Kft Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika Budapest
Hungary Uzsoki Utcai Korhaz Budapest
Hungary Zugloi Egeszsegugyi Szolgalat Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Markhot Ferenc Oktatokorhaz es Rendelointezet Eger
Hungary Erzsebet Gondozohaz Godollo
Hungary Bugat Pal Korhaz Gyongyos
Hungary Pharma4 Trial Kft Gyongyos
Hungary Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Gyula
Hungary BKS Research Kft Hatvan
Hungary Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza Kalocsa
Hungary Selye Janos Korhaz Komarom
Hungary Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz Miskolc
Hungary CRU Hungary Kft Miskolc
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont Pecs
Hungary Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet Sopron
Hungary Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar Szeged
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar Szeged
Hungary Praxispont Belvarosi Maganegeszsegugyi Kozpont Szekesfehervar
Hungary Tolna Megyei Balassa Janos Korhaz Szekszard
Hungary Csongrad Megyei Dr Bugyi Istvan Korhaz Szentes
Hungary Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet Szolnok
Hungary Belvarosi Egeszseghaz Kft Zalaegerszeg
Iceland Hjartamidstodin Kopavogur
Iceland Landspitali Reykjavik
Italy Ospedale Muscatello Augusta
Italy Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo
Italy Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi Bologna
Italy Azienda Ospedaliero Universitaria Mater Domini Catanzaro
Italy Universita degli Studi Gabriele D Annunzio di Chieti e Pescara Chieti
Italy Fondazione Toscana Gabriele Monasterio Ospedale del Cuore G Pasquinucci Massa
Italy Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano
Italy Centro Cardiologico Monzino Milano
Italy IRCCS Ospedale San Raffaele Milano
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Presidio Ospedaliero Santa Maria delle Grazie Pozzuoli
Italy Azienda Ospedaliera Sant Andrea Roma
Italy Policlinico Universitario Campus Biomedico Roma
Italy IRCCS Policlinico San Donato San Donato Milanese
Italy Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino
Italy Azienda Ospedaliero Universitaria Integrata di Udine Udine
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Chungbuk National University Hospital Cheongju-si, Chungcheongbuk-do
Korea, Republic of Keimyung University, Dongsan Hospital Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St Marys Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon-si, Gyeonggi-do
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-si, Gangwon-do
Latvia Daugavpils Regional Hospital Daugavpils
Latvia Dace Teterovska Doctor Practice in Endocrinology Ogre
Latvia Inga Jasinkevica Cardiologist Practice Ogre
Latvia Outpatient Clinic Veselibas Centrs 4 Riga
Latvia Pauls Stradins Clinical University Hospital Riga
Lithuania Klinikiniai sprendimai, UAB Alytus
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution Kaunas
Lithuania Klinikiniai sprendimai, UAB Kaunas
Lithuania Saules Seimos Medicinos Centras Kaunas
Lithuania Kardiologijos ir reabilitacijos klinika, UAB Klaipeda
Lithuania Siauliai Republican Hospital, Public Institution Siauliai
Lithuania Vilnius University Hospital Santaros Clinic Public Institution Vilnius
Mexico Centro de investigacion Cardiometabolica Aguascalientes
Mexico Clinstile SA de CV Cd De Mexico Distrito Federal
Mexico Scientia Investigacion Clinica Sc Chihuahua
Mexico Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC Culiacan Sinaloa
Mexico Unidad Biomedica Avanzada Monterrey Monterrey Nuevo León
Mexico Centro de Estudios Clinicos de Queretaro Queretaro Querétaro
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Ziekenhuisgroep Twente Almelo
Netherlands Emotional Brain Almere
Netherlands Meander Medisch Centrum Amersfoort
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Gelre Ziekenhuis Apeldoorn
Netherlands Rijnstate Ziekenhuis Arnhem
Netherlands Rode Kruis Ziekenhuis Beverwijk
Netherlands Amphia ziekenhuis Breda
Netherlands Reinier de Graaf Gasthuis Delft
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United States Louisiana Heart Center Slidell Louisiana
United States Division of Cardiovascular Research at Peconic Bay Medical Center Southampton New York
United States Baystate Health Center Springfield Massachusetts
United States Heart House Research Foundation Springfield Ohio
United States Cardiology Associates of Fairfield County, PC Stamford Connecticut
United States Suffolk Multispecialty Research LLC Suffolk Virginia
United States Palmetto Clinical Research Summerville South Carolina
United States Universal Research Group LLC Tacoma Washington
United States Northwest Houston Heart Center Tomball Texas
United States Harbor University of California Los Angeles Medical Center Torrance California
United States Munson Medical Center Traverse City Michigan
United States Oklahoma Heart Institute Tulsa Oklahoma
United States Virtua Health, Inc. Voorhees New Jersey
United States Aspirus Research Institute Wausau Wisconsin
United States MercyOne Iowa Heart Center West Des Moines Iowa
United States Selma Medical Associates Winchester Virginia
United States Novant Health Forsyth Medical Center Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Florida Cardiology Group Winter Park Florida
United States The Florida Lipid Institute Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Iceland,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (1)

Bohula EA, Marston NA, Ruzza A, Murphy SA, De Ferrari GM, Diaz R, Leiter LA, Elliott-Davey M, Wang H, Bhatia AK, Giugliano RP, Sabatine MS. Rationale and design of the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV) trial. Am Heart J. 2024 Mar;269:179-190. doi: 10.1016/j.ahj.2023.12.004. Epub 2023 Dec 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke Time to coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first. From randomization; for approximately a median of 4.5 years
Primary Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first. From randomization; for approximately a median of 4.5 years
Secondary Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization From randomization; for approximately a median of 4.5 years
Secondary Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization From randomization; for approximately a median of 4.5 years
Secondary Time to Cardiovascular Death, MI, or Ischemic Stroke From randomization; for approximately a median of 4.5 years
Secondary Time to CHD Death or MI From randomization; for approximately a median of 4.5 years
Secondary Time to Myocardial Infarction From randomization; for approximately a median of 4.5 years
Secondary Time to Any Ischemia-driven Arterial Revascularization From randomization; for approximately a median of 4.5 years
Secondary Time to CHD Death From randomization; for approximately a median of 4.5 years
Secondary Time to Cardiovascular Death From randomization; for approximately a median of 4.5 years
Secondary Time to All Cause of Death From randomization; for approximately a median of 4.5 years
Secondary Time to Ischemic Stroke From randomization; for approximately a median of 4.5 years
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