164
Participants
Start Date
November 19, 2018
Primary Completion Date
December 18, 2020
Study Completion Date
January 21, 2021
Evolocumab
Participants will receive evolocumab (AMG 145) subcutaneous monthly.
Placebo
Participants will receive matching placebo subcutaneous monthly.
Statin therapy
"high-intensity statin treatment with atorvastatin ≥ 40 mg daily or equivalent as background therapy~Investigators will up-titrate statin therapy to the maximally tolerated dose, in accordance with local guidelines, prior to randomization."
Semmelweis Egyetem, Budapest
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest
Royal Prince Alfred Hospital, Camperdown
Royal North Shore Hospital, St Leonards
The Northern Hospital, Epping
Monash Medical Centre, Clayton
Royal Adelaide Hospital, Adelaide
Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs
Allami Szivkorhaz Balatonfured, Balatonfüred
Azienda Ospedaliera Santa Croce e Carle, Cuneo
Charite Universitätsmedizin Berlin Campus Benjamin Franklin, Berlin
Medstar Heart and Vascular Institute, Washington D.C.
IRCCS Istituto Clinico Humanitas, Rozzano MI
IRCCS Centro Cardiologico Monzino, Milan
Universitäres Herzzentrum Hamburg GmbH, Hamburg
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo
University Hospitals Cleveland Medical Center, Cleveland
Midwest Cardiovascular Research And Education Foundation, Elkhart
Azienda Ospedaliera Universitaria Careggi, Florence
Saint Louis University Hospital, St Louis
Azienda Ospedaliera Universitaria Federico II, Napoli
Deutsches Herzzentrum München des Freistaates Bayern, München
University of California at Los Angeles, Los Angeles
Fakultni nemocnice Brno, Brno
Fakultni nemocnice Hradec Kralove, Hradec Králové
Azienda Ospedaliera San Giovanni Addolorata, Roma
Noordwest Ziekenhuisgroep, Alkmaar
Vrjie Universiteit Medisch Centrum, Amsterdam
Onze Lieve Vrouwe Gasthuis, Amsterdam
Radboud Universitair Medisch Centrum, Nijmegen
Canisius-Wilhelmina Ziekenhuis, Nijmegen
Elisabeth-TweeSteden Ziekenhuis, Tilburg
Isala Klinieken, Zwolle
Lead Sponsor
Amgen
INDUSTRY