Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

Dyslipidemia Clinical Trial

— FOURIER  

Official title:

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764633
• Other study ID #: 20110118
• Secondary ID: 2014/01/00432420
• Status: Completed
• Phase: Phase 3
• Start date: February 8, 2013
• Est. completion date: November 11, 2016

Study information

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

Clinical Trial Summary

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27564
• Est. completion date: November 11, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female = 40 to = 85 years of age
• History of clinically evident cardiovascular disease at high risk for a recurrent event
• Fasting low-density lipoprotein cholesterol (LDL-C) = 70 mg/dL (= 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) = 100 mg/dL (> 2.6 mmol/L)
• Fasting triglycerides = 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

• New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
• Uncontrolled hypertension
• Uncontrolled or recurrent ventricular tachycardia
• Untreated hyperthyroidism or hypothyroidism
• Homozygous familial hypercholesterolemia
• LDL or plasma apheresis

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Biological:
• Evolocumab
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Drug:
• Placebo
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Locations

Country	Name	City	State
Argentina	Research Site	Bahia Blanca	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Córdoba
Argentina	Research Site	Corrientes
Argentina	Research Site	La Plata	Buenos Aires
Argentina	Research Site	La Plata	Buenos Aires
Argentina	Research Site	Mar del Plata	Buenos Aires
Argentina	Research Site	Mar del Plata	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Argentina	Research Site	Salta
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Ashford	South Australia
Australia	Research Site	Ashford	South Australia
Australia	Research Site	Auchenflower	Queensland
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Epping	Victoria
Australia	Research Site	Footscray	Victoria
Australia	Research Site	Fullarton	South Australia
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Heidelberg	Victoria
Australia	Research Site	Herston	Queensland
Australia	Research Site	Hobart	Tasmania
Australia	Research Site	Kogarah	New South Wales
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	Woden	Australian Capital Territory
Australia	Research Site	Woodville South	South Australia
Australia	Research Site	Woolloongabba	Queensland
Australia	Research Site	Woolloongabba	New South Wales
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	Wels
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Antwerpen
Belgium	Research Site	Blankenberge
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Gent
Belgium	Research Site	Gozee
Belgium	Research Site	Ieper
Belgium	Research Site	La Louviere
Belgium	Research Site	La Louvière
Belgium	Research Site	Liege
Belgium	Research Site	Liège
Belgium	Research Site	Lodelinsart
Belgium	Research Site	Natoye
Belgium	Research Site	Turnhout
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Brasília	Distrito Federal
Brazil	Research Site	Campina Grande do Sul	Paraná
Brazil	Research Site	Campinas	São Paulo
Brazil	Research Site	Campinas	São Paulo
Brazil	Research Site	Canoas	Rio Grande Do Sul
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Fortaleza	Ceará
Brazil	Research Site	Goiania	Goiás
Brazil	Research Site	Passo Fundo	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Rio De Janeiro
Brazil	Research Site	Sao Jose do Rio Preto	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	Vitória	Espírito Santo
Bulgaria	Research Site	Haskovo
Bulgaria	Research Site	Kazanlak
Bulgaria	Research Site	Pazardzhik
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Granby	Quebec
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Lachine	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	New Westminster	British Columbia
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Peterborough	Ontario
Canada	Research Site	Pointe-Claire	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Québec	Quebec
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Sarnia	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	St Jean sur Richelieu	Quebec
Canada	Research Site	St-Charles-Borromee	Quebec
Canada	Research Site	St-Jérôme	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	St. Johns	Newfoundland and Labrador
Canada	Research Site	Strathroy	Ontario
Canada	Research Site	Terrebonne	Quebec
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Westmout	Quebec
Chile	Research Site	Osorno
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Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Temuco	Cautín
Chile	Research Site	Temuco	Cautín
China	Research Site	Baotou	Inner Mongolia
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changchun	Jilin
China	Research Site	Changchun	Jilin
China	Research Site	Changde	Hunan
China	Research Site	Changsha	Hunan
China	Research Site	Changsha	Hunan
China	Research Site	Changsha	Hunan
China	Research Site	Changsha	Hunan
China	Research Site	Dalian	Liaoning
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Harbin	Heilongjiang
China	Research Site	Hohhot	Inner Mongolia
China	Research Site	Linhai	Zhejiang
China	Research Site	Ningbo	Zhejiang
China	Research Site	Qingdao	Shandong
China	Research Site	Shenyang	Liaoning
China	Research Site	Siping	Jilin
China	Research Site	Suzhou	Jiangsu
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tianjin	Tianjin
China	Research Site	Tianjin	Tianjin
China	Research Site	Tianjin
China	Research Site	Urumqi	Xinjiang
China	Research Site	Wenzhou	Zhejiang
China	Research Site	Wuhan	Hubei
China	Research Site	Wuhan	Hubei
China	Research Site	Wuxi	Jiangsu
China	Research Site	Xiangtan	Hunan
China	Research Site	Xuzhou	Jiangsu
China	Research Site	Yinchuan	Ningxia
China	Research Site	Zhengzhou	Henan
China	Research Site	Zhuzhou	Hunan
Colombia	Research Site	Armenia	Quindío
Colombia	Research Site	Barranquilla	Atlántico
Colombia	Research Site	Barranquilla	Atlántico
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Cartagena	Bolívar
Colombia	Research Site	Floridablanca	Santander
Colombia	Research Site	Manizales	Caldas
Colombia	Research Site	Medellin	Antioquia
Colombia	Research Site	Medellin	Antioquia
Colombia	Research Site	Santiago de Cali	Valle Del Cauca
Czechia	Research Site	Benatky nad Jizerou
Czechia	Research Site	Benesov
Czechia	Research Site	Beroun
Czechia	Research Site	Bilovec
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Brno
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Czechia	Research Site	Kutna Hora
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Czechia	Research Site	Praha 4
Czechia	Research Site	Praha 4
Czechia	Research Site	Praha 5
Czechia	Research Site	Praha 5
Czechia	Research Site	Praha 5 - Smichov
Czechia	Research Site	Prerov
Czechia	Research Site	Pribram VIII
Czechia	Research Site	Svitavy
Czechia	Research Site	Teplice
Czechia	Research Site	Uherske Hradiste
Czechia	Research Site	Znojmo
Denmark	Research Site	Aalborg
Denmark	Research Site	Aarhus N
Denmark	Research Site	Ballerup
Denmark	Research Site	Esbjerg
Denmark	Research Site	Glostrup
Denmark	Research Site	Hvidovre
Denmark	Research Site	København
Denmark	Research Site	København S
Denmark	Research Site	Køge
Denmark	Research Site	Odense
Denmark	Research Site	Roskilde
Denmark	Research Site	Svendborg
Denmark	Research Site	Vejle
Denmark	Research Site	Viborg
Estonia	Research Site	Harjumaa
Estonia	Research Site	Paide
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
Finland	Research Site	Hämeenlinna
Finland	Research Site	Helsinki
Finland	Research Site	Helsinki
Finland	Research Site	Jyväskylä
Finland	Research Site	Kokkola
Finland	Research Site	Kuopio
Finland	Research Site	Oulo
Finland	Research Site	Oulu
Finland	Research Site	Tampere
Finland	Research Site	Tampere
Finland	Research Site	Turku
France	Research Site	Besançon Cedex
France	Research Site	Brest Cedex 2
France	Research Site	Chambray les Tours
France	Research Site	Clermont Ferrand
France	Research Site	Créteil
France	Research Site	Dijon cedex
France	Research Site	Le Coudray
France	Research Site	Lille Cedex
France	Research Site	Lyon
France	Research Site	Marseille Cedex 08
France	Research Site	Metz cedex 03
France	Research Site	Montpellier cedex 05
France	Research Site	Montpellier cedex 5
France	Research Site	Nantes Cedex 1
France	Research Site	Nantes Cedex 2
France	Research Site	Nice
France	Research Site	Nimes
France	Research Site	Orleans
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Pau
France	Research Site	Perpignan Cedex
France	Research Site	Pessac Cedex
France	Research Site	Poitiers
France	Research Site	Reims cedex
France	Research Site	Rennes
France	Research Site	Saint Priest en Jarez
France	Research Site	Strasbourg
France	Research Site	Toulouse Cedex 9
France	Research Site	Vandoeuvre les Nancy
France	Research Site	Vesoul
Germany	Research Site	Bad Krozingen
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Demmin
Germany	Research Site	Dortmund
Germany	Research Site	Dresden
Germany	Research Site	Düsseldorf
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Giessen
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Ingelheim
Germany	Research Site	Kassel
Germany	Research Site	Köln
Germany	Research Site	Lahr
Germany	Research Site	Leipzig
Germany	Research Site	Limburg
Germany	Research Site	Magdeburg
Germany	Research Site	Mainz
Germany	Research Site	Mannheim
Germany	Research Site	Marburg
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Regensburg
Germany	Research Site	Stuttgart
Germany	Research Site	Ulm
Germany	Research Site	Witten
Germany	Research Site	Wuppertal
Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Chalkida
Greece	Research Site	Heraklion
Greece	Research Site	Ioannina
Greece	Research Site	Larissa
Greece	Research Site	Nikaia, Piraeus
Greece	Research Site	Piraeus
Greece	Research Site	Rhodes
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	New Territories
Hungary	Research Site	Balatonfured
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Berettyoujfalu
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Cegled
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyongyos
Hungary	Research Site	Gyula
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kecskemet
Hungary	Research Site	Komarom
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Pecs
Hungary	Research Site	Szeged
Hungary	Research Site	Szekszard
Hungary	Research Site	Szolnok
Hungary	Research Site	Zalaegerszeg
Iceland	Research Site	Kopavogur
Iceland	Research Site	Reykjavik
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Belgaum	Karnataka
India	Research Site	Gurgaon	Haryana
India	Research Site	Kolkata	West Bengal
India	Research Site	Lucknow	Uttar Pradesh
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mumbai	Maharashtra
India	Research Site	Mysore	Karnataka
India	Research Site	Nagpur	Maharashtra
India	Research Site	New Delhi	Delhi
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
India	Research Site	Vadodara	Gujarat
India	Research Site	Vijayawada	Andhra Pradesh
Ireland	Research Site	Ballinasloe
Ireland	Research Site	Dublin
Ireland	Research Site	Dublin
Ireland	Research Site	Galway
Israel	Research Site	Hadera
Israel	Research Site	Haifa
Israel	Research Site	Haifa
Israel	Research Site	Herzliya-on-sea
Israel	Research Site	Holon
Israel	Research Site	Jerusalem
Israel	Research Site	Nahariya
Israel	Research Site	Netanya
Israel	Research Site	Rehovot
Israel	Research Site	Tel Aviv
Israel	Research Site	Tel Hashomer
Italy	Research Site	Ascoli Piceno
Italy	Research Site	Bergamo
Italy	Research Site	Bologna
Italy	Research Site	Chieti
Italy	Research Site	Colleferro RM
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Italy	Research Site	Firenze
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Italy	Research Site	Milano
Italy	Research Site	Milano
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Italy	Research Site	Roma
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Japan	Research Site	Asahikawa-shi	Hokkaido
Japan	Research Site	Bunkyo-ku	Tokyo
Japan	Research Site	Chiba-shi	Chiba
Japan	Research Site	Chikushi-gun	Fukuoka
Japan	Research Site	Chikushino-shi	Fukuoka
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Chuo-shi	Yamanashi
Japan	Research Site	Fujisawa-shi	Kanagawa
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Hachioji-shi	Tokyo
Japan	Research Site	Hamada-shi	Shimane
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Japan	Research Site	Ichinomiya-shi	Aichi
Japan	Research Site	Itabashi-ku	Tokyo
Japan	Research Site	Itabashi-ku	Tokyo
Japan	Research Site	Itoshima-shi	Fukuoka
Japan	Research Site	Kanazawa-shi	Ishikawa
Japan	Research Site	Kasugai-shi	Aichi
Japan	Research Site	Kawaguchi-shi	Saitama
Japan	Research Site	Kobe-shi	Hyogo
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Japan	Research Site	Kumamoto-shi	Kumamoto
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Japan	Research Site	Kurume-shi	Fukuoka
Japan	Research Site	Kusatsu-shi	Shiga
Japan	Research Site	Kyoto-shi	Kyoto
Japan	Research Site	Matsudo-shi	Chiba
Japan	Research Site	Musashimurayama-shi	Tokyo
Japan	Research Site	Nagasaki-shi	Nagasaki
Japan	Research Site	Nagoya-shi	Aichi
Japan	Research Site	Nagoya-shi	Aichi
Japan	Research Site	Nagoya-shi	Aichi
Japan	Research Site	Nagoya-shi	Aichi
Japan	Research Site	Niihama-shi	Ehime
Japan	Research Site	Odawara-shi	Kanagawa
Japan	Research Site	Oita-shi	Oita
Japan	Research Site	Okawa-shi	Fukuoka
Japan	Research Site	Okayama-shi	Okayama
Japan	Research Site	Okinawa-shi	Okinawa
Japan	Research Site	Omura-shi	Nagasaki
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Otake-shi	Hiroshima
Japan	Research Site	Saga-shi	Saga
Japan	Research Site	Saga-shi	Saga
Japan	Research Site	Sagamihara-shi	Kanagawa
Japan	Research Site	Saijo-shi	Ehime
Japan	Research Site	Sanuki-shi	Kagawa
Japan	Research Site	Sapporo-shi	Hokkaido
Japan	Research Site	Sendai-shi	Miyagi
Japan	Research Site	Shimajiri-gun	Okinawa
Japan	Research Site	Sunto-gun	Shizuoka
Japan	Research Site	Tachikawa-shi	Tokyo
Japan	Research Site	Toride-shi	Ibaraki
Japan	Research Site	Toyohashi-shi	Aichi
Japan	Research Site	Tsukuba-city	Ibaraki
Japan	Research Site	Urasoe-shi	Okinawa
Japan	Research Site	Yokohama-shi	Kanagawa
Korea, Republic of	Research Site	Busan, Seo-gu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Daejeon
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Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
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Latvia	Research Site	Ogre
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Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Leon	Guanajuato
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Monterrey	Nuevo León
Mexico	Research Site	Queretaro	Querétaro
Mexico	Research Site	San Luis Potosi	San Luis Potosí
Mexico	Research Site	Tampico	Tamaulipas
Mexico	Research Site	Torreon	Coahuila
Mexico	Research Site	Xalapa	Veracruz
Netherlands	Research Site	Alkmaar
Netherlands	Research Site	Almelo
Netherlands	Research Site	Amstelveen
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Beverwijk
Netherlands	Research Site	Den Helder
Netherlands	Research Site	Deventer
Netherlands	Research Site	Doetinchem
Netherlands	Research Site	Ede
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Goes
Netherlands	Research Site	Gorinchem
Netherlands	Research Site	Gouda
Netherlands	Research Site	Harderwijk
Netherlands	Research Site	Helmond
Netherlands	Research Site	Hoogeveen
Netherlands	Research Site	Hoorn
Netherlands	Research Site	Leiden
Netherlands	Research Site	Leiden
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Purmerend
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Sneek
Netherlands	Research Site	Tiel
Netherlands	Research Site	Tilburg
Netherlands	Research Site	Uden
Netherlands	Research Site	Veldhoven
Netherlands	Research Site	Venlo
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Papatoetoe, Auckland
New Zealand	Research Site	Tauranga
Norway	Research Site	Ålesund
Norway	Research Site	Bekkestua
Norway	Research Site	Bodø
Norway	Research Site	Hamar
Norway	Research Site	Lierskogen
Norway	Research Site	Oslo
Norway	Research Site	Skedsmokorset
Norway	Research Site	Skien
Norway	Research Site	Stavanger
Philippines	Research Site	Angeles
Philippines	Research Site	Baguio City
Philippines	Research Site	Dasmariñas Cavite
Philippines	Research Site	Davao City	Davao
Philippines	Research Site	Iloilo
Philippines	Research Site	Makati City
Philippines	Research Site	Manila
Philippines	Research Site	Marikiina
Philippines	Research Site	Quezon City
Philippines	Research Site	Quezon City
Poland	Research Site	Bielsko-Biala
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Gdansk
Poland	Research Site	Gdynia
Poland	Research Site	Gdynia
Poland	Research Site	Gdynia
Poland	Research Site	Gizycko
Poland	Research Site	Jelenia Gora
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Lublin
Poland	Research Site	Lublin
Poland	Research Site	Nowa Sol
Poland	Research Site	Nysa
Poland	Research Site	Olsztyn
Poland	Research Site	Plock
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Pszczyna
Poland	Research Site	Pulawy
Poland	Research Site	Ruda Slaska
Poland	Research Site	Skierniewice
Poland	Research Site	Starogard Gdanski
Poland	Research Site	Staszow
Poland	Research Site	Swidnik
Poland	Research Site	Tarnow
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wloclawek
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Zamosc
Portugal	Research Site	Almada
Portugal	Research Site	Amadora
Portugal	Research Site	Carnaxide
Portugal	Research Site	Coimbra
Portugal	Research Site	Covilha
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Setubal
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Craiova
Romania	Research Site	Iasi
Romania	Research Site	Iasi
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Timisoara
Romania	Research Site	Timisoara
Romania	Research Site	Timisoara
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Pushkin
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Tyumen
Singapore	Research Site	Singapore
Singapore	Research Site	Singapore
Singapore	Research Site	Singapore
Slovakia	Research Site	Banovce nad Bebravou
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Brezno
Slovakia	Research Site	Dolny Kubin
Slovakia	Research Site	Kosice
Slovakia	Research Site	Kosice
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Martin
Slovakia	Research Site	Moldava nad Bodvou
Slovakia	Research Site	Nitra
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Presov
Slovakia	Research Site	Rimavska Sobota
Slovakia	Research Site	Roznava
Slovakia	Research Site	Snina
Slovakia	Research Site	Svidnik
Slovakia	Research Site	Trencin
Slovakia	Research Site	Trnava
South Africa	Research Site	Alberton	Gauteng
South Africa	Research Site	Alberton	Gauteng
South Africa	Research Site	Amanzimtoti	KwaZulu-Natal
South Africa	Research Site	Bloemfontein	Free State
South Africa	Research Site	Boksburg	Gauteng
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town
South Africa	Research Site	Centurion	Gauteng
South Africa	Research Site	Durban	KwaZulu-Natal
South Africa	Research Site	Durban	KwaZulu-Natal
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Johannesburg	Gauteng
South Africa	Research Site	Kempton Park
South Africa	Research Site	Kuils River	Western Cape
South Africa	Research Site	Midrand	Gauteng
South Africa	Research Site	Paarl	Western Cape
South Africa	Research Site	Parow	Western Cape
South Africa	Research Site	Port Elizabeth	Eastern Cape
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Pretoria	Gauteng
South Africa	Research Site	Pretoria west	Gauteng
South Africa	Research Site	Somerset West	Western Cape
South Africa	Research Site	Soweto	Gauteng
South Africa	Research Site	Sunninghill	Gauteng
South Africa	Research Site	Tongaat	KwaZulu-Natal
South Africa	Research Site	Worcester	Western Cape
Spain	Research Site	Almeria	Andalucía
Spain	Research Site	Cordoba	Andalucía
Spain	Research Site	El Palmar	Murcia
Spain	Research Site	Galdakao	País Vasco
Spain	Research Site	L'Hospitalet de Llobregat	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	San Juan de Alicante	Comunidad Valenciana
Spain	Research Site	Santiago de Compostela	Galicia
Spain	Research Site	Valencia	Comunidad Valenciana
Spain	Research Site	Vigo	Galicia
Spain	Research Site	Zaragoza	Aragón
Sweden	Research Site	Bollnäs
Sweden	Research Site	Eksjö
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Falun
Sweden	Research Site	Helsingborg
Sweden	Research Site	Jönköping
Sweden	Research Site	Linköping
Sweden	Research Site	Luleå
Sweden	Research Site	Lund
Sweden	Research Site	Lund
Sweden	Research Site	Örebro
Sweden	Research Site	Östersund
Sweden	Research Site	Stockholm
Sweden	Research Site	Stockholm
Sweden	Research Site	Stockholm
Sweden	Research Site	Stockholm
Sweden	Research Site	Uddevalla
Sweden	Research Site	Umeå
Sweden	Research Site	Västerås
Switzerland	Research Site	Baden
Switzerland	Research Site	Basel
Switzerland	Research Site	Bern
Switzerland	Research Site	Geneva 14
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Lugano
Switzerland	Research Site	Sion
Switzerland	Research Site	Winterthur
Switzerland	Research Site	Zurich
Taiwan	Research Site	Changhua
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	New Taipei City	Taipei
Taiwan	Research Site	Taichung City
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Izmir
Turkey	Research Site	Kocaeli
Turkey	Research Site	Konya
Turkey	Research Site	Sivas
Ukraine	Research Site	Cherkasy
Ukraine	Research Site	Ivano-Frankivsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Uzhgorod
Ukraine	Research Site	Vinnytsia
Ukraine	Research Site	Vinnytsia
Ukraine	Research Site	Zaporizhzhia
Ukraine	Research Site	Zaporizhzhia
Ukraine	Research Site	Zaporizhzhya
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	Addlestone
United Kingdom	Research Site	Arnsley
United Kingdom	Research Site	Basildon
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Bournemouth
United Kingdom	Research Site	Bury St Edmunds
United Kingdom	Research Site	Canterbury
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Chippenham
United Kingdom	Research Site	Chorley
United Kingdom	Research Site	Colchester
United Kingdom	Research Site	Cottingham
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	Haxey, Doncaster
United Kingdom	Research Site	Hayle
United Kingdom	Research Site	Hexham
United Kingdom	Research Site	Hitchin
United Kingdom	Research Site	Inverness
United Kingdom	Research Site	Leamington Spa
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Luton
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Middlesbrough
United Kingdom	Research Site	Newport
United Kingdom	Research Site	Northampton
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Nuneaton
United Kingdom	Research Site	Penzance
United Kingdom	Research Site	Penzance
United Kingdom	Research Site	Penzance
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Portsmouth
United Kingdom	Research Site	Reading
United Kingdom	Research Site	Rotherham
United Kingdom	Research Site	Rugby
United Kingdom	Research Site	Sandbach
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	St Austell
United Kingdom	Research Site	St. Leonards-on-Sea
United Kingdom	Research Site	Stevenage
United Kingdom	Research Site	Stoke-on-Trent
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Telford
United Kingdom	Research Site	Torquay
United Kingdom	Research Site	Welwyn Garden City
United Kingdom	Research Site	West Bromwich
United Kingdom	Research Site	Whitby
United Kingdom	Research Site	Wiltshire
United Kingdom	Research Site	Wirral
United Kingdom	Research Site	Wolverhampton
United Kingdom	Research Site	Worcester
United Kingdom	Research Site	Wrexham
United Kingdom	Research Site	York
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Addison	Illinois
United States	Research Site	Albany	New York
United States	Research Site	Alhambra	California
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Ames	Iowa
United States	Research Site	Anchorage	Alaska
United States	Research Site	Anderson	South Carolina
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Annapolis	Maryland
United States	Research Site	Arlington	Texas
United States	Research Site	Asheville	North Carolina
United States	Research Site	Asheville	North Carolina
United States	Research Site	Athens	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlantis	Florida
United States	Research Site	Auburn	Maine
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Austin	Texas
United States	Research Site	Aventura	Florida
United States	Research Site	Ayer	Massachusetts
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bangor	Maine
United States	Research Site	Banning	California
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Bay Pines	Florida
United States	Research Site	Belleville	Illinois
United States	Research Site	Bend	Oregon
United States	Research Site	Beverly Hills	California
United States	Research Site	Biddeford	Maine
United States	Research Site	Billerica	Massachusetts
United States	Research Site	Billings	Montana
United States	Research Site	Billings	Montana
United States	Research Site	Birmingham	Alabama
United States	Research Site	Birmingham	Alabama
* Note: There are 1287 locations in all - only the first 1000 are shown.

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Iceland,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (6)

Berg DD, Moura FA, Bellavia A, Scirica BM, Wiviott SD, Bhatt DL, Raz I, Bohula EA, Giugliano RP, Park JG, Feinberg MW, Braunwald E, Morrow DA, Sabatine MS. Assessment of Atherothrombotic Risk in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2023 Jun 27;81(25):2391-2402. doi: 10.1016/j.jacc.2023.04.031. — View Citation

Clinical Benefit of Evolocumab Treatment Among Patients With Atherosclerotic Cardiovascular Disease: Exploration Based on the Chinese Subgroup of FOURIER Study, ZHANG Lihua1 , LI Weimin2 , YAO Zhuhua3 , CHEN Jiyan4 , DONG Jun5 , LI Jing1 (Chinese Circulation Journal, 2023, 38: 704.)

Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762. Erratum In: JAMA Cardiol. 2017 Oct 1;2(10):1170. — View Citation

Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647. — View Citation

Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17. — View Citation

Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization	All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".; Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to Cardiovascular Death, Myocardial Infarction, or Stroke	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to Cardiovascular Death	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".; Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.; Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to All Cause Death	Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to First Myocardial Infarction	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".; The diagnosis of myocardial infarction required the combination of: Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and; Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging.; Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to First Stroke	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".; Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.; Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to First Coronary Revascularization	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction".; Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure	All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.; HF hospitalization was defined as an event that met all of the following criteria: Admitted to hospital with a primary diagnosis of HF; In hospital for at least 24 hours; Documented new or worsening symptoms due to HF, including at least 1 of the following: Dyspnea; Decreased exercise tolerance; Fatigue; Other symptoms of worsened end-organ perfusion or volume overload; Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion; Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary	Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack	All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.; Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.; Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.	Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

External Links

•   AmgenTrials clinical trials website