Clinical trial NCT02207634: Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
Official title: A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Keywords: High cholesterol
Treatment for high cholesterol
Lowering cholesterol
Lowering high cholesterol
Hypercholesterolemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 1974
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

Detailed description: Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in select countries (selected based on study start-up timelines) were invited to participate in this cognitive function study, 20130385. There was no separate randomization for Study 20130385; data were analyzed according to Study 20110118 randomized treatment arm.

Eligibility criteria: Inclusion Criteria:

* Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion Criteria:

* Current or known past diagnosis of dementia or mild cognitive impairment (MCI)

Primary outcomes:
measure: Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score
timeFrame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Secondary outcomes:
measure: Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score
timeFrame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
measure: Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score
timeFrame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
measure: Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score
timeFrame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Alhambra
country: United States
facility: Research Site
state: California
city: Banning
country: United States
facility: Research Site
state: California
city: Harbor City
country: United States
facility: Research Site
state: California
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Oxnard
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Roseville
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Pedro
country: United States
facility: Research Site
state: California
city: Tarzana
country: United States
facility: Research Site
state: California
city: Thousand Oaks
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
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state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Crystal River
country: United States
facility: Research Site
state: Florida
city: Daytona Beach
country: United States
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state: Florida
city: Deerfield Beach
country: United States
facility: Research Site
state: Florida
city: Fleming Island
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Palm Harbor
country: United States
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state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Ponte Vedra
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
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state: Florida
city: West Palm Beach
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Augusta
country: United States
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state: Georgia
city: Gainesville
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Suwanee
country: United States
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state: Georgia
city: Coeur d'Alene
country: United States
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state: Idaho
city: Addison
country: United States
facility: Research Site
state: Illinois
city: Belleville
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Jerseyville
country: United States
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state: Illinois
city: Hammond
country: United States
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state: Indiana
city: Waterloo
country: United States
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city: Hutchinson
country: United States
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city: Lexington
country: United States
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state: Kentucky
city: Owensboro
country: United States
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state: Kentucky
city: Baton Rouge
country: United States
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city: Hammond
country: United States
facility: Research Site
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city: Lafayette
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city: Metairie
country: United States
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city: Monroe
country: United States
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state: Louisiana
city: Slidell
country: United States
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state: Louisiana
city: Biddeford
country: United States
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state: Maine
city: Salisbury
country: United States
facility: Research Site
state: Maryland
city: Towson
country: United States
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state: Maryland
city: Haverhill
country: United States
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state: Massachusetts
city: Newton
country: United States
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city: Ann Arbor
country: United States
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state: Michigan
city: Grandville
country: United States
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city: Lansing
country: United States
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city: Muskegon
country: United States
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state: Michigan
city: Saint Paul
country: United States
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city: Jefferson City
country: United States
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city: Saint Louis
country: United States
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city: Saint Louis
country: United States
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state: Missouri
city: Great Falls
country: United States
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state: Montana
city: Kalispell
country: United States
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state: Montana
city: Voorhees
country: United States
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state: New Jersey
city: Westwood
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
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state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Cortlandt Manor
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: New Windsor
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
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state: New York
city: Troy
country: United States
facility: Research Site
state: New York
city: West Seneca
country: United States
facility: Research Site
state: New York
city: Williamsville
country: United States
facility: Research Site
state: New York
city: Calabash
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
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state: North Carolina
city: Mooresville
country: United States
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state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Tabor City
country: United States
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state: North Carolina
city: Winston-Salem
country: United States
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city: Grand Forks
country: United States
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state: North Dakota
city: Canton
country: United States
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city: Cincinnati
country: United States
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city: Columbus
country: United States
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city: Columbus
country: United States
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city: Dayton
country: United States
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city: Toledo
country: United States
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city: Pryor
country: United States
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state: Oklahoma
city: Bend
country: United States
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city: Portland
country: United States
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state: Oregon
city: Portland
country: United States
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state: Oregon
city: Camp Hill
country: United States
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state: Pennsylvania
city: Chambersburg
country: United States
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state: Pennsylvania
city: Feasterville
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Pawtucket
country: United States
facility: Research Site
state: Rhode Island
city: Fort Mill
country: United States
facility: Research Site
state: South Carolina
city: Moncks Corner
country: United States
facility: Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: North Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Jackson
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Tullahoma
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: Wichita Falls
country: United States
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state: Texas
city: West Jordan
country: United States
facility: Research Site
state: Utah
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Falls Church
country: United States
facility: Research Site
state: Virginia
city: Hopewell
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Suffolk
country: United States
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state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Woden
country: Australia
facility: Research Site
state: Australian Capital Territory
city: Auchenflower
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Ashford
country: Australia
facility: Research Site
state: South Australia
city: Fullarton
country: Australia
facility: Research Site
state: South Australia
city: Hobart
country: Australia
facility: Research Site
state: Tasmania
city: Box Hill
country: Australia
facility: Research Site
state: Victoria
city: Epping
country: Australia
facility: Research Site
state: Victoria
city: Geelong
country: Australia
facility: Research Site
state: Victoria
city: Aalst
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gozee
country: Belgium
facility: Research Site
city: Ieper
country: Belgium
facility: Research Site
city: La Louvière
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: St. Johns
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Sarnia
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: St Jean sur Richelieu
country: Canada
facility: Research Site
state: Quebec
city: St-Jérôme
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Beroun
country: Czechia
facility: Research Site
city: Bilovec
country: Czechia
facility: Research Site
city: Brandys nad Labem
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Chomutov
country: Czechia
facility: Research Site
city: Havlickuv Brod
country: Czechia
facility: Research Site
city: Hodonin
country: Czechia
facility: Research Site
city: Klatovy IV
country: Czechia
facility: Research Site
city: Liberec
country: Czechia
facility: Research Site
city: Litomysl
country: Czechia
facility: Research Site
city: Mohelnice
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Ostrava - Vitkovice
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 3
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 5 - Smichov
country: Czechia
facility: Research Site
city: Prerov
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: København S
country: Denmark
facility: Research Site
city: Køge
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Paide
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Jyväskylä
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: OYS
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Besançon Cedex
country: France
facility: Research Site
city: Le Coudray
country: France
facility: Research Site
city: Montepellier Cedex
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Bad Krozingen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Wuppertal
country: Germany
facility: Research Site
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Berettyoujfalu
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szekszard
country: Hungary
facility: Research Site
city: Szikszo
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Ichinomiya-shi
country: Japan
facility: Research Site
state: Aichi
city: Kasugai-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Toyohashi-shi
country: Japan
facility: Research Site
state: Aichi
city: Matsudo-shi
country: Japan
facility: Research Site
state: Chiba
city: Saijo-shi
country: Japan
facility: Research Site
state: Ehime
city: Chikushi-gun
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Itoshima-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Research Site
state: Hyogo
city: Toride-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Tsukuba-city
country: Japan
facility: Research Site
state: Ibaraki
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Okinawa-shi
country: Japan
facility: Research Site
state: Okinawa
city: Shimajiri-gun
country: Japan
facility: Research Site
state: Okinawa
city: Urasoe-shi
country: Japan
facility: Research Site
state: Okinawa
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Saga-shi
country: Japan
facility: Research Site
state: Saga
city: Saga-shi
country: Japan
facility: Research Site
state: Saga
city: Kawaguchi-shi
country: Japan
facility: Research Site
state: Saitama
city: Komatsushima-shi
country: Japan
facility: Research Site
state: Tokushima
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Daugavpils
country: Latvia
facility: Research Site
city: Kuldiga
country: Latvia
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city: Liepaja
country: Latvia
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country: Latvia
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country: Latvia
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country: Latvia
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country: Latvia
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country: Lithuania
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country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Arnhem
country: Netherlands
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city: Ede
country: Netherlands
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city: Eindhoven
country: Netherlands
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country: Netherlands
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city: Uden
country: Netherlands
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country: New Zealand
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country: New Zealand
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city: Hamar
country: Norway
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city: Lierskogen
country: Norway
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city: Oslo
country: Norway
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city: Skedsmokorset
country: Norway
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country: Norway
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country: Norway
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city: Ålesund
country: Norway
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country: Poland
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country: Poland
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country: Poland
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city: Katowice
country: Poland
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city: Katowice
country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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city: Ruda Slaska
country: Poland
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city: Staszow
country: Poland
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country: Poland
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city: Tarnow
country: Poland
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city: Torun
country: Poland
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country: Poland
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city: Warszawa
country: Poland
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city: Warszawa
country: Poland
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city: Wloclawek
country: Poland
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city: Wroclaw
country: Poland
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city: Wroclaw
country: Poland
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country: Poland
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country: Poland
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country: Portugal
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country: Portugal
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city: Coimbra
country: Portugal
facility: Research Site
city: Covilha
country: Portugal
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city: Ekaterinburg
country: Russian Federation
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city: Ivanovo
country: Russian Federation
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city: Izhevsk
country: Russian Federation
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city: Kemerovo
country: Russian Federation
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city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Pushkin
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Moldava nad Bodvou
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Roznava
country: Slovakia
facility: Research Site
city: Snina
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Centurion
country: South Africa
facility: Research Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Research Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Research Site
state: Gauteng
city: Pretoria west
country: South Africa
facility: Research Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Paarl
country: South Africa
facility: Research Site
state: Western Cape
city: Parow
country: South Africa
facility: Research Site
state: Western Cape
city: Somerset West
country: South Africa
facility: Research Site
state: Western Cape
city: Worcester
country: South Africa
facility: Research Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Research Site
city: Kempton Park
country: South Africa
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Cataluña
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Vigo
country: Spain
facility: Research Site
state: Galicia
city: Galdakao
country: Spain
facility: Research Site
state: País Vasco
city: Madrid
country: Spain
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hexham
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newport
country: United Kingdom
facility: Research Site
city: Nuneaton
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Sandbach
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: West Bromwich
country: United Kingdom
facility: Research Site
city: Whitby
country: United Kingdom
facility: Research Site
city: Worcester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16.
citation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.
citation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.