GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
NCT ID: NCT01813422
Last Updated: 2019-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
970 participants
INTERVENTIONAL
2013-04-18
2016-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Placebo
Administered by subcutaneous injection
Evolocumab
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Evolocumab
Administered by subcutaneous injection
Interventions
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Evolocumab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
* Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -\< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
* Evidence of coronary heart disease (at least one lesion in a native coronary artery that has \> 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
* Left main coronary artery \< 50% reduction in lumen diameter by visual estimation
* Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a \> 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).
Exclusion Criteria
* New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
* Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
* Known hemorrhagic stroke
* Uncontrolled hypertension at randomization
* Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
* Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c \[HbA1c\] \> 9%) at screening.
* Moderate to severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) at screening.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Washington D.C., District of Columbia, United States
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Atlantis, Florida, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Safety Harbor, Florida, United States
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Atlanta, Georgia, United States
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Hammond, Indiana, United States
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Valparaiso, Indiana, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Ann Arbor, Michigan, United States
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Bay City, Michigan, United States
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Grand Rapids, Michigan, United States
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Marquette, Michigan, United States
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Midland, Michigan, United States
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Petoskey, Michigan, United States
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Saginaw, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Paul, Minnesota, United States
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Columbia, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Ridgewood, New Jersey, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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Charlotte, North Carolina, United States
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Fargo, North Dakota, United States
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Canton, Ohio, United States
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Elyria, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Hillsboro, Oregon, United States
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Springfield, Oregon, United States
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Doylestown, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Oak Ridge, Tennessee, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Concord, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Liverpool, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Chermside, Queensland, Australia
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Herston, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Epping, Victoria, Australia
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Footscray, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Lodelinsart, , Belgium
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Cariacica, Espírito Santo, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Temuco, Cautín, Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Zlín, , Czechia
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Aarhus N, , Denmark
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Odense C, , Denmark
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Besançon, , France
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Chambray-lès-Tours, , France
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Créteil, , France
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Marseille, , France
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Paris, , France
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Pessac, , France
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Aachen, , Germany
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Essen, , Germany
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München, , Germany
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Neuss, , Germany
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Regensburg, , Germany
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Ulm, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Reykjavik, , Iceland
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Dublin, , Ireland
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Galway, , Ireland
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Hadera, , Israel
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Jerusalem, , Israel
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Rehovot, , Israel
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Novara, , Italy
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Roma, , Italy
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Rozzano MI, , Italy
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Sesto San Giovanni (MI), , Italy
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Torino, , Italy
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Kuantan, Pahang, Malaysia
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George Town, , Malaysia
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Guadalajara, Jalisco, Mexico
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Querétaro City, Querétaro, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Culiacán, Sinaloa, Mexico
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Aguascalientes, , Mexico
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Puebla City, , Mexico
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Alkmaar, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Leeuwarden, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Utrecht, , Netherlands
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Venlo, , Netherlands
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Zwolle, , Netherlands
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Oslo, , Norway
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Tromsø, , Norway
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Pasig, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Chrzanów, , Poland
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Kędzierzyn-Koźle, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Singapore, , Singapore
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Boksburg, Gauteng, South Africa
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Centurion, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Kuils River, Western Cape, South Africa
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Pinelands, Cape Town, Western Cape, South Africa
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Somerset West, Western Cape, South Africa
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Daejeon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Málaga, Andalusia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Gijón, Principality of Asturias, Spain
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Madrid, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Helsingborg, , Sweden
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Lund, , Sweden
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Örebro, , Sweden
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Solna, , Sweden
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Stockholm, , Sweden
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Geneva, , Switzerland
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Sankt Gallen, , Switzerland
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Newcastle upon Tyne, , United Kingdom
Countries
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References
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Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.
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.
Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-004208-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120153
Identifier Type: -
Identifier Source: org_study_id
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