GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
GLAGOV
A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
2 other identifiers
interventional
970
32 countries
226
Brief Summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2013
Typical duration for phase_3
226 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedStudy Start
First participant enrolled
April 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2016
CompletedResults Posted
Study results publicly available
January 4, 2018
CompletedFebruary 20, 2019
February 1, 2019
3.2 years
March 15, 2013
December 4, 2017
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Percent Atheroma Volume at Week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Baseline and week 78
Secondary Outcomes (3)
Change From Baseline in Total Atheroma Volume at Week 78
Baseline and week 78
Percentage of Participants With Regression in Percent Atheroma Volume
Baseline and week 78
Percentage of Participants With Regression in Total Atheroma Volume
Baseline and week 78
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Evolocumab
EXPERIMENTALParticipants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Clinical indication for coronary angiography
- 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).
You may not qualify if:
- Coronary artery bypass graft surgery \< 6 weeks prior to the qualifying IVUS
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (226)
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Little Rock, Arkansas, 72211, United States
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La Jolla, California, 92037, United States
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La Jolla, California, 92093-0960, United States
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Long Beach, California, 90822, United States
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Newport Beach, California, 92663, United States
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Orange, California, 92868, United States
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San Diego, California, 92161, United States
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Santa Monica, California, 90404, United States
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Torrance, California, 90502, United States
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Washington D.C., District of Columbia, 20010, United States
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Atlantis, Florida, 33462, United States
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Clearwater, Florida, 33756, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville, Florida, 32216, United States
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Melbourne, Florida, 32901, United States
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Safety Harbor, Florida, 34695, United States
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Atlanta, Georgia, 30342, United States
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Hammond, Indiana, 46320, United States
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Valparaiso, Indiana, 46383, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40205, United States
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Covington, Louisiana, 70433, United States
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Bethesda, Maryland, 20814, United States
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Columbia, Maryland, 21044, United States
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Ann Arbor, Michigan, 48109, United States
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Bay City, Michigan, 48708, United States
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Grand Rapids, Michigan, 49503, United States
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Marquette, Michigan, 49855, United States
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Midland, Michigan, 48670, United States
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Petoskey, Michigan, 49770, United States
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Saginaw, Michigan, 48601, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55407, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Paul, Minnesota, 55102, United States
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Columbia, Missouri, 65212, United States
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Missoula, Montana, 59802, United States
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Omaha, Nebraska, 68198, United States
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Ridgewood, New Jersey, 07450, United States
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Buffalo, New York, 14215, United States
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Johnson City, New York, 13790, United States
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Charlotte, North Carolina, 28204, United States
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Fargo, North Dakota, 58122, United States
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Canton, Ohio, 44710, United States
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Elyria, Ohio, 44035, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74104, United States
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Hillsboro, Oregon, 97123, United States
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Springfield, Oregon, 97477, United States
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Doylestown, Pennsylvania, 18901, United States
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Hershey, Pennsylvania, 17033, United States
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Oak Ridge, Tennessee, 37830, United States
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Amarillo, Texas, 79106, United States
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Dallas, Texas, 75216, United States
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San Antonio, Texas, 78229, United States
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Wichita Falls, Texas, 76301, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1428DCO, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Córdoba, Córdoba Province, X5000JHQ, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Buenos Aires, C1280AEB, Argentina
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Corrientes, W3400AMZ, Argentina
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Córdoba, X5003DCE, Argentina
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Concord, New South Wales, 2139, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Liverpool, New South Wales, 2170, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Chermside, Queensland, 4032, Australia
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Herston, Queensland, 4029, Australia
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Adelaide, South Australia, 5000, Australia
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Bedford Park, South Australia, 5042, Australia
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Epping, Victoria, 3076, Australia
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Footscray, Victoria, 3011, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3004, Australia
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Nedlands, Western Australia, 6009, Australia
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Antwerp, 2020, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Lodelinsart, 6042, Belgium
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Cariacica, Espírito Santo, 29156-580, Brazil
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Goiânia, Goiás, 74223-130, Brazil
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Curitiba, Paraná, 80320-320, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90620-001, Brazil
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São Paulo, São Paulo, 04012-909, Brazil
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São Paulo, 05403-000, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T5H 3V9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Victoria, British Columbia, V8R 4R2, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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London, Ontario, N6A 5A5, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Laval, Quebec, H7M 3L9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1V 4G5, Canada
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Temuco, Cautín, 4781156, Chile
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Santiago, 7650018, Chile
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Santiago, 8207257, Chile
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Santiago, 8330032, Chile
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Prague, 128 08, Czechia
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Prague, 140 21, Czechia
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Ústí nad Labem, 401 13, Czechia
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Zlín, 762 75, Czechia
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Aarhus N, 8200, Denmark
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Odense C, 5000, Denmark
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Besançon, 25030, France
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Chambray-lès-Tours, 37170, France
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Créteil, 94010, France
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Marseille, 13385, France
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Paris, 75015, France
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Pessac, 33604, France
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Aachen, 52074, Germany
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Essen, 45122, Germany
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München, 81737, Germany
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Neuss, 41464, Germany
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Regensburg, 93053, Germany
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Ulm, 89081, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11527, Greece
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Athens, 14561, Greece
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Athens, 17674, Greece
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Heraklion, 71110, Greece
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Budapest, 1023, Hungary
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Budapest, 1106, Hungary
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Budapest, 1122, Hungary
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Budapest, 1134, Hungary
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Debrecen, 4032, Hungary
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Pécs, 7624, Hungary
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Szeged, 6725, Hungary
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Reykjavik, 101, Iceland
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Dublin, 8, Ireland
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Galway, Ireland
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Hadera, 38100, Israel
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Jerusalem, 91031, Israel
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Rehovot, 76100, Israel
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Novara, 28100, Italy
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Roma, 00168, Italy
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Rozzano MI, 20089, Italy
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Sesto San Giovanni (MI), 20099, Italy
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Torino, 10154, Italy
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Kuantan, Pahang, 25100, Malaysia
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George Town, 10050, Malaysia
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Guadalajara, Jalisco, 44670, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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San Luis Potosí City, San Luis Potosí, 78240, Mexico
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Culiacán, Sinaloa, 80020, Mexico
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Aguascalientes, 20230, Mexico
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Puebla City, 72490, Mexico
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Alkmaar, 1815 JD, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Amsterdam, 1091 AC, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Rotterdam, 3079 DZ, Netherlands
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Tilburg, 5042 AD, Netherlands
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Utrecht, 3584 CX, Netherlands
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Venlo, 5912 BL, Netherlands
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Zwolle, 8025 AB, Netherlands
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Oslo, 0424, Norway
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Tromsø, 9038, Norway
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Pasig, 1600, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1102, Philippines
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Chrzanów, 32-500, Poland
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Kędzierzyn-Koźle, 47-200, Poland
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Krakow, 31-202, Poland
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Krakow, 31-501, Poland
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Lodz, 90-549, Poland
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Warsaw, 04-628, Poland
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Kemerovo, 650002, Russia
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Moscow, 101990, Russia
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Moscow, 119991, Russia
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Moscow, 121552, Russia
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Singapore, 169609, Singapore
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Boksburg, Gauteng, 1470, South Africa
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Centurion, Gauteng, 0157, South Africa
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Johannesburg, Gauteng, 2157, South Africa
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Kuils River, Western Cape, 7580, South Africa
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Pinelands, Cape Town, Western Cape, 7405, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Daejeon, 301-723, South Korea
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Seongnam-si, 463-707, South Korea
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Seoul, 130-872, South Korea
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Seoul, 156-707, South Korea
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Málaga, Andalusia, 29010, Spain
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Barcelona, Catalonia, 08035, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Gijón, Principality of Asturias, 33394, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Gothenburg, 413 45, Sweden
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Helsingborg, 251 87, Sweden
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Lund, 221 85, Sweden
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Örebro, 701 85, Sweden
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Solna, 171 76, Sweden
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Stockholm, 118 83, Sweden
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Geneva, 1211, Switzerland
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Sankt Gallen, 9007, Switzerland
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Kaohsiung City, 83301, Taiwan
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New Taipei City, 251, Taiwan
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Taichung, 402, Taiwan
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Taipei, 11217, Taiwan
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Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (4)
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.
PMID: 27846344BACKGROUNDNicholls 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.
PMID: 30336824BACKGROUNDSchmidt 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.
PMID: 33078867DERIVEDPuri 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.
PMID: 27264224DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 19, 2013
Study Start
April 18, 2013
Primary Completion
July 12, 2016
Study Completion
July 29, 2016
Last Updated
February 20, 2019
Results First Posted
January 4, 2018
Record last verified: 2019-02