Back to resultsGLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Cholesterol, High Cholesterol, Elevated Cholesterol, Raised Cholesterol
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Evolocumab
Arm Description
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in Total Atheroma Volume at Week 78
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Percentage of Participants With Regression in Percent Atheroma Volume
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.
Regression in PAV was defined as any reduction from baseline in PAV.
Percentage of Participants With Regression in Total Atheroma Volume
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Regression in TAV was defined as any reduction from baseline in TAV.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01813422
Brief Title
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
Acronym
GLAGOV
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 18, 2013 (Actual)
Primary Completion Date
July 12, 2016 (Actual)
Study Completion Date
July 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cholesterol, High Cholesterol, Elevated Cholesterol, Raised Cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
970 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha®
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Change From Baseline in Percent Atheroma Volume at Week 78
Description
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.
Time Frame
Baseline and week 78
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Atheroma Volume at Week 78
Description
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Time Frame
Baseline and week 78
Title
Percentage of Participants With Regression in Percent Atheroma Volume
Description
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.
Regression in PAV was defined as any reduction from baseline in PAV.
Time Frame
Baseline and week 78
Title
Percentage of Participants With Regression in Total Atheroma Volume
Description
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Regression in TAV was defined as any reduction from baseline in TAV.
Time Frame
Baseline and week 78
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0960
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Research Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Research Site
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46320
Country
United States
Facility Name
Research Site
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Research Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Research Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Research Site
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
Research Site
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Research Site
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Research Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Research Site
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Research Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Research Site
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Research Site
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Research Site
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Research Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Research Site
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Research Site
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Research Site
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Facility Name
Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1428DCO
Country
Argentina
Facility Name
Research Site
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Research Site
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Research Site
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Research Site
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Research Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Research Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Research Site
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Research Site
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Research Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Research Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Research Site
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Facility Name
Research Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Research Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Research Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Lodelinsart
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Research Site
City
Cariacica
State/Province
Espírito Santo
ZIP/Postal Code
29156-580
Country
Brazil
Facility Name
Research Site
City
Goiania
State/Province
Goiás
ZIP/Postal Code
74223-130
Country
Brazil
Facility Name
Research Site
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80320-320
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Research Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Research Site
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Temuco
State/Province
Cautín
ZIP/Postal Code
4781156
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7650018
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Research Site
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Research Site
City
Zlin
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Research Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Research Site
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Research Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Research Site
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Research Site
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Research Site
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14561
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
17674
Country
Greece
Facility Name
Research Site
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Facility Name
Research Site
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Research Site
City
Galway
Country
Ireland
Facility Name
Research Site
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Research Site
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Rozzano MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Research Site
City
Sesto San Giovanni (MI)
ZIP/Postal Code
20099
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Research Site
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Research Site
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Research Site
City
Penang
ZIP/Postal Code
10050
Country
Malaysia
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Research Site
City
Queretaro
State/Province
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
State/Province
San Luis Potosí
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Research Site
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Research Site
City
Puebla
ZIP/Postal Code
72490
Country
Mexico
Facility Name
Research Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Research Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Research Site
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Research Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Research Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Research Site
City
Tromso
ZIP/Postal Code
9038
Country
Norway
Facility Name
Research Site
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Research Site
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Research Site
City
Kedzierzyn Kozle
ZIP/Postal Code
47-200
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Research Site
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1470
Country
South Africa
Facility Name
Research Site
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Research Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Research Site
City
Kuils River
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
Facility Name
Research Site
City
Pinelands, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Research Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Research Site
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33394
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
L Hospitalet De Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Research Site
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Solna
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Research Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
251
Country
Taiwan
Facility Name
Research Site
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27846344
Citation
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.
Results Reference
background
PubMed Identifier
30336824
Citation
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.
Results Reference
background
PubMed Identifier
33078867
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.
Results Reference
derived
PubMed Identifier
27264224
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
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