GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Biological: Evolocumab; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	970 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Actual Study Start Date :	April 18, 2013
Actual Primary Completion Date :	July 12, 2016
Actual Study Completion Date :	July 29, 2016

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.	Drug: Placebo; Administered by subcutaneous injection
Experimental: Evolocumab; Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.	Biological: Evolocumab; Administered by subcutaneous injection; Other Names: AMG 145; Repatha®

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Percent Atheroma Volume at Week 78 [ Time Frame: Baseline and 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 :

1. Change From Baseline in Total Atheroma Volume at Week 78 [ Time Frame: Baseline and 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.
2. Percentage of Participants With Regression in Percent Atheroma Volume [ Time Frame: Baseline and 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.

   Regression in PAV was defined as any reduction from baseline in PAV.

3. Percentage of Participants With Regression in Total Atheroma Volume [ Time Frame: Baseline and 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.

   Regression in TAV was defined as any reduction from baseline in TAV.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Additional Information:

AmgenTrials clinical trials website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01813422 History of Changes
Other Study ID Numbers:	20120153; 2012-004208-37 ( EudraCT Number )
First Posted:	March 19, 2013
Results First Posted:	January 4, 2018
Last Update Posted:	February 5, 2018
Last Verified:	January 2018

Keywords provided by Amgen:

Cholesterol; High Cholesterol; Elevated Cholesterol; Raised Cholesterol

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders	Metabolic Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs