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

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ClinicalTrials.gov Identifier: NCT01813422
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : January 4, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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 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

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab
U.S. FDA Resources

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®



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.




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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813422


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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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    Key Record Dates
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