GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 970.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Cholesterol; High Cholesterol; Elevated Cholesterol; Raised Cholesterol

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.
    

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.