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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 99
Updated:2/22/2019
Start Date:April 18, 2013
End Date:July 29, 2016

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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

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.


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.
We found this trial at
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