Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

At least 2 coronary vessels suitable for CCTA; vessels fulfilling all requirements below: a. patent main branch b. no previous stent placement
At least two of the evaluable vessels with subclinical coronary artery disease as defined non-invasively by CCTA with encroachment of the vessel and either: a. Lesion with visual diameter stenosis (DS) < 50% or, b. Lesion with visual DS ≥ 50% and FFRCT > 0.80;
No planned coronary revascularization (during the course of the study) at the time of enrollment;
Most recent, taken within 30 days prior to informed consent form (ICF) signature, fasting LDL-C ≥ 80 mg/dL (≥ 2.07 mmol/L) and on stable statin therapy for at least 30 days at the time of blood sampling, or statin-intolerant or for whom a statin is contraindicated.
Subject signed informed consent form

Exclusion Criteria:

History of coronary artery bypass surgery, heart transplantation, surgical or percutaneous valve repair and/or replacement
New York Heart Association (NYHA) class III or IV heart failure
Last known left ventricular ejection fraction <30%
Active liver disease or hepatic dysfunction, either known or defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN)
Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
Active malignancy except for adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm (e.g. successfully treated cervical cancer in situ or non-active prostate cancer) Imaging CCTA-related
Absence of baseline CCTA obtained in the context of standard clinical care
Baseline CCTA not meeting Core Lab quality standards

Any contraindication for repeat CCTA such as known anaphylactic allergy to iodinated contrast

Concomitant and study medication

Any prior or current use of PCSK9 inhibition treatment or any other experimental lipid-related drug Other exclusion criteria
LDL or plasma apheresis within 12 months of screening
Subject < 18 years of age
Legally incompetent to provide written informed consent;
Known pregnancy or breast-feeding at time of screening
Female subject of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause)
Male subject with female partner of childbearing potential who is not using highly effective birth control
Currently participating in another trial