Semmelweis Lipid Center for High-risk Patients

Prior treatment

• Use of other investigational drugs within 5 half-lives of the first study visit (Screening Visit), within 30 days (e.g., small molecules), or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or if required by local regulations. COVID-19 vaccines granted Emergency Use Authorization are not considered investigational drugs for the purpose of this study.
• current PCSK-9 inhibitor treatment

Other illness

• Ongoing malignancy at the time of the first study visit
• Heart failure (New York Heart Association (NYHA) class IV) at the Screening Visit.

Lab values

• Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit.
• Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter must have AST and ALT ≤3x ULN

Other

• Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

• Male or female ≥ 18 years of age at signing of informed consent
• Subject agrees to the Maximum dose Statin therapy (Rosuvastatin min. 20 mg or Atorvastatin min. 40 mg) Fasting LDL-C local lab value at the Screening Visit ≥ 1.8 mmol/L proved atherosclerotic coronary disease (at least 1 of the below): 1)
• proved atherosclerotic coronary disease (at least 1 of the below): 1) non-obstructive coronary plaques on CT scan in the last 6 months without revascularization, at least in 4 four regions (1-69% stenosis is 2 regions and 25-69% stenosis in 2 other regions); 2)proved acute coronary syndrome in one year with multi-vessel disease (at least 50% stenosis on another artery; post-PCI patient with at least 2 coronary XML File Identifier: ZRG11sdk8OXqmN4mxy3KFqZT0uQ=Page 11/22 arteries involved
• Written informed consent must be obtained before any assessment is performed.