VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease

Eligibility Criteria

• 1. Males and females \>= 18 years of age
• 2. Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
• 3. Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
• 4. Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
• 5. On statin therapy, or have documented statin intolerance, as determined by the treating clinician.
• 6. From historically underrepresented populations in cardiovascular clinical research, including at least one of the following: female sex; Hispanic/Latino ethnicity; Black/African-American, Asian, or Native American race; rural dwelling based on the HRSA definition for determining rural grant eligibility.
• 1. Planned use of other investigational products or devices during the course of the study.
• 2. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
• 3. History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
• 4. Pregnant or nursing (lactating) women.
• 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
• 6. New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<25%.
• 7. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or other methods (i.e. via ablation etc.) at the time of pre-screening.
• 8. Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
• 9. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase (ALT) elevation \>3x ULN, aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \>2x ULN (except participants with Gilbert's syndrome) at pre-screening confirmed by a repeat measurement at least one week apart.
• 10. End-stage renal disease (ESRD)