VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease (NCT06249165) | Clinical Trial Compass
Active — Not RecruitingPhase 4
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
United States130 participantsStarted 2024-12-16
Plain-language summary
VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females \>= 18 years of age
✓. Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
✓. 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.
✓. Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
✓. On statin therapy, or have documented statin intolerance, as determined by the treating clinician. Participants for whom statin therapy has been recently initiated must be on stable therapy for at least 4 weeks and subsequent LDL-C must be above the threshold.
✓. 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 using the Federal Office of Rural Health Policy (FORHP) 2010 County and Census Tract file.
Exclusion criteria
✕. Planned use of other investigational products or devices during the course of the study.
✕. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
✕. History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
✕. 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.
✕. New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<25%.
✕. 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. Controlled arrhythmia is not an exclusion.
✕. Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.