Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD

Study Overview
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Brief Summary
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This observational matched prospective study aims to assess the effectiveness and adherence for inclisiran in combination with Lipid lowering therapies or Lipid lowering treatments (LLT) compared to other LLTs under conditions of routine clinical practice.

Detailed Description
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Patients will be enrolled over a period of 24 months, and followed for up to 36 months to assess for study outcomes.

Official Title
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VICTORION REAL: An International Prospective Real-world Study to Evaluate the Effectiveness and Adherence of Inclisiran Plus Standard of Care Lipid-lowering Therapy Compared to Standard of Care Therapy Alone in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Conditions
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Mixed Dyslipidemia, Primary Hypercholesterolemia

Intervention / Treatment
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* Other: Inclisiran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 18 years or older Patients with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH Patients who are not at LDL-C goal as per their CV risk according to respective clinical guidelines Patients who per physician's criteria need to optimize their LLT Patients who provide written informed consent to participate in the study Cohort-specific: Inclisiran Cohort - Patients who initiate inclisiran under conditions per local label SoC Cohort - Patients who initiate a LLT therapy other than inclisiran, or patients who have existing LLT switched or modified (dosage) no more than 4 months after the Index Date for their matched Inclisiran Cohort patient, and anytime during the 24 month enrollment period. Eligible LLT's include statins, ezetimibe, PCSK9 inhibitors (alirocumab, evolocumab), fibrates, bempedoic acid or bile acid sequestrants. Exclusion Criteria: Patients that have received inclisiran previously Patients participating in a clinical trial with investigational product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inclisiran cohort<br>Participants prescribed inclisiran in combination with Standard of Care (SoC) | Other: Inclisiran<br>* Prospective observational study. There is no treatment allocation. Patients who are receiving or intend to receive inclisiran are eligible to enroll into this study.<br>|
| SoC cohort<br>Participants prescribed standard of Care (SoC) only. Patients can be treated with maximum tolerated dose of statins and/or with add-on therapy with ezetimibe, PCSK9 inhibitors (alirocumab or evolocumab), fibrates, bempedoic acid or bile acid sequestrants, but not inclisiran. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in LDL-C from baseline to 10 months | Percentage change in Low density lipoprotein - Cholesterol (LDL-C) | Baseline, 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in LDL-C from baseline | Percentage change in LDL-C from baseline is collected | Baseline, month 4, month 22, month 34 | 
| Percentage of patients achieving LDL-C<55 mg/dL | Percentage of patients achieving LDL-C<55 mg/dL is collected | Month 4, month 10, month 22, month 34 | 
| Percentage of patients achieving LDL-C <70 mg/dL | Percentage of patients achieving LDL-C <70 mg/dL is collected | Month 4, month 10, month 22, month 34 | 
| Inclisiran cohort only: Mean PDC | Mean Proportion of Days Covered (PDC) for inclisiran cohort only is collected | 12 months, 24 months and 36 months | 
| Percentage of patients remaining on initial baseline therapy | Percentage of patients remaining on initial baseline therapy in the inclisiran cohort compared to SoC Cohort | Baseline, month 12, month 24, month 36 | 
| Change from baseline in scores from the TSQM (modified) instrument | The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication. | Baseline, month 12, month 24, month 36 | 
| Descriptive adherence data based on Adherence AAQ | Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy. AAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent). | Month 12, month 24, month 36 | 
| Descriptive adherence data based on ABQ | Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence. ABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported separately for reach treatment group. | Month 12, month 24, month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LLT, ASCVD, mixed dyslipidemia, real-world study, inclisiran, lipid-lowering therapy, primary hypercholesterolemia