Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD (VICTORION REAL)

VICTORION REAL: An International Prospective Real-world Study to Evaluate the LDL-C changE and Adherence to incLisiran in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia

This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.

Study Overview

• Status: Active, not recruiting
• Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia
• Intervention / Treatment: Other: Inclisiran

Detailed Description

Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.

• Study Type: Observational
• Enrollment (Actual): 847

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6807
    • Novartis Investigative Site
  • Graz, Austria, 8036
    • Novartis Investigative Site
  • Linz, Austria, 4021
    • Novartis Investigative Site
  • Sankt Veit im Pongau, Austria, 5621
    • Novartis Investigative Site
  • Vienna, Austria, 1090
    • Novartis Investigative Site
  • Vienna, Austria, 1180
    • Novartis Investigative Site
• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Novartis Investigative Site
• Israel
  • Petah Tikva, Israel, 4941492
    • Novartis Investigative Site
  • Tel Aviv, Israel, 6801296
    • Novartis Investigative Site
  • Gush Dan
    • Holon, Gush Dan, Israel, 5845997
      • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Novartis Investigative Site
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50470
      • Novartis Investigative Site
• Saudi Arabia
  • Jeddah, Saudi Arabia, 23311
    • Novartis Investigative Site
  • Tabuk, Saudi Arabia, 47512
    • Novartis Investigative Site
  • Saudi
    • Riyadh, Saudi, Saudi Arabia, 11643
      • Novartis Investigative Site
• Switzerland
  • Basel, Switzerland, 4031
    • Novartis Investigative Site
  • Geneva, Switzerland, 1211
    • Novartis Investigative Site
  • Lausanne, Switzerland, 1011
    • Novartis Investigative Site
  • Olten, Switzerland, 4600
    • Novartis Investigative Site
  • Sankt Gallen, Switzerland, 9007
    • Novartis Investigative Site
  • Zurich, Switzerland, 8091
    • Novartis Investigative Site
  • Zurich, Switzerland, 8032
    • Novartis Investigative Site
  • CH
    • Fribourg, CH, Switzerland, 1708
      • Novartis Investigative Site
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Novartis Investigative Site
  • Al Ain City, United Arab Emirates
    • Novartis Investigative Site
  • Dubai, United Arab Emirates
    • Novartis Investigative Site
  • Abu Dhabi Emirate
    • Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 00000
      • Novartis Investigative Site
  • United Arab Emirates
    • Dubai, United Arab Emirates, United Arab Emirates, 7272
      • Novartis Investigative Site
• United Kingdom
  • Belfast, United Kingdom, BT16 1RH
    • Novartis Investigative Site
  • Bromwich, United Kingdom, B71 4HJ
    • Novartis Investigative Site
  • Burton-on-Trent, United Kingdom, DE13 0RB
    • Novartis Investigative Site
  • Cardiff, United Kingdom, CF14 4XW
    • Novartis Investigative Site
  • Hull, United Kingdom, HU3 2RW
    • Novartis Investigative Site
  • Lancaster, United Kingdom, LA1 4RP
    • Novartis Investigative Site
  • Liverpool, United Kingdom, L7 8XP
    • Novartis Investigative Site
  • London, United Kingdom, NW3 2QG
    • Novartis Investigative Site
  • Middlesex, United Kingdom, UB9 6JH
    • Novartis Investigative Site
  • Buckinghamshire
    • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TR
      • Novartis Investigative Site
  • Lincolnshire
    • Louth, Lincolnshire, United Kingdom, LN11 7QU
      • Novartis Investigative Site
  • Tyne and Wear
    • Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult participants with an underlying diagnosis of Atherosclerotic Cardiovascular Disease (ASCVD), ASCVD risk equivalent (ASCVD RE), or Heterozygous familial hypercholesterolemia (HeFH) and elevated levels of Low density lipoprotein - Cholesterol (LDL-C)

Description

Inclusion Criteria:

1. Participants who are 18 years or older
2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
4. Participants who per physician's criteria need to optimize their LLT
5. Participants who provide written informed consent to participate in the study
6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.

Exclusion Criteria:

1. Participants that have received inclisiran previously
2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inclisiran cohort; Participants prescribed inclisiran alone or with other LLTs as per approved label	Other: Inclisiran; Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.

What is the study measuring?

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 16, month 22
Percentage change in LDL-C from baseline by ≥50%	Percentage change in LDL-C from baseline by ≥50%	Month 4, month 10, month 16, month 22
Percentage change in LDL-C from baseline by ≥30%	Percentage change in LDL-C from baseline by ≥30%	Month 4, month 10, month 16, month 22
Inclisiran cohort : Mean PDC	Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected	12 months and 24 months
Proportion of participants remaining on initial baseline therapy	Proportion of patients remaining on initial baseline therapy in the inclisiran cohort	Baseline, month 12 and month 24
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 and month 24
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 and month 24
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 for inclisiran participants.	Month 12 and month 24
Proportion of participants achieving LDL-C<55 mg/dL	Proportion of participants achieving LDL-C<55 mg/dL	Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22
Proportion of participants achieving LDL-C<70 mg/dL	Proportion of participants achieving LDL-C<70 mg/dL	Month 4, month 10, month 16 and month 22
Time-averaged percentage change in LDL-C from baseline	Time-averaged percentage change in LDL-C from baseline	Baseline, month 4, month 10, month 16 and month 22
Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months	Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months	Month 10, month 16, month 22 and month 24
Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months	Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months	Baseline, month 10, month 24
Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months	Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months	Month 10 and month 24
Inclisiran cohort : Percentage of days covered by inclisiran	Inclisiran cohort : Percentage of days covered by inclisiran	12 months and 24 months
Inclisiran cohort : Proportion of participants with a PDC ≥ 80%	Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)	12 months and 24 months
Time to discontinuation of any newly initiated therapies	Time to discontinuation of any newly initiated therapies	Month 12 and month 24
Time to discontinuation of any newly initiated therapies by specific LLT	Time to discontinuation of any newly initiated therapies by specific LLT	Month 12 and month 24

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ASCVD; real-world study; inclisiran; lipid-lowering therapy; mixed dyslipidemia; primary hypercholesterolemia; LLT
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Dyslipidemias; ALN-PCS
• Other Study ID Numbers: CKJX839A12401