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

January 30, 2026 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
847

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change in LDL-C from baseline to 10 months
Time Frame: Baseline, 10 months
Percentage change in Low density lipoprotein - Cholesterol (LDL-C)
Baseline, 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage change in LDL-C from baseline
Time Frame: Baseline, month 4, month 16, month 22
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%
Time Frame: Month 4, month 10, month 16, month 22
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%
Time Frame: Month 4, month 10, month 16, month 22
Percentage change in LDL-C from baseline by ≥30%
Month 4, month 10, month 16, month 22
Inclisiran cohort : Mean PDC
Time Frame: 12 months and 24 months
Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected
12 months and 24 months
Proportion of participants remaining on initial baseline therapy
Time Frame: Baseline, month 12 and month 24
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
Time Frame: Baseline, month 12 and month 24

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
Time Frame: Month 12 and month 24

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
Time Frame: Month 12 and month 24

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
Time Frame: Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22
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
Time Frame: Month 4, month 10, month 16 and month 22
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 Frame: Baseline, month 4, month 10, month 16 and month 22
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
Time Frame: Month 10, month 16, month 22 and month 24
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
Time Frame: Baseline, month 10, month 24
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
Time Frame: Month 10 and month 24
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
Time Frame: 12 months and 24 months
Inclisiran cohort : Percentage of days covered by inclisiran
12 months and 24 months
Inclisiran cohort : Proportion of participants with a PDC ≥ 80%
Time Frame: 12 months and 24 months
Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)
12 months and 24 months
Time to discontinuation of any newly initiated therapies
Time Frame: Month 12 and month 24
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 Frame: Month 12 and month 24
Time to discontinuation of any newly initiated therapies by specific LLT
Month 12 and month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CKJX839A12401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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