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Primary HypercholesterolemiaVICTORION REALNCT05399992

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 38 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Inclisiran
How many people
847 participants
Where
38 sitesin 8 countries
Study dates
12 Sep 2022to 5 Oct 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

38 sites in 8 countries.

38 sites in 8 countries

United Kingdom11 sites

  • Novartis Investigative Site

    Belfast, BT16 1RH

  • Novartis Investigative Site

    Bromwich, B71 4HJ

  • Novartis Investigative Site

    Burton-on-Trent, DE13 0RB

  • Novartis Investigative Site

    High Wycombe, Buckinghamshire, HP11 2TR

  • Novartis Investigative Site

    Hull, HU3 2RW

  • Novartis Investigative Site

    Lancaster, LA1 4RP

  • Novartis Investigative Site

    Liverpool, L7 8XP

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    Louth, Lincolnshire, LN11 7QU

  • Novartis Investigative Site

    Middlesex, UB9 6JH

  • Novartis Investigative Site

    Sunderland, Tyne and Wear, SR4 7TP

Other trials in United Kingdom

Switzerland8 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Fribourg, CH, 1708

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Lausanne, 1011

  • Novartis Investigative Site

    Olten, 4600

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Zurich, 8032

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Austria6 sites

  • Novartis Investigative Site

    Feldkirch, 6807

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Linz, 4021

  • Novartis Investigative Site

    Sankt Veit im Pongau, 5621

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Vienna, 1180

Other trials in Austria

United Arab Emirates4 sites

  • Novartis Investigative Site

    Abu Dhabi

  • Novartis Investigative Site

    Al Ain City

  • Novartis Investigative Site

    Dubai, United Arab Emirates

  • Novartis Investigative Site

    Dubai

Other trials in United Arab Emirates

Israel3 sites

  • Novartis Investigative Site

    Holon, Gush Dan, 5845997

  • Novartis Investigative Site

    Petah Tikva, 4941492

  • Novartis Investigative Site

    Tel Aviv, 6801296

Other trials in Israel

Saudi Arabia3 sites

  • Novartis Investigative Site

    Jeddah, 23311

  • Novartis Investigative Site

    Riyadh, Saudi, 11643

  • Novartis Investigative Site

    Tabuk, 47512

Other trials in Saudi Arabia

Malaysia2 sites

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50470

  • Novartis Investigative Site

    Kuala Lumpur, 50400

Other trials in Malaysia

China1 site

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518000

Other trials in China

About this study

Official title: 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.

Read the detailed description

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

Being tested
Inclisiran
Keywords
primary hypercholesterolemia, mixed dyslipidemia, real-world study, inclisiran, lipid-lowering therapy, LLT, ASCVD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InclisiranOther

    Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.

Study groups in NCT05399992
Study groupRoleWhat they receive
Inclisiran cohortParticipants prescribed inclisiran alone or with other LLTs as per approved label
Receives: Other: Inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in LDL-C from baseline to 10 months

    Percentage change in Low density lipoprotein - Cholesterol (LDL-C)

    Measured: Baseline, 10 months

Secondary outcomes (18)

  1. Percentage change in LDL-C from baseline

    Percentage change in LDL-C from baseline is collected

    Measured: Baseline, month 4, month 16, month 22

  2. Percentage change in LDL-C from baseline by ≥50%

    Percentage change in LDL-C from baseline by ≥50%

    Measured: Month 4, month 10, month 16, month 22

  3. Percentage change in LDL-C from baseline by ≥30%

    Percentage change in LDL-C from baseline by ≥30%

    Measured: Month 4, month 10, month 16, month 22

  4. Proportion of participants achieving LDL-C<55 mg/dL

    Proportion of participants achieving LDL-C<55 mg/dL

    Measured: Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22

  5. Proportion of participants achieving LDL-C<70 mg/dL

    Proportion of participants achieving LDL-C<70 mg/dL

    Measured: Month 4, month 10, month 16 and month 22

  6. Time-averaged percentage change in LDL-C from baseline

    Time-averaged percentage change in LDL-C from baseline

    Measured: Baseline, month 4, month 10, month 16 and month 22

  7. 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

    Measured: Month 10, month 16, month 22 and month 24

  8. 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

    Measured: Baseline, month 10, month 24

  9. 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

    Measured: Month 10 and month 24

  10. Inclisiran cohort : Percentage of days covered by inclisiran

    Inclisiran cohort : Percentage of days covered by inclisiran

    Measured: 12 months and 24 months

  11. Inclisiran cohort : Mean PDC

    Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected

    Measured: 12 months and 24 months

  12. Inclisiran cohort : Proportion of participants with a PDC ≥ 80%

    Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)

    Measured: 12 months and 24 months

  13. Proportion of participants remaining on initial baseline therapy

    Proportion of patients remaining on initial baseline therapy in the inclisiran cohort

    Measured: Baseline, month 12 and month 24

  14. Time to discontinuation of any newly initiated therapies

    Time to discontinuation of any newly initiated therapies

    Measured: Month 12 and month 24

  15. Time to discontinuation of any newly initiated therapies by specific LLT

    Time to discontinuation of any newly initiated therapies by specific LLT

    Measured: Month 12 and month 24

  16. 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.

    Measured: Baseline, month 12 and month 24

  17. 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).

    Measured: Month 12 and month 24

  18. 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.

    Measured: Month 12 and month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start12 Sep 2022
  3. Primary completion5 Oct 2026 (estimated)
  4. Study completion5 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
847 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05399992
Sponsor's protocol ID
CKJX839A12401
Acronym
VICTORION REAL
Status last verified
Sep 2026
First submitted
27 May 2022
Last updated
24 Sep 2026
Results posted
No

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