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

February 29, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

2100

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 Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • Recruiting
        • Novartis Investigative Site
      • Graz, Austria, A-8036
        • Recruiting
        • Novartis Investigative Site
      • Linz, Austria, 4021
        • Recruiting
        • Novartis Investigative Site
      • St. Veit, Austria, 5621
        • Recruiting
        • Novartis Investigative Site
      • Wels, Austria, A-4600
        • Recruiting
        • Novartis Investigative Site
      • Wien, Austria, A-1090
        • Recruiting
        • Novartis Investigative Site
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, A 4020
        • Recruiting
        • Novartis Investigative Site
  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Novartis Investigative Site
      • Shenzhen, Guangdong, China, 518000
        • Withdrawn
        • Novartis Investigative Site
  • Israel
      • Petach Tikva, Israel, 4941492
        • Recruiting
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6801296
        • Recruiting
        • Novartis Investigative Site
    • Gush Dan
      • Holon, Gush Dan, Israel, 5845997
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Recruiting
        • Novartis Investigative Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50470
        • Recruiting
        • Novartis Investigative Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21499
        • Recruiting
        • Novartis Investigative Site
      • Jeddah, Saudi Arabia, 21159
        • Recruiting
        • Novartis Investigative Site
      • Tabuk, Saudi Arabia, 47512
        • Recruiting
        • Novartis Investigative Site
    • Saudi
      • Riyadh, Saudi, Saudi Arabia, 11643
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Novartis Investigative Site
      • Geneve 14, Switzerland, 1211
        • Recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Novartis Investigative Site
      • Olten, Switzerland, 4600
        • Recruiting
        • Novartis Investigative Site
      • St Gallen, Switzerland, 9007
        • Recruiting
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8091
        • Recruiting
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8032
        • Recruiting
        • Novartis Investigative Site
    • CH
      • Fribourg, CH, Switzerland, 1708
        • Recruiting
        • Novartis Investigative Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Abu Dhabi, United Arab Emirates, 112412
        • Recruiting
        • Novartis Investigative Site
      • Al Ain, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Dubai, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
      • Dubai, United Arab Emirates, 7272
        • Recruiting
        • Novartis Investigative Site
    • Sharjah
      • Kalba, Sharjah, United Arab Emirates
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Belfast, United Kingdom, BT16 1RH
        • Recruiting
        • Novartis Investigative Site
      • Bromwich, United Kingdom, B71 4HJ
        • Recruiting
        • Novartis Investigative Site
      • Burton on Trent, United Kingdom, DE13 0RB
        • Recruiting
        • Novartis Investigative Site
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Novartis Investigative Site
      • Hull, United Kingdom, HU3 2JZ
        • Recruiting
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Novartis Investigative Site
      • Middlesex, United Kingdom, UB9 6JH
        • Recruiting
        • Novartis Investigative Site
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TR
        • Recruiting
        • Novartis Investigative Site
    • Lancashire
      • Lancaster, Lancashire, United Kingdom, LA1 4RP
        • Recruiting
        • Novartis Investigative Site
    • Tyne And Wear
      • Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
        • Recruiting
        • 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

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 patients 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. Patients who are 18 years or older
  2. Patients with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
  3. Patients who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
  4. Patients who per physician's criteria need to optimize their LLT
  5. Patients who provide written informed consent to participate in the study

  6. Cohort-specific:

    1. Inclisiran Cohort

      - Patients who initiate inclisiran under conditions per local label

    2. 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:

  1. Patients that have received inclisiran previously
  2. Patients participating in a clinical trial with investigational product

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
Intervention / Treatment
Inclisiran cohort
Participants prescribed inclisiran in combination with Standard of Care (SoC)
Other: Inclisiran
Prospective observational study. There is no treatment allocation. Patients who are receiving or intend to receive inclisiran are eligible to enroll into this study.
SoC cohort
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?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Percentage change in LDL-C from baseline
Time Frame: Baseline, month 4, month 22, month 34
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
Time Frame: Month 4, month 10, month 22, month 34
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
Time Frame: Month 4, month 10, month 22, month 34
Percentage of patients achieving LDL-C <70 mg/dL is collected
Month 4, month 10, month 22, month 34
Inclisiran cohort only: Mean PDC
Time Frame: 12 months, 24 months and 36 months
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
Time Frame: Baseline, month 12, month 24, month 36
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
Time Frame: Baseline, month 12, month 24, month 36

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
Time Frame: Month 12, month 24, month 36

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
Time Frame: Month 12, month 24, month 36

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

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Investigators

  • 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)

September 12, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

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 (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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