The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 11 for:    victorion
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05399992
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Primary Hypercholesterolemia Mixed Dyslipidemia Other: Inclisiran

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : September 12, 2022
Estimated Primary Completion Date : April 1, 2027
Estimated Study Completion Date : April 1, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage change in LDL-C from baseline to 10 months [ Time Frame: Baseline, 10 months ]
    Percentage change in Low density lipoprotein - Cholesterol (LDL-C)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.


  7. 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).


  8. 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399992


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Layout table for location information
Austria
Novartis Investigative Site Recruiting
Linz, Oberoesterreich, Austria, A 4020
Novartis Investigative Site Recruiting
Feldkirch, Austria, 6807
Novartis Investigative Site Recruiting
Graz, Austria, A-8036
Novartis Investigative Site Recruiting
Linz, Austria, 4021
Novartis Investigative Site Recruiting
St. Veit, Austria, 5621
Novartis Investigative Site Recruiting
Wels, Austria, A-4600
Novartis Investigative Site Recruiting
Wien, Austria, A-1090
China, Guangdong
Novartis Investigative Site Recruiting
Shenzhen, Guangdong, China, 518000
Novartis Investigative Site Withdrawn
Shenzhen, Guangdong, China, 518000
Israel
Novartis Investigative Site Recruiting
Holon, Gush Dan, Israel, 5845997
Novartis Investigative Site Recruiting
Petach Tikva, Israel, 49100
Novartis Investigative Site Recruiting
Petach Tikva, Israel, 4941492
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 6801296
Malaysia
Novartis Investigative Site Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50470
Novartis Investigative Site Recruiting
Kuala Lumpur, Malaysia, 50400
Saudi Arabia
Novartis Investigative Site Recruiting
Riyadh, Saudi, Saudi Arabia, 11643
Novartis Investigative Site Recruiting
Jeddah, Saudi Arabia, 21159
Novartis Investigative Site Recruiting
Jeddah, Saudi Arabia, 21499
Novartis Investigative Site Recruiting
Tabuk, Saudi Arabia, 47512
Switzerland
Novartis Investigative Site Recruiting
Fribourg, CH, Switzerland, 1708
Novartis Investigative Site Recruiting
Basel, Switzerland, 4031
Novartis Investigative Site Recruiting
Geneve 14, Switzerland, 1211
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site Recruiting
Olten, Switzerland, 4600
Novartis Investigative Site Recruiting
St Gallen, Switzerland, 9007
Novartis Investigative Site Recruiting
Zuerich, Switzerland, 8032
Novartis Investigative Site Recruiting
Zuerich, Switzerland, 8091
United Arab Emirates
Novartis Investigative Site Recruiting
Kalba, Sharjah, United Arab Emirates
Novartis Investigative Site Recruiting
Abu Dhabi, United Arab Emirates, 112412
Novartis Investigative Site Recruiting
Abu Dhabi, United Arab Emirates
Novartis Investigative Site Recruiting
Al Ain, United Arab Emirates
Novartis Investigative Site Recruiting
Dubai, United Arab Emirates, 7272
Novartis Investigative Site Recruiting
Dubai, United Arab Emirates
United Kingdom
Novartis Investigative Site Recruiting
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TR
Novartis Investigative Site Recruiting
Lancaster, Lancashire, United Kingdom, LA1 4RP
Novartis Investigative Site Recruiting
Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
Novartis Investigative Site Recruiting
Belfast, United Kingdom, BT16 1RH
Novartis Investigative Site Recruiting
Bromwich, United Kingdom, B71 4HJ
Novartis Investigative Site Recruiting
Burton on Trent, United Kingdom, DE13 0RB
Novartis Investigative Site Recruiting
Cardiff, United Kingdom, CF14 4XW
Novartis Investigative Site Recruiting
Hull, United Kingdom, HU3 2JZ
Novartis Investigative Site Recruiting
Liverpool, United Kingdom, L7 8XP
Novartis Investigative Site Recruiting
London, United Kingdom, NW3 2QG
Novartis Investigative Site Recruiting
Middlesex, United Kingdom, UB9 6JH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05399992    
Other Study ID Numbers: CKJX839A12401
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: February 2024
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
primary hypercholesterolemia
mixed dyslipidemia
real-world study
inclisiran
 lipid-lowering therapy
LLT
ASCVD
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases