Clinical trial NCT05399992: Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Keywords: primary hypercholesterolemia
mixed dyslipidemia
real-world study
inclisiran
lipid-lowering therapy
LLT
ASCVD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other LLTs under conditions of routine clinical practice.

Detailed description: Patients will be enrolled over a period of \~31.5 months, and followed for up to 24 months to assess for study outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in LDL-C from baseline to 10 months
timeFrame: Baseline, 10 months
Secondary outcomes:
measure: Percentage change in LDL-C from baseline
timeFrame: Baseline, month 4, month 16, month 22
measure: Percentage change in LDL-C from baseline by ≥50%
timeFrame: Month 4, month 10, month 16, month 22
measure: Percentage change in LDL-C from baseline by ≥30%
timeFrame: Month 4, month 10, month 16, month 22
measure: Inclisiran cohort : Mean PDC
timeFrame: 12 months and 24 months
measure: Proportion of participants remaining on initial baseline therapy
timeFrame: Baseline, month 12 and month 24
measure: Change from baseline in scores from the TSQM (modified) instrument
timeFrame: Baseline, month 12 and month 24
measure: Descriptive adherence data based on Adherence AAQ
timeFrame: Month 12 and month 24
measure: Descriptive adherence data based on ABQ
timeFrame: Month 12 and month 24
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: St Veit
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Shenzhen
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Holon
country: Israel
facility: Novartis Investigative Site
state: Gush Dan
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
state: Saudi
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Tabuk
country: Saudi Arabia
facility: Novartis Investigative Site
city: Fribourg
country: Switzerland
facility: Novartis Investigative Site
state: CH
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Geneve 14
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Olten
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Al Ain
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: High Wycombe
country: United Kingdom
facility: Novartis Investigative Site
state: Buckinghamshire
city: Louth
country: United Kingdom
facility: Novartis Investigative Site
state: Lincolnshire
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Bromwich
country: United Kingdom
facility: Novartis Investigative Site
city: Burton on Trent
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: Lancaster
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Middlesex
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: