Last Update: Mar 04, 2024
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
ClinicalTrials.gov Identifier:
NCT05399992
Novartis Reference Number:CKJX839A12401
See if you Pre-qualify
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

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

Primary Hypercholesterolemia, Mixed Dyslipidemia
Recruiting
2100
Sep 12, 2022
Apr 01, 2027
All
18 Years - (Adult, Older Adult)

Interventions

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.

Eligibility Criteria

Inclusion Criteria:

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

Cohort-specific:

Inclisiran Cohort

- Patients who initiate inclisiran under conditions per local label

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:

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

Study Location

Novartis Investigative Site

Recruiting

Feldkirch,6807,Austria

Novartis Investigative Site

Recruiting

Linz,4021,Austria

Novartis Investigative Site

Recruiting

Linz,Oberoesterreich,A 4020,Austria

Novartis Investigative Site

Recruiting

Graz,A-8036,Austria

Novartis Investigative Site

Recruiting

Wels,A-4600,Austria

Novartis Investigative Site

Recruiting

Wien,A-1090,Austria

Novartis Investigative Site

Recruiting

St. Veit,5621,Austria

Novartis Investigative Site

Recruiting

Shenzhen,Guangdong,518000,China

Novartis Investigative Site

Recruiting

Petach Tikva,49100,Israel

Novartis Investigative Site

Recruiting

Petach Tikva,4941492,Israel

Novartis Investigative Site

Recruiting

Tel Aviv,6801296,Israel

Novartis Investigative Site

Recruiting

Holon,Gush Dan,5845997,Israel

Novartis Investigative Site

Recruiting

Kuala Lumpur,50400,Malaysia

Novartis Investigative Site

Recruiting

Kuala Lumpur,Wilayah Persekutuan,50470,Malaysia

Novartis Investigative Site

Recruiting

Jeddah,21159,Saudi Arabia

Novartis Investigative Site

Recruiting

Tabuk,47512,Saudi Arabia

Novartis Investigative Site

Recruiting

Jeddah,21499,Saudi Arabia

Novartis Investigative Site

Recruiting

Riyadh,Saudi,11643,Saudi Arabia

Novartis Investigative Site

Recruiting

Zuerich,8091,Switzerland

Novartis Investigative Site

Recruiting

Lausanne,1011,Switzerland

Novartis Investigative Site

Recruiting

Fribourg,CH,1708,Switzerland

Novartis Investigative Site

Recruiting

Geneve 14,1211,Switzerland

Novartis Investigative Site

Recruiting

St Gallen,9007,Switzerland

Novartis Investigative Site

Recruiting

Zuerich,8032,Switzerland

Novartis Investigative Site

Recruiting

Basel,4031,Switzerland

Novartis Investigative Site

Recruiting

Olten,4600,Switzerland

Novartis Investigative Site

Recruiting

Al Ain,United Arab Emirates

Novartis Investigative Site

Recruiting

Abu Dhabi,112412,United Arab Emirates

Novartis Investigative Site

Recruiting

Dubai,7272,United Arab Emirates

Novartis Investigative Site

Recruiting

Sunderland,Tyne And Wear,SR4 7TP,United Kingdom

Novartis Investigative Site

Recruiting

Belfast,BT16 1RH,United Kingdom

Novartis Investigative Site

Recruiting

Bromwich,B71 4HJ,United Kingdom

Novartis Investigative Site

Recruiting

Burton on Trent,DE13 0RB,United Kingdom

Novartis Investigative Site

Recruiting

Liverpool,L7 8XP,United Kingdom

Novartis Investigative Site

Recruiting

Cardiff,CF14 4XW,United Kingdom

Novartis Investigative Site

Recruiting

High Wycombe,Buckinghamshire,HP11 2TR,United Kingdom

Novartis Investigative Site

Recruiting

London,NW3 2QG,United Kingdom

Novartis Investigative Site

Recruiting

Middlesex,UB9 6JH,United Kingdom

Novartis Investigative Site

Recruiting

Lancaster,Lancashire,LA1 4RP,United Kingdom

Novartis Investigative Site

Recruiting

Hull,HU3 2JZ,United Kingdom

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111