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

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

Last Update: Nov 15, 2022

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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.

Condition 
Primary Hypercholesterolemia
Mixed Dyslipidemia
Phase 
Not Given
Overall status 
Recruiting
Start date 
Sep 12, 2022
Completion date 
Apr 01, 2027
Gender 
All
Age(s)
18 Years and older (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 Locations

Switzerland
Novartis Investigative Site
Recruiting
Geneve 14, 1211
-
Switzerland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]