Last Update: Jun 27, 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
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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. 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
May 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:

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

Novartis Investigative Site

Recruiting

St Veit,5621,Austria

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Wels,A-4600,Austria

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Wien,A-1090,Austria

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Linz,Oberoesterreich,A 4020,Austria

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Feldkirch,6807,Austria

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Graz,A-8036,Austria

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Linz,4021,Austria

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Shenzhen,Guangdong,518000,China

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Petach Tikva,4941492,Israel

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Tel Aviv,6801296,Israel

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Holon,Gush Dan,5845997,Israel

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Petach Tikva,49100,Israel

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Kuala Lumpur,Wilayah Persekutuan,50470,Malaysia

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Kuala Lumpur,50400,Malaysia

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Tabuk,47512,Saudi Arabia

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Riyadh,Saudi,11643,Saudi Arabia

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Jeddah,21159,Saudi Arabia

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Jeddah,21499,Saudi Arabia

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St Gallen,9007,Switzerland

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Zuerich,8032,Switzerland

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Fribourg,CH,1708,Switzerland

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Zuerich,8091,Switzerland

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Basel,4031,Switzerland

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Geneve 14,1211,Switzerland

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Lausanne,1011,Switzerland

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Olten,4600,Switzerland

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Dubai,7272,United Arab Emirates

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Al Ain,United Arab Emirates

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Abu Dhabi,112412,United Arab Emirates

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London,Nw3 2qg,United Kingdom

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Bromwich,B71 4hj,United Kingdom

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Middlesex,Ub9 6jh,United Kingdom

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Burton on Trent,De13 0rb,United Kingdom

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Cardiff,Cf14 4xw,United Kingdom

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High Wycombe,Buckinghamshire,Hp11 2tr,United Kingdom

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Hull,Hu3 2jz,United Kingdom

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Lancaster,Lancashire,La1 4rp,United Kingdom

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Liverpool,L7 8xp,United Kingdom

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Sunderland,Tyne And Wear,Sr4 7tp,United Kingdom

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London,Ec1a 7be,United Kingdom

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Belfast,Bt16 1rh,United Kingdom

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+41613241111