A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting

Last Update: Mar 20, 2024

A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting (VICTORION-Implement)

ClinicalTrials.gov Identifier:

NCT05362903

Novartis Reference Number:CKJX839A1DE01

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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 is a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral Lipid lowering treatment on top of a statin (Oral LLT cohort), newly initiated Inclisiran (Inclisiran cohort) and newly initiated Inclisiran on top of lipid apheresis (Apheresis plus Inclisiran cohort) in routine clinical care. All procedures, treatment adaptions and laboratory assessments are part of clinicla routine and conducted independent of this study.

Condition

Hypercholesterolemia

Overall Status

Recruiting

Number of Participants

2030

Start Date

Jan 28, 2022

Completion Date

Dec 01, 2025

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

Inclisiran

Prospective observational cohort study. There is no treatment allocation. Patients administered Inclisiran by prescription will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Patients who provide written informed consent to participate in the study
Male or female patients ≥ 18 years of age
Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin)
Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).

Exclusion Criteria:

Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
Contraindication for Inclisiran according to the SmPC
Patients who have received Inclisiran previously
Patients with homozygous FH
Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
Simultaneous or planned participation in an interventional research study

Study Location

Novartis Investigative Site

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Schwedt,16303,Germany

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Markkleeberg,04416,Germany

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Dessau-Roßlau,06846,Germany

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Berlin,10115,Germany

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Ulm,89081,Germany

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Neumarkt,92318,Germany

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Greifswald,17475,Germany

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Cloppenburg,49661,Germany

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Quedlinburg,Saxony Anhalt,06484,Germany

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Heidelberg,69115,Germany

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Leipzig,Saxony,04317,Germany

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Augsburg,86150,Germany

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Muenchen,80634,Germany

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Emmendingen,79312,Germany

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Brueel,19412,Germany

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Witten,North Rhine-WestPhalia,58455,Germany

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Osnabrueck,49080,Germany

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Halle,D-06108,Germany

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Koeln,50670,Germany

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Detmold,NRW,32756,Germany

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Siegen,Westfalia,57072,Germany

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Marktoberdorf,Bavaria,87616,Germany

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Ingelheim,55218,Germany

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Berlin,10178,Germany

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Viersen,41749,Germany

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Neuruppin,16816,Germany

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Greiz,D-07973,Germany

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Coburg,Bavaria,96450,Germany

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Rendsburg,24768,Germany

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Heide,25746,Germany

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Ludwigshafen,67071,Germany

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Essen,45136,Germany

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Augsburg,86156,Germany

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Muenster,Northrhine Westfalia,48149,Germany

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Königsbrück,01436,Germany

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Burg,Brandenburg,03096,Germany

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Wuerzburg,97080,Germany

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Papenburg,26871,Germany

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Hamburg,22087,Germany

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Dresden,01129,Germany

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Speyer,67346,Germany

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Moers,47441,Germany

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Greiz,Thueringen,07937,Germany

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Jena,07740,Germany

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Berlin,10789,Germany

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Villingen-Schwenningen,D78052,Germany

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Nürnberg,90402,Germany

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Lüneburg,21339,Germany

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Dachau,85221,Germany

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Riesa,01589,Germany

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Hohenstein-Ernstthal,09337,Germany

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Freudenstadt,Baden Wuerttemberg,72250,Germany

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Bad Homburg,61348,Germany

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Hamburg,22459,Germany

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Konstanz,Baden-Wuerttemberg,78464,Germany

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Chemnitz,09116,Germany

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Passau,94032,Germany

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Muehldorf,84453,Germany

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Dresden,01307,Germany

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Stadtlohn,48703,Germany

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Gruenwald,82031,Germany

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Kaiserslautern,Rhineland-Palatinate,67655,Germany

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Berlin,12489,Germany

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Wermsdorf,04779,Germany

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Offenbach,63065,Germany

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Lutherstadt Wittenberg,06886,Germany

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Dachau,D-85221,Germany

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Rostock,18107,Germany

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München,80335,Germany

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Fuerth,90766,Germany

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Bad Nauheim,61231,Germany

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Hamburg,22607,Germany

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Landshut,Bavaria,84034,Germany

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Chemnitz,Saxonia,09130,Germany

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Zwenkau,04442,Germany

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Pirmasens,D-66954,Germany

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Muehlheim An Der Ruhr,45468,Germany

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Eberswalde,Saxony,16225,Germany

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Stralsund,Mecklenburg Vorpommern,18435,Germany

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Aachen,52062,Germany

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Olpe,57462,Germany

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Guenzburg,89312,Germany

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Kassel,34121,Germany

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Berlin,12627,Germany

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Wesel,46485,Germany

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Mainz,55126,Germany

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Darmstadt,64287,Germany

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Rotenburg,Lower Saxony,27356,Germany

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Munchen,81925,Germany

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Fussen,87629,Germany

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Bad Salzuflen,Northrhine Westfalia,32105,Germany

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Pirna,Saxony,01796,Germany

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Hamburg,22769,Germany

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Leipzig,04103,Germany

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Zwiesel,94227,Germany

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Altenburg,04600,Germany

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Muenchen,Bavaria,80331,Germany

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Ehingen,89584,Germany

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Trier,54292,Germany

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Winterberg,59955,Germany

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Oranienburg,16515,Germany

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Hachenburg,57627,Germany

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Kiel,24105,Germany

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Biedenkopf,35216,Germany

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Salzatal,D-06198,Germany

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Mannheim,68165,Germany

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Deggendorf,Bavaria,94469,Germany

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Bayreuth,85445,Germany

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Ulm,89077,Germany

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Naumburg,06618,Germany

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Gorlitz,Saxony,02827,Germany

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Potsdam,Brandenburg,14473,Germany

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Hassloch,67454,Germany

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Leipzig,04158,Germany

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Chemnitz,Saxony,09113,Germany

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Ulm,89073,Germany

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Aue,08280,Germany

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Muenchen,Bavaria,80939,Germany

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Eisfeld,98673,Germany

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Brilon,59929,Germany

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Wismar,23966,Germany

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Oschatz,04758,Germany

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Halle Saale,06120,Germany

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Kirchheim,Baden-Wuerttemberg,73230,Germany

Worldwide Contacts

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

Novartis Pharmaceuticals

Phone: +41613241111

Email: [email protected]