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

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

Last Update: Jan 26, 2023

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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
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jan 28, 2022
Completion date 
Jan 31, 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 Locations

Germany
Novartis Investigative Site
Recruiting
Freudenstadt, 72250
Baden Wuerttemberg
Germany
Novartis Investigative Site
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Kirchheim,
Baden-Wuerttemberg
Germany
Novartis Investigative Site
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Konstanz, 78464
Baden-Wuerttemberg
Germany
Novartis Investigative Site
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Coburg,
Bavaria
Germany
Novartis Investigative Site
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Deggendorf, 94469
Bavaria
Germany
Novartis Investigative Site
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Marktoberdorf, 87616
Bavaria
Germany
Novartis Investigative Site
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Muenchen, 80331
Bavaria
Germany
Novartis Investigative Site
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Muenchen,
Bavaria
Germany
Novartis Investigative Site
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Wuerzburg, 97080
Bavaria
Germany
Novartis Investigative Site
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Burg, 03096
Brandenburg
Germany
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Potsdam, 14473
Brandenburg
Germany
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Rotenburg, 27356
Lower Saxony
Germany
Novartis Investigative Site
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Stralsund, 18435
Mecklenburg Vorpommern
Germany
Novartis Investigative Site
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Stralsund,
Mecklenburg-Vorpommern
Germany
Novartis Investigative Site
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Muenster, 48149
Northrhine Westfalia
Germany
Novartis Investigative Site
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Kaiserslautern, 67655
Rhineland-Palatinate
Germany
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Chemnitz, 09113
Saxony
Germany
Novartis Investigative Site
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Eberswalde, 16225
Saxony
Germany
Novartis Investigative Site
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Gorlitz, 02827
Saxony
Germany
Novartis Investigative Site
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Leipzig, 04317
Saxony
Germany
Novartis Investigative Site
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Pirna, 01796
Saxony
Germany
Novartis Investigative Site
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Siegen, 57072
Westfalia
Germany
Novartis Investigative Site
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Aachen, 52062
-
Germany
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Augsburg, 86150
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Germany
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Augsburg, 86156
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Germany
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Bayreuth, 85445
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Germany
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Berlin, 10789
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Germany
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Berlin,
-
Germany
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Borsdorf, 04451
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Germany
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Brilon, 59929
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Germany
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Brueel, 19412
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Germany
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Chemnitz, 09116
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Germany
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Chemnitz, 09130
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Germany
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Cloppenburg, 49661
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Germany
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Cologne, 51105
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Germany
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Dachau, 85221
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Germany
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Dachau, D-85221
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Germany
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Darmstadt, 64287
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Germany
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Dresden, 01129
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Germany
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Dresden, 01307
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Germany
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Ehringshausen, 35630
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Germany
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Fuerth, 90766
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Germany
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Greiz, D-07973
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Germany
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Gruenwald, 82031
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Germany
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Guenzburg, 89312
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Germany
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Halle Saale, 06120
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Germany
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Halle, D-06108
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Germany
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Hamburg, 22459
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Germany
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Hassloch, 67454
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Germany
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Heidelberg, 69115
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Germany
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Heide, 25746
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Germany
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Hohenstein-Ernstthal, 09337
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Germany
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Jena, 07740
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Germany
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Kassel, 34121
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Germany
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Koeln,
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Germany
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Königsbrück, 01436
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Germany
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Leipzig, 04103
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Germany
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Ludwigshafen, 67071
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Germany
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Lutherstadt Wittenberg, 06886
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Germany
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Lüneburg, 21339
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Germany
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Mannheim, 68165
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Germany
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Markkleeberg, 04416
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Germany
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Moers, 47441
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Germany
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Morsbach, 51597
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Germany
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Muehldorf, 84453
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Germany
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Muehlheim An Der Ruhr, 45468
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Germany
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Muenchen, 80333
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Germany
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Muenster, 48149
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Germany
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Munchen, 81925
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Germany
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München, 80335
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Germany
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Münster, 48143
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Germany
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Naumburg, 06618
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Germany
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Neumarkt, 92318
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Germany
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Neuruppin, 16816
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Germany
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Nürnberg, 90402
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Germany
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Offenbach, 63065
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Germany
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Oranienburg, 16515
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Germany
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Oschatz, 04758
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Germany
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Papenburg, 26871
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Germany
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Pirmasens, D-66954
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Germany
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Rendsburg, 24768
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Germany
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Riesa, 01589
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Germany
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Rostock, 18107
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Germany
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Salzatal, D-06198
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Germany
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Schwedt, 16303
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Germany
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Speyer, 67346
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Germany
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Stadtlohn, 48703
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Germany
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Ulm, 89073
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Germany
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Ulm, 89081
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Germany
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Villingen-Schwenningen, D78052
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Germany
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Wermsdorf, 04779
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Germany
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Wesel, 46485
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Germany
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Wismar, 23966
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Germany
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Zwenkau, 04442
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Germany
Novartis Investigative Site
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Zwiesel, 94227
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Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

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