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: May 11, 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 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.
Other
Inclisiran
Prospective observational cohort study. There is no treatment allocation. Patients administered Inclisiran by prescription will be enrolled.
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
Recruiting
Konstanz, 78464
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Muenchen,
Bavaria
Germany
Novartis Investigative Site
Recruiting
Stralsund, 18435
Mecklenburg Vorpommern
Germany
Novartis Investigative Site
Recruiting
Kaiserslautern, 67655
Rhineland-Palatinate
Germany
Novartis Investigative Site
Recruiting
Eberswalde, 16225
Saxony
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04317
Saxony
Germany
Novartis Investigative Site
Recruiting
Pirna, 01796
Saxony
Germany
Novartis Investigative Site
Recruiting
Berlin, 10789
-
Germany
Novartis Investigative Site
Recruiting
Berlin,
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09116
-
Germany
Novartis Investigative Site
Recruiting
Cologne, 51105
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Halle Saale, 06120
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22459
-
Germany
Novartis Investigative Site
Recruiting
Koeln,
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Lüneburg, 21339
-
Germany
Novartis Investigative Site
Recruiting
Mannheim, 68165
-
Germany
Novartis Investigative Site
Recruiting
Markkleeberg, 04416
-
Germany
Novartis Investigative Site
Recruiting
Moers, 47441
-
Germany
Novartis Investigative Site
Recruiting
Morsbach, 51597
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Münster, 48143
-
Germany
Novartis Investigative Site
Recruiting
Offenbach, 63065
-
Germany
Novartis Investigative Site
Recruiting
Oschatz, 04758
-
Germany
Novartis Investigative Site
Recruiting
Papenburg, 26871
-
Germany
Novartis Investigative Site
Recruiting
Pirmasens, D-66954
-
Germany
Novartis Investigative Site
Recruiting
Riesa, 01589
-
Germany
Novartis Investigative Site
Recruiting
Rostock, 18107
-
Germany
Novartis Investigative Site
Recruiting
Salzatal, D-06198
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89073
-
Germany
Novartis Investigative Site
Recruiting
Wermsdorf, 04779
-
Germany
Novartis Investigative Site
Recruiting
Wesel, 46485
-
Germany
Novartis Investigative Site
Recruiting
Freudenstadt, 72250
Baden Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Konstanz, 78464
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Muenchen,
Bavaria
Germany
Novartis Investigative Site
Recruiting
Stralsund, 18435
Mecklenburg Vorpommern
Germany
Novartis Investigative Site
Recruiting
Stralsund,
Mecklenburg-Vorpommern
Germany
Novartis Investigative Site
Recruiting
Kaiserslautern, 67655
Rhineland-Palatinate
Germany
Novartis Investigative Site
Recruiting
Eberswalde, 16225
Saxony
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04317
Saxony
Germany
Novartis Investigative Site
Recruiting
Pirna, 01796
Saxony
Germany
Novartis Investigative Site
Recruiting
Berlin, 10789
-
Germany
Novartis Investigative Site
Recruiting
Berlin,
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09116
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09130
-
Germany
Novartis Investigative Site
Recruiting
Cologne, 51105
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Halle Saale, 06120
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22459
-
Germany
Novartis Investigative Site
Recruiting
Koeln,
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Lüneburg, 21339
-
Germany
Novartis Investigative Site
Recruiting
Mannheim, 68165
-
Germany
Novartis Investigative Site
Recruiting
Markkleeberg, 04416
-
Germany
Novartis Investigative Site
Recruiting
Moers, 47441
-
Germany
Novartis Investigative Site
Recruiting
Morsbach, 51597
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Münster, 48143
-
Germany
Novartis Investigative Site
Recruiting
Offenbach, 63065
-
Germany
Novartis Investigative Site
Recruiting
Oschatz, 04758
-
Germany
Novartis Investigative Site
Recruiting
Papenburg, 26871
-
Germany
Novartis Investigative Site
Recruiting
Pirmasens, D-66954
-
Germany
Novartis Investigative Site
Recruiting
Riesa, 01589
-
Germany
Novartis Investigative Site
Recruiting
Rostock, 18107
-
Germany
Novartis Investigative Site
Recruiting
Salzatal, D-06198
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89073
-
Germany
Novartis Investigative Site
Recruiting
Wermsdorf, 04779
-
Germany
Novartis Investigative Site
Recruiting
Wesel, 46485
-
Germany
Novartis Investigative Site
Recruiting
Freudenstadt, 72250
Baden Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Konstanz, 78464
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Muenchen,
Bavaria
Germany
Novartis Investigative Site
Recruiting
Stralsund, 18435
Mecklenburg Vorpommern
Germany
Novartis Investigative Site
Recruiting
Stralsund,
Mecklenburg-Vorpommern
Germany
Novartis Investigative Site
Recruiting
Kaiserslautern, 67655
Rhineland-Palatinate
Germany
Novartis Investigative Site
Recruiting
Eberswalde, 16225
Saxony
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04317
Saxony
Germany
Novartis Investigative Site
Recruiting
Pirna, 01796
Saxony
Germany
Novartis Investigative Site
Recruiting
Berlin, 10789
-
Germany
Novartis Investigative Site
Recruiting
Berlin,
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09116
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09130
-
Germany
Novartis Investigative Site
Recruiting
Cologne, 51105
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Halle Saale, 06120
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22459
-
Germany
Novartis Investigative Site
Recruiting
Koeln,
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Lüneburg, 21339
-
Germany
Novartis Investigative Site
Recruiting
Mannheim, 68165
-
Germany
Novartis Investigative Site
Recruiting
Markkleeberg, 04416
-
Germany
Novartis Investigative Site
Recruiting
Moers, 47441
-
Germany
Novartis Investigative Site
Recruiting
Morsbach, 51597
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Münster, 48143
-
Germany
Novartis Investigative Site
Recruiting
Offenbach, 63065
-
Germany
Novartis Investigative Site
Recruiting
Oschatz, 04758
-
Germany
Novartis Investigative Site
Recruiting
Papenburg, 26871
-
Germany
Novartis Investigative Site
Recruiting
Pirmasens, D-66954
-
Germany
Novartis Investigative Site
Recruiting
Riesa, 01589
-
Germany
Novartis Investigative Site
Recruiting
Rostock, 18107
-
Germany
Novartis Investigative Site
Recruiting
Salzatal, D-06198
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89073
-
Germany
Novartis Investigative Site
Recruiting
Wermsdorf, 04779
-
Germany
Novartis Investigative Site
Recruiting
Wesel, 46485
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

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