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

Last updated: April 22, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Treatment

Inclisiran

Clinical Study ID

NCT05362903
CKJX839A1DE01
  • Ages 18-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who provide written informed consent to participate in the study

  2. Male or female patients ≥ 18 years of age

  3. Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipidlowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid,cholestyraimin)

  4. Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restrictedreimbursement criteria or individual access requirements who are not at LDL-C goalas 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

  5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weeklyor bi-weekly lipoprotein apheresis (LDL-c or LP(a)).

Exclusion

Exclusion Criteria:

  1. Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy

  2. Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment

  3. Contraindication for Inclisiran according to the SmPC

  4. Patients who have received Inclisiran previously

  5. Patients with homozygous FH

  6. Any underlying known disease, or surgical, physical, or medical condition that, inthe opinion of the investigator (or delegate) might interfere with interpretation ofthe clinical study results.

  7. Simultaneous or planned participation in an interventional research study

Study Design

Total Participants: 2030
Treatment Group(s): 1
Primary Treatment: Inclisiran
Phase:
Study Start date:
January 28, 2022
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Novartis Investigative Site

    Freudenstadt, Baden Wuerttemberg 72250
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Heidelberg, Baden Wuerttemberg 69115
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kirchheim, Baden-Wuerttemberg 73230
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kirchheim Unter Teck, Baden-Wuerttemberg 73230
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Konstanz, Baden-Wuerttemberg 78464
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Coburg, Bavaria 96450
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Deggendorf, Bavaria 94469
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Marktoberdorf, Bavaria 87616
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Fuessen, Bayern 87629
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gruenwald, Bayern 82031
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Landshut, Bayern 84034
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Burg, Brandenburg 03096
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Potsdam, Brandenburg 14473
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kassel, Hessen 34121
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Rotenburg, Lower Saxony 27356
    Germany

    Site Not Available

  • Novartis Investigative Site

    Winsen, Lower Saxony 21423
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stralsund, Mecklenburg Vorpommern 18435
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Detmold, NRW 32756
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Salzuflen, Nordrhein-Westfalen 32105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Witten, North Rhine-WestPhalia 58455
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ingelheim, Rheinland Pfalz 55218
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kaiserslautern, Rheinland-Pfalz 67655
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Eberswalde, Sachsen 16225
    Germany

    Site Not Available

  • Novartis Investigative Site

    Goerlitz, Sachsen 02827
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hohenstein-Ernstthal, Sachsen 09337
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Halle Saale, Sachsen-Anhalt 06108
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Chemnitz, Saxonia 09130
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gorlitz, Saxony 02827
    Germany

    Site Not Available

  • Novartis Investigative Site

    Pirna, Saxony 01796
    Germany

    Site Not Available

  • Novartis Investigative Site

    Quedlinburg, Saxony Anhalt 06484
    Germany

    Site Not Available

  • Novartis Investigative Site

    Greiz, Thueringen 07937
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Siegen, Westfalia 57072
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Aachen, 52062
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Altenburg, 04600
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Aue, 08280
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Augsburg, 86156
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Homburg, 61348
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Nauheim, 61231
    Germany

    Completed

  • Novartis Investigative Site

    Bayreuth, 85445
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 12627
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Biedenkopf, 35216
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Borsdorf, 04451
    Germany

    Completed

  • Novartis Investigative Site

    Brilon, 59929
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Brueel, 19412
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Cloppenburg, 49661
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cologne, 51105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cuxhaven, 27476
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dachau, 85221
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Darmstadt, 64287
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dessau-Rosslau, 06846
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dessau-Roßlau, 06846
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ehingen, 89584
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ehringshausen, 35630
    Germany

    Completed

  • Novartis Investigative Site

    Eisfeld, 98673
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Emmendingen, 79312
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45136
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frechen, 50226
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Fuerth, 90766
    Germany

    Site Not Available

  • Novartis Investigative Site

    Fussen, 87629
    Germany

    Site Not Available

  • Novartis Investigative Site

    Greifswald, 17475
    Germany

    Site Not Available

  • Novartis Investigative Site

    Guenzburg, 89312
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hachenburg, 57627
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle, D-06108
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle S, 06120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22607
    Germany

    Completed

  • Novartis Investigative Site

    Hassloch, 67454
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Heide, 25746
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hennigsdorf, 16761
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hohenstein Ernstthal, 09337
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, 07740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel, 24105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50670
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Koenigsbrueck, 01936
    Germany

    Site Not Available

  • Novartis Investigative Site

    Königsbrück, 01436
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ludwigshafen, 67071
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Lueneburg, 21339
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lutherstadt Wittenberg, 06886
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Lüneburg, 21339
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55126
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Mannheim, 68165
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Markkleeberg, 04416
    Germany

    Site Not Available

  • Novartis Investigative Site

    Moers, 47441
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Morsbach, 51597
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muehldorf, 84453
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muehlheim An Der Ruhr, 45468
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Muenchen, 80335
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Munchen, 81925
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Munster, 48143
    Germany

    Completed

  • Novartis Investigative Site

    München, 80335
    Germany

    Site Not Available

  • Novartis Investigative Site

    Münster, 48143
    Germany

    Site Not Available

  • Novartis Investigative Site

    Naumburg, 06618
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Neumarkt, 92318
    Germany

    Completed

  • Novartis Investigative Site

    Neuruppin, 16816
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Nuernberg, 90402
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nürnberg, 90402
    Germany

    Site Not Available

  • Novartis Investigative Site

    Offenbach, 63065
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Olpe, 57462
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Oranienburg, 16515
    Germany

    Completed

  • Novartis Investigative Site

    Oschatz, 04758
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Osnabrueck, 49088
    Germany

    Site Not Available

  • Novartis Investigative Site

    Papenburg, 26871
    Germany

    Site Not Available

  • Novartis Investigative Site

    Passau, 94032
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Pirmasens, D-66954
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Rendsburg, 24768
    Germany

    Completed

  • Novartis Investigative Site

    Riesa, 01589
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Rostock, 18107
    Germany

    Site Not Available

  • Novartis Investigative Site

    Salzatal, D-06198
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Schwandorf, 92421
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Schwedt, 16303
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Speyer, 67346
    Germany

    Completed

  • Novartis Investigative Site

    Stadtlohn, 48703
    Germany

    Site Not Available

  • Novartis Investigative Site

    Trier, 54292
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    Viersen, 41749
    Germany

    Site Not Available

  • Novartis Investigative Site

    Villingen-Schwenningen, D78052
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wermsdorf, 04779
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wesel, 46485
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Winterberg, 59955
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wismar, 23966
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wuerzburg, 97070
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wuppertal, 42289
    Germany

    Completed

  • Novartis Investigative Site

    Zwenkau, 04442
    Germany

    Site Not Available

  • Novartis Investigative Site

    Zwiesel, 94227
    Germany

    Site Not Available

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