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

NCT ID: NCT05362903

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1871 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-28

Study Completion Date

2025-11-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral LLT

Patients with documented ASCVD not at individual LDL-C goal and newly initiated on an oral lipid lowering treatment on top of a statin, or alone in patients who are statin-intolerant, or for whom a statin is contraindicated

No interventions assigned to this group

Inclisiran

Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at their individual LDL-C goal as per their CV risk. Two individual sub-cohorts are analysed: 1. Inclisiran in a PCSK9-treatment naive cohort 2. Inclisiran in patients with prior PCSK9 antibody treatment

Inclisiran

Intervention Type OTHER

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

Apheresis plus Inclisiran

Patients who newly initiated Inclisiran on top of lipid apheresis

Inclisiran

Intervention Type OTHER

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

Interventions

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Inclisiran

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

Intervention Type OTHER

Eligibility Criteria

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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 lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin) or new oral LLT alone in case of statin intolerance or contraindication
4. 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
5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).

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, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
7. Simultaneous or planned participation in an interventional research study
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Biedenkopf, , Germany

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Novartis Investigative Site

Cologne, , Germany

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Cologne, , Germany

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Cuxhaven, , Germany

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Dachau, , Germany

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Darmstadt, , Germany

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Dessau, , Germany

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Dresden, , Germany

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Ehingen, , Germany

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Ehringshausen, , Germany

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Eisfeld, , Germany

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Frechen, , Germany

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Fürth, , Germany

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Greifswald, , Germany

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Günzburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Haßloch, , Germany

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Heide, , Germany

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Hennigsdorf, , Germany

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Kiel, , Germany

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Ludwigshafen, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Markkleeberg, , Germany

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Moers, , Germany

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München, , Germany

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Münster, , Germany

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Naumburg, , Germany

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Neumarkt, , Germany

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Neuruppin, , Germany

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Nuremberg, , Germany

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Offenbach, , Germany

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Olpe, , Germany

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Oranienburg, , Germany

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Oschatz, , Germany

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Osnabrück, , Germany

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Osnabrück, , Germany

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Papenburg, , Germany

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Pirmasens, , Germany

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Rendsburg, , Germany

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Riesa, , Germany

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Rostock, , Germany

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Salzatal, , Germany

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Schwandorf in Bayern, , Germany

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Schwedt, , Germany

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Speyer, , Germany

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Stadtlohn, , Germany

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Trier, , Germany

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Ulm, , Germany

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Ulm, , Germany

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Ulm, , Germany

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Wermsdorf, , Germany

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Wesel, , Germany

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Winterberg, , Germany

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Wismar, , Germany

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Wuppertal, , Germany

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Würzburg, , Germany

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Zwiesel, , Germany

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Borsdorf, , Germany

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Brilon, , Germany

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Brüel, , Germany

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Chemnitz, , Germany

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Chemnitz, , Germany

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Cloppenburg, , Germany

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Freudenstadt, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Kirchheim unter Teck, Baden-Wurttemberg, Germany

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Konstanz, Baden-Wurttemberg, Germany

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Coburg, Bavaria, Germany

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Dachau, Bavaria, Germany

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Deggendorf, Bavaria, Germany

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Füssen, Bavaria, Germany

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Grünwald, Bavaria, Germany

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Landshut, Bavaria, Germany

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Marktoberdorf, Bavaria, Germany

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Muehldorf Am Inn, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Burg, Brandenburg, Germany

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Potsdam, Brandenburg, Germany

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Kassel, Hesse, Germany

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Rotenburg (Wümme), Lower Saxony, Germany

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Winsen, Lower Saxony, Germany

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Stralsund, Mecklenburg-Vorpommern, Germany

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Aachen, North Rhine-Westphalia, Germany

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Detmold, North Rhine-Westphalia, Germany

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Mülheim, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Ingelheim, Rhineland-Palatinate, Germany

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Kaiserslautern, Rhineland-Palatinate, Germany

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Chemnitz, Saxony, Germany

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Chemnitz, Saxony, Germany

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Eberswalde, Saxony, Germany

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Görlitz, Saxony, Germany

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Hohenstein-Ernstthal, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Pirna, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Halle, Saxony-Anhalt, Germany

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Quedlinburg, Saxony-Anhalt, Germany

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Greiz, Thuringia, Germany

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Jena, Thuringia, Germany

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Siegen, Westfalia, Germany

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Lutherstadt Witten, Wittenberg, Germany

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Altenburg, , Germany

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Aue, , Germany

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Bad Homburg, , Germany

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Bad Nauheim, , Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Countries

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Germany

Other Identifiers

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CKJX839A1DE01

Identifier Type: -

Identifier Source: org_study_id

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