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

NCT05362903 | Completed

• 1 other identifier: CKJX839A1DE01
• Study Type: observational
• Target: 1,868
• Locations: 1 country
• Sites: 121

Brief 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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Inclisiran; Atherosclerotic Cardiovascular Disease; ASCVD

Outcome Measures

Primary Outcomes (7)

• Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis

  Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis is collected

  Baseline

• Number of patients with cardiovascular events

  Number of patients with cardiovascular events is collected

  Baseline

• Number of participants with concomitant medication in the previous 12 months

  Number of participants with concomitant medication in the previous 12 months is collected

  Baseline

• Number of apheresis treatments in the previous 12 months

  Number of apheresis treatments in the previous 12 months is collected

  Baseline

• Lipid lowering therapy used in the previous 12 months

  Lipid lowering therapy used in the previous 12 months is collected

  Baseline

• Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted

  Number of lipid apheresis conducted on Apheresis plus Inclisiran cohort is collected

  Baseline

• Low Density Lipoprotein cholesterol (LDL-C)

  Low Density Lipoprotein cholesterol (LDL-C) is collected

  Baseline

Secondary Outcomes (29)

• Number of In- and outpatient visits

  21 months

• Number of examinations

  21 months

• Number and types of lipid lowering treatments

  21 months

• Number of consultations

  21 months

• Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time

  21 months

Study Arms (3)

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

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

Other: Inclisiran

Apheresis plus Inclisiran

Patients who newly initiated Inclisiran on top of lipid apheresis

Other: Inclisiran

Interventions

Inclisiran OTHER

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

Apheresis plus Inclisiran; Inclisiran

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients with hypercholesterolemia newly initiated with oral LLT on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyramin), or new oral LLT alone in patients who are statin intolerant (Oral LLT Cohort), * Patients newly initiated with Inclisiran according to local reimbursement criteria (out of these, at least 60% naive to monoclonal antibodies targeting PCSK9) (Inclisiran Cohort) * Patients treated with Inclisiran on top of lipid apheresis from routine care (Apheresis plus Inclisiran Cohort).

You may qualify if:

• 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) or new oral LLT alone in case of statin intolerance or contraindication
• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (121)

Novartis Investigative Site

Freudenstadt, Baden-Wurttemberg, 72250, Germany

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Heidelberg, Baden-Wurttemberg, 69115, Germany

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Kirchheim unter Teck, Baden-Wurttemberg, 73230, Germany

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Konstanz, Baden-Wurttemberg, 78464, Germany

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Ulm, Baden-Wurttemberg, 89073, Germany

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Bayreuth, Bavaria, 95445, Germany

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Coburg, Bavaria, 96450, Germany

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Dachau, Bavaria, 85221, Germany

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Deggendorf, Bavaria, 94469, Germany

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Füssen, Bavaria, 87629, Germany

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Grünwald, Bavaria, 82031, Germany

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Landshut, Bavaria, 84034, Germany

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Marktoberdorf, Bavaria, 87616, Germany

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Muehldorf Am Inn, Bavaria, 84453, Germany

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Munich, Bavaria, 80331, Germany

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Munich, Bavaria, 80939, Germany

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Munich, Bavaria, 81925, Germany

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Neumarkt in der Oberpfalz, Bavaria, 92318, Germany

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Nuremberg, Bavaria, 90402, Germany

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Würzburg, Bavaria, 97080, Germany

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Burg, Brandenburg, 03096, Germany

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Eberswalde, Brandenburg, 16225, Germany

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Potsdam, Brandenburg, 14473, Germany

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Schwedt, Brandenburg, 16303, Germany

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Kassel, Hesse, 34121, Germany

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Offenbach, Hesse, 63065, Germany

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Rotenburg (Wümme), Lower Saxony, 27356, Germany

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Winsen, Lower Saxony, 21423, Germany

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Stralsund, Mecklenburg-Vorpommern, 18435, Germany

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Aachen, North Rhine-Westphalia, 52062, Germany

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Detmold, North Rhine-Westphalia, 32756, Germany

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Mülheim, North Rhine-Westphalia, 45468, Germany

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Münster, North Rhine-Westphalia, 48143, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Siegen, North Rhine-Westphalia, 57072, Germany

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Ingelheim, Rhineland-Palatinate, 55218, Germany

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Kaiserslautern, Rhineland-Palatinate, 67655, Germany

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Pirmasens, Rhineland-Palatinate, 66954, Germany

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Chemnitz, Saxony, 09113, Germany

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Chemnitz, Saxony, 09130, Germany

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Görlitz, Saxony, 02827, Germany

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Hohenstein-Ernstthal, Saxony, 09337, Germany

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Leipzig, Saxony, 04103, Germany

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Leipzig, Saxony, 04158, Germany

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Leipzig, Saxony, 04317, Germany

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Pirna, Saxony, 01796, Germany

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Halle, Saxony-Anhalt, 06108, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Quedlinburg, Saxony-Anhalt, 06484, Germany

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Salzatal, Saxony-Anhalt, 06198, Germany

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Wittenberg, Saxony-Anhalt, 06886, Germany

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Greiz, Thuringia, 07973, Germany

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Jena, Thuringia, 07740, Germany

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Altenburg, 04600, Germany

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Aue, 08280, Germany

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Bad Homburg, 61348, Germany

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Bad Nauheim, 61231, Germany

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Berlin, 10115, Germany

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Berlin, 10789, Germany

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Berlin, 12489, Germany

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Berlin, 12627, Germany

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Biedenkopf, 35216, Germany

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Borsdorf, 04451, Germany

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Brilon, 59929, Germany

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Brüel, 19412, Germany

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Chemnitz, 09116, Germany

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Chemnitz, 09130, Germany

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Cloppenburg, 49661, Germany

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Cologne, 50670, Germany

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Cologne, 51105, Germany

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Cuxhaven, 27476, Germany

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Dachau, 85221, Germany

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Darmstadt, 64287, Germany

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Dessau, 06846, Germany

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Dresden, 01129, Germany

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Ehingen, 89584, Germany

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Ehringshausen, 35630, Germany

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Novartis Investigative Site

Eisfeld, 98673, Germany

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Novartis Investigative Site

Frechen, 50226, Germany

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Fürth, 90766, Germany

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Greifswald, 17475, Germany

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Günzburg, 89312, Germany

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Hamburg, 22087, Germany

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Hamburg, 22459, Germany

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Hamburg, 22607, Germany

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Hamburg, 22769, Germany

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Haßloch, 67454, Germany

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Heide, 25746, Germany

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Kiel, 24105, Germany

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Ludwigshafen, 67071, Germany

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Mainz, 55126, Germany

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Mannheim, 68165, Germany

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Markkleeberg, 04416, Germany

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Moers, 47441, Germany

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München, 80333, Germany

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Münster, 48149, Germany

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Naumburg, 06618, Germany

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Neuruppin, 16816, Germany

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Olpe, 57462, Germany

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Oranienburg, 16515, Germany

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Oschatz, 04758, Germany

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Novartis Investigative Site

Osnabrück, 49080, Germany

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Osnabrück, 49088, Germany

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Papenburg, 26871, Germany

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Rendsburg, 24768, Germany

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Novartis Investigative Site

Riesa, 01589, Germany

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Novartis Investigative Site

Rostock, 18107, Germany

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Novartis Investigative Site

Schwandorf in Bayern, 92421, Germany

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Novartis Investigative Site

Speyer, 67346, Germany

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Stadtlohn, 48703, Germany

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Trier, 54292, Germany

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Novartis Investigative Site

Ulm, 89073, Germany

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Ulm, 89077, Germany

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Ulm, 89081, Germany

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Wermsdorf, 04779, Germany

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Wesel, 46485, Germany

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Winterberg, 59955, Germany

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Wismar, 23966, Germany

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Novartis Investigative Site

Wuppertal, 42289, Germany

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Novartis Investigative Site

Würzburg, 97070, Germany

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Novartis Investigative Site

Zwiesel, 94227, Germany

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MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: January 31, 2022
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (121)