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)

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Other: Inclisiran

• Study Type: Observational
• Enrollment (Actual): 1868

Contacts and Locations

Study Locations

• Germany
  • Altenburg, Germany, 04600
    • Novartis Investigative Site
  • Aue, Germany, 08280
    • Novartis Investigative Site
  • Bad Homburg, Germany, 61348
    • Novartis Investigative Site
  • Bad Nauheim, Germany, 61231
    • Novartis Investigative Site
  • Berlin, Germany, 12627
    • Novartis Investigative Site
  • Berlin, Germany, 10789
    • Novartis Investigative Site
  • Berlin, Germany, 10115
    • Novartis Investigative Site
  • Berlin, Germany, 12489
    • Novartis Investigative Site
  • Biedenkopf, Germany, 35216
    • Novartis Investigative Site
  • Borsdorf, Germany, 04451
    • Novartis Investigative Site
  • Brilon, Germany, 59929
    • Novartis Investigative Site
  • Brüel, Germany, 19412
    • Novartis Investigative Site
  • Chemnitz, Germany, 09130
    • Novartis Investigative Site
  • Chemnitz, Germany, 09116
    • Novartis Investigative Site
  • Cloppenburg, Germany, 49661
    • Novartis Investigative Site
  • Cologne, Germany, 51105
    • Novartis Investigative Site
  • Cologne, Germany, 50670
    • Novartis Investigative Site
  • Cuxhaven, Germany, 27476
    • Novartis Investigative Site
  • Dachau, Germany, 85221
    • Novartis Investigative Site
  • Darmstadt, Germany, 64287
    • Novartis Investigative Site
  • Dessau, Germany, 06846
    • Novartis Investigative Site
  • Dresden, Germany, 01129
    • Novartis Investigative Site
  • Ehingen, Germany, 89584
    • Novartis Investigative Site
  • Ehringshausen, Germany, 35630
    • Novartis Investigative Site
  • Eisfeld, Germany, 98673
    • Novartis Investigative Site
  • Frechen, Germany, 50226
    • Novartis Investigative Site
  • Fürth, Germany, 90766
    • Novartis Investigative Site
  • Greifswald, Germany, 17475
    • Novartis Investigative Site
  • Günzburg, Germany, 89312
    • Novartis Investigative Site
  • Hamburg, Germany, 22607
    • Novartis Investigative Site
  • Hamburg, Germany, 22087
    • Novartis Investigative Site
  • Hamburg, Germany, 22459
    • Novartis Investigative Site
  • Hamburg, Germany, 22769
    • Novartis Investigative Site
  • Haßloch, Germany, 67454
    • Novartis Investigative Site
  • Heide, Germany, 25746
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Ludwigshafen, Germany, 67071
    • Novartis Investigative Site
  • Mainz, Germany, 55126
    • Novartis Investigative Site
  • Mannheim, Germany, 68165
    • Novartis Investigative Site
  • Markkleeberg, Germany, 04416
    • Novartis Investigative Site
  • Moers, Germany, 47441
    • Novartis Investigative Site
  • München, Germany, 80333
    • Novartis Investigative Site
  • Münster, Germany, 48149
    • Novartis Investigative Site
  • Naumburg, Germany, 06618
    • Novartis Investigative Site
  • Neuruppin, Germany, 16816
    • Novartis Investigative Site
  • Olpe, Germany, 57462
    • Novartis Investigative Site
  • Oranienburg, Germany, 16515
    • Novartis Investigative Site
  • Oschatz, Germany, 04758
    • Novartis Investigative Site
  • Osnabrück, Germany, 49080
    • Novartis Investigative Site
  • Osnabrück, Germany, 49088
    • Novartis Investigative Site
  • Papenburg, Germany, 26871
    • Novartis Investigative Site
  • Rendsburg, Germany, 24768
    • Novartis Investigative Site
  • Riesa, Germany, 01589
    • Novartis Investigative Site
  • Rostock, Germany, 18107
    • Novartis Investigative Site
  • Schwandorf in Bayern, Germany, 92421
    • Novartis Investigative Site
  • Speyer, Germany, 67346
    • Novartis Investigative Site
  • Stadtlohn, Germany, 48703
    • Novartis Investigative Site
  • Trier, Germany, 54292
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
  • Ulm, Germany, 89073
    • Novartis Investigative Site
  • Ulm, Germany, 89077
    • Novartis Investigative Site
  • Wermsdorf, Germany, 04779
    • Novartis Investigative Site
  • Wesel, Germany, 46485
    • Novartis Investigative Site
  • Winterberg, Germany, 59955
    • Novartis Investigative Site
  • Wismar, Germany, 23966
    • Novartis Investigative Site
  • Wuppertal, Germany, 42289
    • Novartis Investigative Site
  • Würzburg, Germany, 97070
    • Novartis Investigative Site
  • Zwiesel, Germany, 94227
    • Novartis Investigative Site
  • Baden-Wurttemberg
    • Freudenstadt, Baden-Wurttemberg, Germany, 72250
      • Novartis Investigative Site
    • Heidelberg, Baden-Wurttemberg, Germany, 69115
      • Novartis Investigative Site
    • Kirchheim unter Teck, Baden-Wurttemberg, Germany, 73230
      • Novartis Investigative Site
    • Konstanz, Baden-Wurttemberg, Germany, 78464
      • Novartis Investigative Site
    • Ulm, Baden-Wurttemberg, Germany, 89073
      • Novartis Investigative Site
  • Bavaria
    • Bayreuth, Bavaria, Germany, 95445
      • Novartis Investigative Site
    • Coburg, Bavaria, Germany, 96450
      • Novartis Investigative Site
    • Dachau, Bavaria, Germany, 85221
      • Novartis Investigative Site
    • Deggendorf, Bavaria, Germany, 94469
      • Novartis Investigative Site
    • Füssen, Bavaria, Germany, 87629
      • Novartis Investigative Site
    • Grünwald, Bavaria, Germany, 82031
      • Novartis Investigative Site
    • Landshut, Bavaria, Germany, 84034
      • Novartis Investigative Site
    • Marktoberdorf, Bavaria, Germany, 87616
      • Novartis Investigative Site
    • Muehldorf Am Inn, Bavaria, Germany, 84453
      • Novartis Investigative Site
    • Munich, Bavaria, Germany, 80939
      • Novartis Investigative Site
    • Munich, Bavaria, Germany, 80331
      • Novartis Investigative Site
    • Munich, Bavaria, Germany, 81925
      • Novartis Investigative Site
    • Neumarkt in der Oberpfalz, Bavaria, Germany, 92318
      • Novartis Investigative Site
    • Nuremberg, Bavaria, Germany, 90402
      • Novartis Investigative Site
    • Würzburg, Bavaria, Germany, 97080
      • Novartis Investigative Site
  • Brandenburg
    • Burg, Brandenburg, Germany, 03096
      • Novartis Investigative Site
    • Eberswalde, Brandenburg, Germany, 16225
      • Novartis Investigative Site
    • Potsdam, Brandenburg, Germany, 14473
      • Novartis Investigative Site
    • Schwedt, Brandenburg, Germany, 16303
      • Novartis Investigative Site
  • Hesse
    • Kassel, Hesse, Germany, 34121
      • Novartis Investigative Site
    • Offenbach, Hesse, Germany, 63065
      • Novartis Investigative Site
  • Lower Saxony
    • Rotenburg (Wümme), Lower Saxony, Germany, 27356
      • Novartis Investigative Site
    • Winsen, Lower Saxony, Germany, 21423
      • Novartis Investigative Site
  • Mecklenburg-Vorpommern
    • Stralsund, Mecklenburg-Vorpommern, Germany, 18435
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Aachen, North Rhine-Westphalia, Germany, 52062
      • Novartis Investigative Site
    • Detmold, North Rhine-Westphalia, Germany, 32756
      • Novartis Investigative Site
    • Mülheim, North Rhine-Westphalia, Germany, 45468
      • Novartis Investigative Site
    • Münster, North Rhine-Westphalia, Germany, 48143
      • Novartis Investigative Site
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Novartis Investigative Site
    • Siegen, North Rhine-Westphalia, Germany, 57072
      • Novartis Investigative Site
  • Rhineland-Palatinate
    • Ingelheim, Rhineland-Palatinate, Germany, 55218
      • Novartis Investigative Site
    • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
      • Novartis Investigative Site
    • Pirmasens, Rhineland-Palatinate, Germany, 66954
      • Novartis Investigative Site
  • Saxony
    • Chemnitz, Saxony, Germany, 09113
      • Novartis Investigative Site
    • Chemnitz, Saxony, Germany, 09130
      • Novartis Investigative Site
    • Görlitz, Saxony, Germany, 02827
      • Novartis Investigative Site
    • Hohenstein-Ernstthal, Saxony, Germany, 09337
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04103
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04158
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04317
      • Novartis Investigative Site
    • Pirna, Saxony, Germany, 01796
      • Novartis Investigative Site
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • Novartis Investigative Site
    • Halle, Saxony-Anhalt, Germany, 06108
      • Novartis Investigative Site
    • Quedlinburg, Saxony-Anhalt, Germany, 06484
      • Novartis Investigative Site
    • Salzatal, Saxony-Anhalt, Germany, 06198
      • Novartis Investigative Site
    • Wittenberg, Saxony-Anhalt, Germany, 06886
      • Novartis Investigative Site
  • Thuringia
    • Greiz, Thuringia, Germany, 07973
      • Novartis Investigative Site
    • Jena, Thuringia, Germany, 07740
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Apheresis plus Inclisiran; Patients who newly initiated Inclisiran on top of lipid apheresis	Other: Inclisiran; Prospective observational cohort study. There is no treatment allocation. Patients administered Inclisiran by prescription will be enrolled.
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; Prospective observational cohort study. There is no treatment allocation. Patients administered Inclisiran by prescription will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of In- and outpatient visits	Number of In- and outpatient visits is collected	21 months
Number of examinations	Number of examinations is collected	21 months
Number and types of lipid lowering treatments	Number and types of lipid lowering treatments are collected	21 months
Number of consultations	Number of consultations beside regular visits are collected	21 months
Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time	Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time is collected for the Inclisiran Cohort.	21 months
Percentage of days covered by at least one LLT	Percentage of days covered (PDC) by at least one lipid lowering treatment (LLT) is collected	21 months
Percentage of patients with a PDC ≥ 80% months	Percentage of patients with a Percentage of days covered (PDC) ≥ 80% months is collected	21 months
Time to discontinuation of Inclisiran/ any LLT	Time to discontinuation of Inclisiran/ any lipid lowering treatment (LLT) is collected	21 months
Percentage of patients who discontinue Inclisiran/ any LLT	Percentage of patients who discontinue Inclisiran/ any lipid lowering treatment (LLT) is collected	21 months
Change in LDL-C compared to baseline	Change in Low denisty lipoprotein cholesterine (LDL-C) compared to baseline is measured	Baseline, month 3, month 9, month 15, month 21
Changes in TC, HDL-C and non-HDL-C compared to Baseline	Changes in total cholesterol (TC), High Denisty lipoprotein C (HDL-C) and non-HDL-C compared to Baseline is measured	Baseline, month 3, month 9, month 15, month 21
Change in c-reactive protein compared to baseline	Change in c-reactive protein compared to baseline is measured	Baseline, month 3, month 9, month 15, month 21
Changes in triglycerides and LP(a) compared to baseline	Changes in triglycerides and Lipoprotein (a) (LP(a)) compared to baseline are measured	Baseline, month 3, month 9, month 15, month 21
Change in hsCRP compared to Baseline	Change in high-sensitivity C-reactive protein (hs-CRP) compared to Baseline is measured	Baseline, month 3, month 9, month 15, month 21
Change in Creatinin compared to baseline	Change in Creatinin compared to baseline is measured	Baseline, month 3, month 9, month 15, month 21
Change in HbA1c compared to baseline	Change in Glycated hemoglobin (HbA1c) compared to baseline is measured	Baseline, month 3, month 9, month 15, month 21
Change in eGFR compared to baseline	Change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline is measured	Baseline, month 3, month 9, month 15, month 21
Proportion of patients achieving prespecified LDL-C targets	Proportion of patients achieving prespecified LDL-C targets based on 2019 ESC/EAS guideline for the management of dyslipidemia is collected	Baseline, month 3, month 9, month 15, month 21
Percentage of patients achieving ≥50% LDL-C reduction over time	Percentage of patients achieving ≥50% LDL-C reduction over time is collected	Baseline, month 3, month 9, month 15, month 21
Changes in SMART-Risk Scores over time compared to baseline	The SMART Risk Score is a tool to estimate 10-year risk for recurrent vascular events in patients with manifest cardiovascular disease. SMART Risk Score ranges from 0 - 100 %, where higher values indicate higher cv risk.	Baseline, month 3, month 9, month 15, month 21
Proportion of patients with treatment modifications	Proportion of patients with the following treatment modifications, is collected: dose changes; switching of lipid lowering treatment; initiation of lipid apheresis for LDL-C	21 months
Changes from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time	Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher numbers indicate better QoL.	Baseline, month 3, month 9, month 15, month 21
Changes from baseline in TSQM-9 over time	Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9) domain scores range from 0 -100, with higher scores representing higher satisfaction on that domain.	Baseline, month 3, month 9, month 15, month 21
Evaluate nutritional factors via questionnaire	Questionnaire from the German "Nationale Verzehrstudie II -Was esse ich" is used. No score is used for the interpretation. Questions about nutrition and activities are interpreted separately and compared over time.	Baseline, month 3, month 9, month 15, month 21
Percentage of Adverse Events and Serious Adverse Events	Percentage of Adverse Events (AEs) and Serious Adverse Events (SAEs) is collected	21 months
Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy	Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy is collected	21 months
Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis	Changes in the rate of lipid apheresis over time after Inclisiran initiation compared to the period 12 months pre-Baseline is collected.	12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21
Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline	Changes in high-sensitive C-reactive protein (hsCRP) are measured in labs. Values are interpresetd as; - less or 1.0 mg/l is normal 1.01 - 3.00 slightly high more than 3.0 mg/l is significantly elevated	Baseline, month 3, month 9, month 15, month 21
Apheresis plus Inclisiran Cohort: Changes in PTH	Apheresis plus Inclisiran Cohort: Changes in Parathyroid hormone (PTH)	Baseline, month 3, month 9, month 15, month 21

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Inclisiran; ASCVD; Atherosclerotic Cardiovascular Disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Nutritional and Metabolic Diseases; Hypercholesterolemia; Atherosclerosis; ALN-PCS
• Other Study ID Numbers: CKJX839A1DE01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO