AzTrials
AzTrials

HypercholesterolemiaNCT05362903

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

An observational study of Hypercholesterolemia, run by Novartis Pharmaceuticals at 121 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
Inclisiran
Type of treatment
Pill or oral medicine
How many people
1,868 participants
Where
121 sitesGermany
Study dates
28 Jan 2022to 28 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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)).

Who cannot join

  • Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
  • Inclisiran 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

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

Germany121 sites

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52062

  • Novartis Investigative Site

    Altenburg, 04600

  • Novartis Investigative Site

    Aue, 08280

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Nauheim, 61231

  • Novartis Investigative Site

    Bayreuth, Bavaria, 95445

  • Novartis Investigative Site

    Berlin, 10115

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 12489

  • Novartis Investigative Site

    Berlin, 12627

  • Novartis Investigative Site

    Biedenkopf, 35216

  • Novartis Investigative Site

    Borsdorf, 04451

  • Novartis Investigative Site

    Brilon, 59929

  • Novartis Investigative Site

    Brüel, 19412

  • Novartis Investigative Site

    Burg, Brandenburg, 03096

  • Novartis Investigative Site

    Chemnitz, Saxony, 09113

  • Novartis Investigative Site

    Chemnitz, Saxony, 09130

  • Novartis Investigative Site

    Chemnitz, 09116

  • Novartis Investigative Site

    Chemnitz, 09130

  • Novartis Investigative Site

    Cloppenburg, 49661

  • Novartis Investigative Site

    Coburg, Bavaria, 96450

  • Novartis Investigative Site

    Cologne, 50670

  • Novartis Investigative Site

    Cologne, 51105

  • Novartis Investigative Site

    Cuxhaven, 27476

  • Novartis Investigative Site

    Dachau, Bavaria, 85221

  • Novartis Investigative Site

    Dachau, 85221

  • Novartis Investigative Site

    Darmstadt, 64287

  • Novartis Investigative Site

    Deggendorf, Bavaria, 94469

  • Novartis Investigative Site

    Dessau, 06846

  • Novartis Investigative Site

    Detmold, North Rhine-Westphalia, 32756

  • Novartis Investigative Site

    Dresden, 01129

  • Novartis Investigative Site

    Eberswalde, Brandenburg, 16225

  • Novartis Investigative Site

    Ehingen, 89584

  • Novartis Investigative Site

    Ehringshausen, 35630

  • Novartis Investigative Site

    Eisfeld, 98673

  • Novartis Investigative Site

    Frechen, 50226

  • Novartis Investigative Site

    Freudenstadt, Baden-Wurttemberg, 72250

  • Novartis Investigative Site

    Fürth, 90766

  • Novartis Investigative Site

    Füssen, Bavaria, 87629

  • Novartis Investigative Site

    Görlitz, Saxony, 02827

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Greiz, Thuringia, 07973

  • Novartis Investigative Site

    Grünwald, Bavaria, 82031

  • Novartis Investigative Site

    Günzburg, 89312

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06108

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hamburg, 22087

  • Novartis Investigative Site

    Hamburg, 22459

  • Novartis Investigative Site

    Hamburg, 22607

  • Novartis Investigative Site

    Hamburg, 22769

  • Novartis Investigative Site

    Haßloch, 67454

  • Novartis Investigative Site

    Heide, 25746

  • Novartis Investigative Site

    Heidelberg, Baden-Wurttemberg, 69115

  • Novartis Investigative Site

    Hohenstein-Ernstthal, Saxony, 09337

  • Novartis Investigative Site

    Ingelheim, Rhineland-Palatinate, 55218

  • Novartis Investigative Site

    Jena, Thuringia, 07740

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655

  • Novartis Investigative Site

    Kassel, Hesse, 34121

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Kirchheim unter Teck, Baden-Wurttemberg, 73230

  • Novartis Investigative Site

    Konstanz, Baden-Wurttemberg, 78464

  • Novartis Investigative Site

    Landshut, Bavaria, 84034

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Leipzig, Saxony, 04158

  • Novartis Investigative Site

    Leipzig, Saxony, 04317

  • Novartis Investigative Site

    Ludwigshafen, 67071

  • Novartis Investigative Site

    Mainz, 55126

  • Novartis Investigative Site

    Mannheim, 68165

  • Novartis Investigative Site

    Markkleeberg, 04416

  • Novartis Investigative Site

    Marktoberdorf, Bavaria, 87616

  • Novartis Investigative Site

    Moers, 47441

  • Novartis Investigative Site

    Muehldorf Am Inn, Bavaria, 84453

  • Novartis Investigative Site

    Mülheim, North Rhine-Westphalia, 45468

  • Novartis Investigative Site

    München, 80333

  • Novartis Investigative Site

    Munich, Bavaria, 80331

  • Novartis Investigative Site

    Munich, Bavaria, 80939

  • Novartis Investigative Site

    Munich, Bavaria, 81925

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48143

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48149

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Naumburg, 06618

  • Novartis Investigative Site

    Neumarkt in der Oberpfalz, Bavaria, 92318

  • Novartis Investigative Site

    Neuruppin, 16816

  • Novartis Investigative Site

    Nuremberg, Bavaria, 90402

  • Novartis Investigative Site

    Offenbach, Hesse, 63065

  • Novartis Investigative Site

    Olpe, 57462

  • Novartis Investigative Site

    Oranienburg, 16515

  • Novartis Investigative Site

    Oschatz, 04758

  • Novartis Investigative Site

    Osnabrück, 49080

  • Novartis Investigative Site

    Osnabrück, 49088

  • Novartis Investigative Site

    Papenburg, 26871

  • Novartis Investigative Site

    Pirmasens, Rhineland-Palatinate, 66954

  • Novartis Investigative Site

    Pirna, Saxony, 01796

  • Novartis Investigative Site

    Potsdam, Brandenburg, 14473

  • Novartis Investigative Site

    Quedlinburg, Saxony-Anhalt, 06484

  • Novartis Investigative Site

    Rendsburg, 24768

  • Novartis Investigative Site

    Riesa, 01589

  • Novartis Investigative Site

    Rostock, 18107

  • Novartis Investigative Site

    Rotenburg (Wümme), Lower Saxony, 27356

  • Novartis Investigative Site

    Salzatal, Saxony-Anhalt, 06198

  • Novartis Investigative Site

    Schwandorf in Bayern, 92421

  • Novartis Investigative Site

    Schwedt, Brandenburg, 16303

  • Novartis Investigative Site

    Siegen, North Rhine-Westphalia, 57072

  • Novartis Investigative Site

    Speyer, 67346

  • Novartis Investigative Site

    Stadtlohn, 48703

  • Novartis Investigative Site

    Stralsund, Mecklenburg-Vorpommern, 18435

  • Novartis Investigative Site

    Trier, 54292

  • Novartis Investigative Site

    Ulm, Baden-Wurttemberg, 89073

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Ulm, 89077

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Wermsdorf, 04779

  • Novartis Investigative Site

    Wesel, 46485

  • Novartis Investigative Site

    Winsen, Lower Saxony, 21423

  • Novartis Investigative Site

    Winterberg, 59955

  • Novartis Investigative Site

    Wismar, 23966

  • Novartis Investigative Site

    Wittenberg, Saxony-Anhalt, 06886

  • Novartis Investigative Site

    Wuppertal, 42289

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

  • Novartis Investigative Site

    Würzburg, 97070

  • Novartis Investigative Site

    Zwiesel, 94227

Other trials in Germany

About this study

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

This was 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 were part of clinical routine and conducted independent of this study.

Being tested
Inclisiran
Keywords
Hypercholesterolemia, Inclisiran, Atherosclerotic Cardiovascular Disease, ASCVD
Medical subject headings
Hypercholesterolemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InclisiranOther

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

Study groups in NCT05362903
Study groupRoleWhat they receive
Oral LLTPatients 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
InclisiranPatients 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
Receives: Other: Inclisiran
Apheresis plus InclisiranPatients who newly initiated Inclisiran on top of lipid apheresis
Receives: Other: Inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis

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

    Measured: Baseline

  2. Number of patients with cardiovascular events

    Number of patients with cardiovascular events is collected

    Measured: Baseline

  3. Number of participants with concomitant medication in the previous 12 months

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

    Measured: Baseline

  4. Number of apheresis treatments in the previous 12 months

    Number of apheresis treatments in the previous 12 months is collected

    Measured: Baseline

  5. Lipid lowering therapy used in the previous 12 months

    Lipid lowering therapy used in the previous 12 months is collected

    Measured: Baseline

  6. Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted

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

    Measured: Baseline

  7. Low Density Lipoprotein cholesterol (LDL-C)

    Low Density Lipoprotein cholesterol (LDL-C) is collected

    Measured: Baseline

Secondary outcomes (29)

  1. Number of In- and outpatient visits

    Number of In- and outpatient visits is collected

    Measured: 21 months

  2. Number of examinations

    Number of examinations is collected

    Measured: 21 months

  3. Number and types of lipid lowering treatments

    Number and types of lipid lowering treatments are collected

    Measured: 21 months

  4. Number of consultations

    Number of consultations beside regular visits are collected

    Measured: 21 months

  5. 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.

    Measured: 21 months

  6. Percentage of days covered by at least one LLT

    Percentage of days covered (PDC) by at least one lipid lowering treatment (LLT) is collected

    Measured: 21 months

  7. Percentage of patients with a PDC ≥ 80% months

    Percentage of patients with a Percentage of days covered (PDC) ≥ 80% months is collected

    Measured: 21 months

  8. Time to discontinuation of Inclisiran/ any LLT

    Time to discontinuation of Inclisiran/ any lipid lowering treatment (LLT) is collected

    Measured: 21 months

  9. Percentage of patients who discontinue Inclisiran/ any LLT

    Percentage of patients who discontinue Inclisiran/ any lipid lowering treatment (LLT) is collected

    Measured: 21 months

  10. Change in LDL-C compared to baseline

    Change in Low denisty lipoprotein cholesterine (LDL-C) compared to baseline is measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  11. 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

    Measured: Baseline, month 3, month 9, month 15, month 21

  12. Change in c-reactive protein compared to baseline

    Change in c-reactive protein compared to baseline is measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  13. Changes in triglycerides and LP(a) compared to baseline

    Changes in triglycerides and Lipoprotein (a) (LP(a)) compared to baseline are measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  14. Change in hsCRP compared to Baseline

    Change in high-sensitivity C-reactive protein (hs-CRP) compared to Baseline is measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  15. Change in Creatinin compared to baseline

    Change in Creatinin compared to baseline is measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  16. Change in HbA1c compared to baseline

    Change in Glycated hemoglobin (HbA1c) compared to baseline is measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  17. Change in eGFR compared to baseline

    Change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline is measured

    Measured: Baseline, month 3, month 9, month 15, month 21

  18. 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

    Measured: Baseline, month 3, month 9, month 15, month 21

  19. Percentage of patients achieving ≥50% LDL-C reduction over time

    Percentage of patients achieving ≥50% LDL-C reduction over time is collected

    Measured: Baseline, month 3, month 9, month 15, month 21

  20. 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.

    Measured: Baseline, month 3, month 9, month 15, month 21

  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

    Measured: 21 months

  22. 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.

    Measured: Baseline, month 3, month 9, month 15, month 21

  23. 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.

    Measured: Baseline, month 3, month 9, month 15, month 21

  24. 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.

    Measured: Baseline, month 3, month 9, month 15, month 21

  25. Percentage of Adverse Events and Serious Adverse Events

    Percentage of Adverse Events (AEs) and Serious Adverse Events (SAEs) is collected

    Measured: 21 months

  26. 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

    Measured: 21 months

  27. 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.

    Measured: 12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21

  28. 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

    Measured: Baseline, month 3, month 9, month 15, month 21

  29. Apheresis plus Inclisiran Cohort: Changes in PTH

    Apheresis plus Inclisiran Cohort: Changes in Parathyroid hormone (PTH)

    Measured: Baseline, month 3, month 9, month 15, month 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start28 Jan 2022
  3. Primary completion28 Nov 2025
  4. Study completion28 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,868 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362903
Sponsor's protocol ID
CKJX839A1DE01
Status last verified
Apr 2026
First submitted
27 Apr 2022
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolemia, run by Novartis Pharmaceuticals at 121 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05362903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05362903 | AzTrials