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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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05362903
Collaborator
(none)
2,030
Enrollment
36
Locations
36.1
Anticipated Duration (Months)
56.4
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Inclisiran

Study Design

Study Type:
Observational
Anticipated Enrollment :
2030 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Jan 28, 2022
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Oral LLT

Patients who newly initiated oral Lipid lowering treatment (LLT) on top of a statin
Inclisiran

Patients who newly initiated Inclisiran Inclisiran in a PCSK9-treatment naive cohort 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.
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.

Outcome Measures

Primary Outcome Measures

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

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

  2. Number of patients with cardiovascular events [Baseline]

    Number of patients with cardiovascular events is collected

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

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

  4. Number of apheresis treatments in the previous 12 months [Baseline]

    Number of apheresis treatments in the previous 12 months is collected

  5. Lipid lowering therapy used in the previous 12 months [Baseline]

    Lipid lowering therapy used in the previous 12 months is collected

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

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

  7. Low Density Lipoprotein cholesterol (LDL-C) [Baseline]

    Low Density Lipoprotein cholesterol (LDL-C) is collected

Secondary Outcome Measures

  1. Number of In- and outpatient visits [21 months]

    Number of In- and outpatient visits is collected

  2. Number of examinations [21 months]

    Number of examinations is collected

  3. Number and types of lipid lowering treatments [21 months]

    Number and types of lipid lowering treatments are collected

  4. Number of consultations [21 months]

    Number of consultations beside regular visits are collected

  5. Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time [21 months]

    Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time is collected for the Inclisiran Cohort.

  6. Percentage of days covered by at least one LLT [21 months]

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

  7. Percentage of patients with a PDC ≥ 80% months [21 months]

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

  8. Time to discontinuation of Inclisiran/ any LLT [21 months]

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

  9. Percentage of patients who discontinue Inclisiran/ any LLT [21 months]

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

  10. Change in LDL-C compared to baseline [Baseline, month 3, month 9, month 15, month 21]

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

  11. Changes in TC, HDL-C and non-HDL-C compared to Baseline [Baseline, month 3, month 9, month 15, month 21]

    Changes in total cholesterol (TC), High Denisty lipoprotein C (HDL-C) and non-HDL-C compared to Baseline is measured

  12. Change in c-reactive protein compared to baseline [Baseline, month 3, month 9, month 15, month 21]

    Change in c-reactive protein compared to baseline is measured

  13. Changes in triglycerides and LP(a) compared to baseline [Baseline, month 3, month 9, month 15, month 21]

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

  14. Change in hsCRP compared to Baseline [Baseline, month 3, month 9, month 15, month 21]

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

  15. Change in Creatinin compared to baseline [Baseline, month 3, month 9, month 15, month 21]

    Change in Creatinin compared to baseline is measured

  16. Change in HbA1c compared to baseline [Baseline, month 3, month 9, month 15, month 21]

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

  17. Change in eGFR compared to baseline [Baseline, month 3, month 9, month 15, month 21]

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

  18. Proportion of patients achieving prespecified LDL-C targets [Baseline, month 3, month 9, month 15, month 21]

    Proportion of patients achieving prespecified LDL-C targets based on 2019 ESC/EAS guideline for the management of dyslipidemia is collected

  19. Percentage of patients achieving ≥50% LDL-C reduction over time [Baseline, month 3, month 9, month 15, month 21]

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

  20. Changes in SMART-Risk Scores over time compared to baseline [Baseline, month 3, month 9, month 15, month 21]

    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.

  21. Proportion of patients with treatment modifications [21 months]

    Proportion of patients with the following treatment modifications, is collected: dose changes switching of lipid lowering treatment initiation of lipid apheresis for LDL-C

  22. Changes from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time [Baseline, month 3, month 9, month 15, month 21]

    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.

  23. Changes from baseline in TSQM-9 over time [Baseline, month 3, month 9, month 15, month 21]

    Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9) domain scores range from 0 -100, with higher scores representing higher satisfaction on that domain.

  24. Evaluate nutritional factors via questionnaire [Baseline, month 3, month 9, month 15, month 21]

    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.

  25. Percentage of Adverse Events and Serious Adverse Events [21 months]

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

  26. Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy [21 months]

    Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy is collected

  27. Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis [12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21]

    Changes in the rate of lipid apheresis over time after Inclisiran initiation compared to the period 12 months pre-Baseline is collected.

  28. Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline [Baseline, month 3, month 9, month 15, month 21]

    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

  29. Apheresis plus Inclisiran Cohort: Changes in PTH [Baseline, month 3, month 9, month 15, month 21]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Freudenstadt Baden Wuerttemberg Germany 72250
2 Novartis Investigative Site Konstanz Baden-Wuerttemberg Germany 78464
3 Novartis Investigative Site Muenchen Bavaria Germany
4 Novartis Investigative Site Stralsund Mecklenburg Vorpommern Germany 18435
5 Novartis Investigative Site Stralsund Mecklenburg-Vorpommern Germany
6 Novartis Investigative Site Kaiserslautern Rhineland-Palatinate Germany 67655
7 Novartis Investigative Site Eberswalde Saxony Germany 16225
8 Novartis Investigative Site Leipzig Saxony Germany 04317
9 Novartis Investigative Site Pirna Saxony Germany 01796
10 Novartis Investigative Site Berlin Germany 10789
11 Novartis Investigative Site Berlin Germany
12 Novartis Investigative Site Chemnitz Germany 09116
13 Novartis Investigative Site Chemnitz Germany 09130
14 Novartis Investigative Site Cologne Germany 51105
15 Novartis Investigative Site Dresden Germany 01307
16 Novartis Investigative Site Halle Saale Germany 06120
17 Novartis Investigative Site Hamburg Germany 22459
18 Novartis Investigative Site Koeln Germany
19 Novartis Investigative Site Leipzig Germany 04103
20 Novartis Investigative Site Lüneburg Germany 21339
21 Novartis Investigative Site Mannheim Germany 68165
22 Novartis Investigative Site Markkleeberg Germany 04416
23 Novartis Investigative Site Moers Germany 47441
24 Novartis Investigative Site Morsbach Germany 51597
25 Novartis Investigative Site Muenster Germany 48149
26 Novartis Investigative Site Münster Germany 48143
27 Novartis Investigative Site Offenbach Germany 63065
28 Novartis Investigative Site Oschatz Germany 04758
29 Novartis Investigative Site Papenburg Germany 26871
30 Novartis Investigative Site Pirmasens Germany D-66954
31 Novartis Investigative Site Riesa Germany 01589
32 Novartis Investigative Site Rostock Germany 18107
33 Novartis Investigative Site Salzatal Germany D-06198
34 Novartis Investigative Site Ulm Germany 89073
35 Novartis Investigative Site Wermsdorf Germany 04779
36 Novartis Investigative Site Wesel Germany 46485

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05362903
Other Study ID Numbers:
  • CKJX839A1DE01
First Posted:
May 5, 2022
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Novartis Pharmaceuticals
Hypercholesterolemia
Inclisiran
Atherosclerotic Cardiovascular Disease
ASCVD
Additional relevant MeSH terms:
Hypercholesterolemia

Study Results

No Results Posted as of May 11, 2022