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

Hypercholesterolemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362903
• Other study ID #: CKJX839A1DE01
• Status: Recruiting
• Start date: January 28, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2030
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Altenburg
Germany	Novartis Investigative Site	Aue
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bad Nauheim
Germany	Novartis Investigative Site	Bad Salzuflen	Northrhine Westfalia
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Biedenkopf
Germany	Novartis Investigative Site	Borsdorf
Germany	Novartis Investigative Site	Brilon
Germany	Novartis Investigative Site	Brueel
Germany	Novartis Investigative Site	Burg	Brandenburg
Germany	Novartis Investigative Site	Chemnitz	Saxony
Germany	Novartis Investigative Site	Chemnitz	Saxonia
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Cloppenburg
Germany	Novartis Investigative Site	Coburg	Bavaria
Germany	Novartis Investigative Site	Cologne
Germany	Novartis Investigative Site	Dachau
Germany	Novartis Investigative Site	Dachau
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Deggendorf	Bavaria
Germany	Novartis Investigative Site	Dessau-Roßlau
Germany	Novartis Investigative Site	Detmold	NRW
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Eberswalde	Saxony
Germany	Novartis Investigative Site	Ehingen
Germany	Novartis Investigative Site	Ehringshausen
Germany	Novartis Investigative Site	Eisfeld
Germany	Novartis Investigative Site	Emmendingen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Freudenstadt	Baden Wuerttemberg
Germany	Novartis Investigative Site	Fuerth
Germany	Novartis Investigative Site	Fussen
Germany	Novartis Investigative Site	Gorlitz	Saxony
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Greiz
Germany	Novartis Investigative Site	Greiz	Thueringen
Germany	Novartis Investigative Site	Gruenwald
Germany	Novartis Investigative Site	Guenzburg
Germany	Novartis Investigative Site	Hachenburg
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Halle Saale
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hassloch
Germany	Novartis Investigative Site	Heide
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Hohenstein-Ernstthal
Germany	Novartis Investigative Site	Ingelheim
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kaiserslautern	Rhineland-Palatinate
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Kirchheim	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Königsbrück
Germany	Novartis Investigative Site	Konstanz	Baden Wuerttemberg
Germany	Novartis Investigative Site	Landshut	Bavaria
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig	Saxony
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Lüneburg
Germany	Novartis Investigative Site	Lutherstadt Wittenberg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Markkleeberg
Germany	Novartis Investigative Site	Marktoberdorf	Bavaria
Germany	Novartis Investigative Site	Moers
Germany	Novartis Investigative Site	Morsbach
Germany	Novartis Investigative Site	Muehldorf
Germany	Novartis Investigative Site	Muehlheim An Der Ruhr
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen	Bavaria
Germany	Novartis Investigative Site	Muenchen	Bavaria
Germany	Novartis Investigative Site	Muenster	Northrhine Westfalia
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Naumburg
Germany	Novartis Investigative Site	Neumarkt
Germany	Novartis Investigative Site	Neuruppin
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Offenbach
Germany	Novartis Investigative Site	Olpe
Germany	Novartis Investigative Site	Oranienburg
Germany	Novartis Investigative Site	Oschatz
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Papenburg
Germany	Novartis Investigative Site	Passau
Germany	Novartis Investigative Site	Pirmasens
Germany	Novartis Investigative Site	Pirna	Saxony
Germany	Novartis Investigative Site	Potsdam	Brandenburg
Germany	Novartis Investigative Site	Quedlinburg	Saxony Anhalt
Germany	Novartis Investigative Site	Rendsburg
Germany	Novartis Investigative Site	Riesa
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rotenburg	Lower Saxony
Germany	Novartis Investigative Site	Salzatal
Germany	Novartis Investigative Site	Schwedt
Germany	Novartis Investigative Site	Siegen	Westfalia
Germany	Novartis Investigative Site	Speyer
Germany	Novartis Investigative Site	Stadtlohn
Germany	Novartis Investigative Site	Stralsund	Mecklenburg Vorpommern
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Viersen
Germany	Novartis Investigative Site	Villingen-Schwenningen
Germany	Novartis Investigative Site	Wermsdorf
Germany	Novartis Investigative Site	Wesel
Germany	Novartis Investigative Site	Winsen	Lower Saxony
Germany	Novartis Investigative Site	Winterberg
Germany	Novartis Investigative Site	Wismar
Germany	Novartis Investigative Site	Witten	North Rhine-WestPhalia
Germany	Novartis Investigative Site	Wuerzburg	Bavaria
Germany	Novartis Investigative Site	Wuerzburg
Germany	Novartis Investigative Site	Zwenkau
Germany	Novartis Investigative Site	Zwiesel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis	Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis is collected	Baseline
Primary	Number of patients with cardiovascular events	Number of patients with cardiovascular events is collected	Baseline
Primary	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
Primary	Number of apheresis treatments in the previous 12 months	Number of apheresis treatments in the previous 12 months is collected	Baseline
Primary	Lipid lowering therapy used in the previous 12 months	Lipid lowering therapy used in the previous 12 months is collected	Baseline
Primary	Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted	Number of lipid apheresis conducted on Apheresis plus Inclisiran cohort is collected	Baseline
Primary	Low Density Lipoprotein cholesterol (LDL-C)	Low Density Lipoprotein cholesterol (LDL-C) is collected	Baseline
Secondary	Number of In- and outpatient visits	Number of In- and outpatient visits is collected	21 months
Secondary	Number of examinations	Number of examinations is collected	21 months
Secondary	Number and types of lipid lowering treatments	Number and types of lipid lowering treatments are collected	21 months
Secondary	Number of consultations	Number of consultations beside regular visits are collected	21 months
Secondary	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
Secondary	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
Secondary	Percentage of patients with a PDC = 80% months	Percentage of patients with a Percentage of days covered (PDC) = 80% months is collected	21 months
Secondary	Time to discontinuation of Inclisiran/ any LLT	Time to discontinuation of Inclisiran/ any lipid lowering treatment (LLT) is collected	21 months
Secondary	Percentage of patients who discontinue Inclisiran/ any LLT	Percentage of patients who discontinue Inclisiran/ any lipid lowering treatment (LLT) is collected	21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Creatinin compared to baseline	Change in Creatinin compared to baseline is measured	Baseline, month 3, month 9, month 15, month 21
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Adverse Events and Serious Adverse Events	Percentage of Adverse Events (AEs) and Serious Adverse Events (SAEs) is collected	21 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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