Clinical trial NCT05362903: A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Inclisiran
Atherosclerotic Cardiovascular Disease
ASCVD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 2030
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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) (Oral LLT Cohort),
* Patients newly initiated with Inclisiran (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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis
timeFrame: Baseline
measure: Number of patients with cardiovascular events
timeFrame: Baseline
measure: Number of participants with concomitant medication in the previous 12 months
timeFrame: Baseline
measure: Number of apheresis treatments in the previous 12 months
timeFrame: Baseline
measure: Lipid lowering therapy used in the previous 12 months
timeFrame: Baseline
measure: Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted
timeFrame: Baseline
measure: Low Density Lipoprotein cholesterol (LDL-C)
timeFrame: Baseline
Secondary outcomes:
measure: Number of In- and outpatient visits
timeFrame: 21 months
measure: Number of examinations
timeFrame: 21 months
measure: Number and types of lipid lowering treatments
timeFrame: 21 months
measure: Number of consultations
timeFrame: 21 months
measure: Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time
timeFrame: 21 months
measure: Percentage of days covered by at least one LLT
timeFrame: 21 months
measure: Percentage of patients with a PDC ≥ 80% months
timeFrame: 21 months
measure: Time to discontinuation of Inclisiran/ any LLT
timeFrame: 21 months
measure: Percentage of patients who discontinue Inclisiran/ any LLT
timeFrame: 21 months
measure: Change in LDL-C compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Changes in TC, HDL-C and non-HDL-C compared to Baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Change in c-reactive protein compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Changes in triglycerides and LP(a) compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Change in hsCRP compared to Baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Change in Creatinin compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Change in HbA1c compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Change in eGFR compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Proportion of patients achieving prespecified LDL-C targets
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Percentage of patients achieving ≥50% LDL-C reduction over time
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Changes in SMART-Risk Scores over time compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Proportion of patients with treatment modifications
timeFrame: 21 months
measure: Changes from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Changes from baseline in TSQM-9 over time
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Evaluate nutritional factors via questionnaire
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Percentage of Adverse Events and Serious Adverse Events
timeFrame: 21 months
measure: Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy
timeFrame: 21 months
measure: Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis
timeFrame: 12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21
measure: Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21
measure: Apheresis plus Inclisiran Cohort: Changes in PTH
timeFrame: Baseline, month 3, month 9, month 15, month 21
Other outcomes:
Locations:
city: Freudenstadt
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Kirchheim Unter Teck
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Konstanz
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Coburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Deggendorf
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Marktoberdorf
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Dachau
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Fuessen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Gruenwald
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Landshut
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Burg
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Potsdam
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Kassel
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Rotenburg
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Winsen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Stralsund
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg Vorpommern
city: Aachen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bad Salzuflen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: Novartis Investigative Site
state: North Rhine-WestPhalia
city: Muenster
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Detmold
country: Germany
facility: Novartis Investigative Site
state: NRW
city: Ingelheim
country: Germany
facility: Novartis Investigative Site
state: Rheinland Pfalz
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Halle Saale
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Halle Saale
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Eberswalde
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Goerlitz
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Hohenstein-Ernstthal
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
state: Saxonia
city: Quedlinburg
country: Germany
facility: Novartis Investigative Site
state: Saxony Anhalt
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
state: Saxony
city: Pirna
country: Germany
facility: Novartis Investigative Site
state: Saxony
city: Greiz
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Greiz
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Siegen
country: Germany
facility: Novartis Investigative Site
state: Westfalia
city: Altenburg
country: Germany
facility: Novartis Investigative Site
city: Altenburg
country: Germany
facility: Novartis Investigative Site
city: Aue
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Homburg
country: Germany
facility: Novartis Investigative Site
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Biedenkopf
country: Germany
facility: Novartis Investigative Site
city: Borsdorf
country: Germany
facility: Novartis Investigative Site
city: Brilon
country: Germany
facility: Novartis Investigative Site
city: Brueel
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Cloppenburg
country: Germany
facility: Novartis Investigative Site
city: Cuxhaven
country: Germany
facility: Novartis Investigative Site
city: Dachau
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Dessau-Rosslau
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Ehingen
country: Germany
facility: Novartis Investigative Site
city: Ehringshausen
country: Germany
facility: Novartis Investigative Site
city: Eisfeld
country: Germany
facility: Novartis Investigative Site
city: Emmendingen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frechen
country: Germany
facility: Novartis Investigative Site
city: Fuerth
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Guenzburg
country: Germany
facility: Novartis Investigative Site
city: Hachenburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hassloch
country: Germany
facility: Novartis Investigative Site
city: Heide
country: Germany
facility: Novartis Investigative Site
city: Hennigsdorf
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koenigsbrueck
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
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country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Markkleeberg
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Morsbach
country: Germany
facility: Novartis Investigative Site
city: Muehldorf
country: Germany
facility: Novartis Investigative Site
city: Muehlheim An Der Ruhr
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munster
country: Germany
facility: Novartis Investigative Site
city: Naumburg
country: Germany
facility: Novartis Investigative Site
city: Neumarkt
country: Germany
facility: Novartis Investigative Site
city: Neuruppin
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Offenbach
country: Germany
facility: Novartis Investigative Site
city: Olpe
country: Germany
facility: Novartis Investigative Site
city: Oranienburg
country: Germany
facility: Novartis Investigative Site
city: Oschatz
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Passau
country: Germany
facility: Novartis Investigative Site
city: Pirmasens
country: Germany
facility: Novartis Investigative Site
city: Rendsburg
country: Germany
facility: Novartis Investigative Site
city: Riesa
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Salzatal
country: Germany
facility: Novartis Investigative Site
city: Schwandorf
country: Germany
facility: Novartis Investigative Site
city: Schwedt
country: Germany
facility: Novartis Investigative Site
city: Speyer
country: Germany
facility: Novartis Investigative Site
city: Stadtlohn
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Viersen
country: Germany
facility: Novartis Investigative Site
city: Villingen-Schwenningen
country: Germany
facility: Novartis Investigative Site
city: Wermsdorf
country: Germany
facility: Novartis Investigative Site
city: Wesel
country: Germany
facility: Novartis Investigative Site
city: Winterberg
country: Germany
facility: Novartis Investigative Site
city: Wismar
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Zwenkau
country: Germany
facility: Novartis Investigative Site
city: Zwiesel
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: