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NCT05362903

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)
Novartis Pharmaceuticals·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hypercholesterolemia
Drug/Device/Intervention
Inclisiran
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Novartis Pharmaceuticals
Funder
Novartis
Location
Freudenstadt,Kirchheim,Konstanz,Coburg,Muenchen,Muenchen,Wuerzburg,Burg,Potsdam,Stralsund,Stralsund,Muenster,Kaiserslautern,Chemnitz,Eberswalde,Gorlitz,Leipzig,Pirna,Siegen,Aachen,Augsburg,Augsburg,Be, Germany
Timeline & enrollment
Phase
N/A
Start date
Jan 28, 2022
End date
Jan 31, 2025
Enrollment
2030 participants
Primary outcome

Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis,Number of patients with cardiovascular events,Number of participants with concomitant medication in the previous 12 months,Number of apheresis treatments in the previous 12 months,Lipid lowering therapy used in the previous 12 months,Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted,Low Density Lipoprotein cholesterol (LDL-C)

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.

ICD-10 classifications
Pure hypercholesterolaemiaLipoprotein deficiencyHyperglycaemia, unspecifiedDisorders of lipoprotein metabolism and other lipidaemiasOther disorders of lipoprotein metabolism
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05362903
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05362903 through Pure Global AI's free database. This phase not specified trial is sponsored by Novartis Pharmaceuticals and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 2030 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.