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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    2030
  • sponsor
    Novartis Pharmaceuticals
Updated on 24 October 2022
ezetimibe
hmg-coa reductase inhibitors
pcsk9

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.

Details
Condition Hypercholesterolemia
Treatment Inclisiran
Clinical Study IdentifierNCT05362903
SponsorNovartis Pharmaceuticals
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
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))

Exclusion Criteria

Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
Inclisiran 1 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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