VICTORION REAL: An International Prospective Real-world Study to Evaluate the Effectiveness and Adherence of Inclisiran Plus Standard of Care Lipid-lowering Therapy Compared to Standard of Care Therapy Alone in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (VICTORION REAL)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2027
  • participants needed
    2100
  • sponsor
    Novartis Pharmaceuticals
Updated on 18 October 2022

Summary

This observational matched prospective study aims to assess the effectiveness and adherence for inclisiran in combination with Lipid lowering therapies or Lipid lowering treatments (LLT) compared to other LLTs under conditions of routine clinical practice.

Description

Patients will be enrolled over a period of 24 months, and followed for up to 36 months to assess for study outcomes.

Details
Condition Primary Hypercholesterolemia, Mixed Dyslipidemia
Treatment Inclisiran
Clinical Study IdentifierNCT05399992
SponsorNovartis Pharmaceuticals
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who are 18 years or older
Patients with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
Patients who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
Patients who per physician's criteria need to optimize their LLT
Patients who provide written informed consent to participate in the study
Cohort-specific
Inclisiran Cohort
Patients who initiate inclisiran under conditions per local label
SoC Cohort - Patients who initiate a LLT therapy other than inclisiran, or
patients who have existing LLT switched or modified (dosage) no more than 4
months after the Index Date for their matched Inclisiran Cohort patient, and
anytime during the 24 month enrollment period. Eligible LLT's include statins
ezetimibe, PCSK9 inhibitors (alirocumab, evolocumab), fibrates, bempedoic acid
or bile acid sequestrants

Exclusion Criteria

Patients that have received inclisiran previously
Patients participating in a clinical trial with investigational product
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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