Status:
ACTIVE_NOT_RECRUITING
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Primary Hypercholesterolemia
Mixed Dyslipidemia
Eligibility:
All Genders
18-100 years
Brief Summary
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditio...
Detailed Description
Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.
Eligibility Criteria
Inclusion
- Participants who are 18 years or older
- Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
- Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
- Participants who per physician's criteria need to optimize their LLT
- Participants who provide written informed consent to participate in the study
- Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.
Exclusion
- Participants that have received inclisiran previously
- Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)
Key Trial Info
Start Date :
September 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 5 2026
Estimated Enrollment :
852 Patients enrolled
Trial Details
Trial ID
NCT05399992
Start Date
September 12 2022
End Date
October 5 2026
Last Update
December 9 2025
Active Locations (40)
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1
Novartis Investigative Site
Feldkirch, Austria, 6807
2
Novartis Investigative Site
Graz, Austria, 8036
3
Novartis Investigative Site
Linz, Austria, 4021
4
Novartis Investigative Site
Sankt Veit im Pongau, Austria, 5621