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Active Not Recruiting
NCT05399992
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Conditions: Primary Hypercholesterolemia, Mixed Dyslipidemia
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 847
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Feldkirch
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 conditions of routine clinical practice.
Eligibility Criteria
Inclusion Criteria:
1. Participants who are 18 years or older
2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
4. Participants who per physician's criteria need to optimize their LLT
5. Participants who provide written informed consent to participate in the study
6. 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 Criteria:
1. Participants that have received inclisiran previously
2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)
Source: ClinicalTrials.gov (NCT05399992). StuddyBuddy aggregates publicly available trial information.