Status:
COMPLETED
A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-100 years
Brief 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 sta...
Eligibility Criteria
Inclusion
- 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) or new oral LLT alone in case of statin intolerance or contraindication
- 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
- 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
Key Trial Info
Start Date :
January 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 28 2025
Estimated Enrollment :
1871 Patients enrolled
Trial Details
Trial ID
NCT05362903
Start Date
January 28 2022
End Date
November 28 2025
Last Update
December 4 2025
Active Locations (121)
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1
Novartis Investigative Site
Freudenstadt, Baden-Wurttemberg, Germany, 72250
2
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, Germany, 69115
3
Novartis Investigative Site
Kirchheim unter Teck, Baden-Wurttemberg, Germany, 73230
4
Novartis Investigative Site
Konstanz, Baden-Wurttemberg, Germany, 78464