A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting - Trial NCT05362903
Access comprehensive clinical trial information for NCT05362903 through Pure Global AI's free database. This phase not specified trial is sponsored by Novartis Pharmaceuticals and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 2030 participants.
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Study Focus
Sponsor & Location
Novartis Pharmaceuticals
Novartis
Timeline & Enrollment
N/A
Jan 28, 2022
Jan 31, 2025
Primary Outcome
Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis,Number of patients with cardiovascular events,Number of participants with concomitant medication in the previous 12 months,Number of apheresis treatments in the previous 12 months,Lipid lowering therapy used in the previous 12 months,Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted,Low Density Lipoprotein cholesterol (LDL-C)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05362903
Non-Device Trial