Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting

NCT05362903

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Hypercholesterolemia

Interventions: Inclisiran

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Patients who provide written informed consent to participate in the study
2. Male or female patients ≥ 18 years of age
3. 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
4. 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
5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).

Exclusion Criteria:

1. Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
2. Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
3. Contraindication for Inclisiran according to the SmPC
4. Patients who have received Inclisiran previously
5. Patients with homozygous FH
6. 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.
7. Simultaneous or planned participation in an interventional research study
Locations (121)
  • Freudenstadt, Baden-Wurttemberg, Germany
  • Heidelberg, Baden-Wurttemberg, Germany
  • Kirchheim unter Teck, Baden-Wurttemberg, Germany
  • Konstanz, Baden-Wurttemberg, Germany
  • Ulm, Baden-Wurttemberg, Germany
  • Bayreuth, Bavaria, Germany
  • Coburg, Bavaria, Germany
  • Dachau, Bavaria, Germany
  • Deggendorf, Bavaria, Germany
  • Füssen, Bavaria, Germany
  • Grünwald, Bavaria, Germany
  • Landshut, Bavaria, Germany
  • Marktoberdorf, Bavaria, Germany
  • Muehldorf Am Inn, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Neumarkt in der Oberpfalz, Bavaria, Germany
  • Nuremberg, Bavaria, Germany
  • Würzburg, Bavaria, Germany
  • Burg, Brandenburg, Germany
  • Eberswalde, Brandenburg, Germany
  • Potsdam, Brandenburg, Germany
  • Schwedt, Brandenburg, Germany
  • Kassel, Hesse, Germany
  • Offenbach, Hesse, Germany
  • Rotenburg (Wümme), Lower Saxony, Germany
  • Winsen, Lower Saxony, Germany
  • Stralsund, Mecklenburg-Vorpommern, Germany
  • Aachen, North Rhine-Westphalia, Germany
  • + 91 more on CT.gov