German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

Hypercholesterolemia Clinical Trial

— GIN  

Official title:

German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438069
• Other study ID #: 2021-2429
• Status: Recruiting
• Start date: December 11, 2020
• Est. completion date: December 11, 2025

Study information

• Verified date: July 2022
• Source: Jena University Hospital
• Contact: Oliver Weingaertner, MD
• Phone: +4936419324521
• Email: oliver.weingaertner[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

Description:

The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 11, 2025
• Est. primary completion date: December 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran

• patients 18 years and older

Exclusion Criteria:

• patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena

Sponsors (9)

Lead Sponsor	Collaborator
Jena University Hospital	Charite University, Berlin, Germany, Deutsches Herzzentrum Muenchen, LMU Klinikum, Ruhr University of Bochum, Technische Universität Dresden, Universitätsklinikum Leipzig, Universitätsmedizin Mannheim, University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C change	LDL-C change in mg/dL / mmol/L	3 months, 6 months, 12 months, 24 months