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

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

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolemia

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Oliver Weingaertner, MD; Phone Number: +4936419324521; Email: oliver.weingaertner@med.uni-jena.de
• Study Contact Backup: Name: Martin Foerster, PhD; Phone Number: +4936419325818; Email: Martin.Foerster@med.uni-jena.de

Study Locations

• Germany
  • Jena, Germany
    • Recruiting
    • Jena University Hospital
    • Sub-Investigator: Umidakhon Makhmudova, MD
    • Contact: Martin Foerster, PhD; Phone Number: +4936419325818; Email: Martin.Foerster@med.uni-jena.de
    • Contact: Oliver Weingärtner, MD; Phone Number: +4936419324521; Email: oliver.weingaertner@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

-patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with elevated LDL-cholesterol (hypercholesterolemia); Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C change	LDL-C change in mg/dL / mmol/L	3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Charite University, Berlin, Germany; Ruhr University of Bochum; Technische Universität Dresden; LMU Klinikum; Deutsches Herzzentrum Muenchen; University of Rostock; Universitätsmedizin Mannheim; Universitätsklinikum Leipzig
• Investigators: Principal Investigator: Oliver Weingaertner, MD, Jena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Anticipated): December 11, 2025
• Study Completion (Anticipated): December 11, 2025

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 2021-2429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Data that will be shared:

Study protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.

• IPD Sharing Time Frame: 3 months after publication for 3 years

IPD Sharing Access Criteria

Data that will be shared:

Study protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No