Registry of patients treated with inclisiran for high cholesterol in Germany
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany
This study looks at how well inclisiran works to lower cholesterol in different patients in Germany who are already being treated for high cholesterol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 1 site (Jena) |
| Trial ID | NCT05438069 on ClinicalTrials.gov |
What this trial studies
This observational study is a retrospective registry that collects data from patients with hypercholesterolemia who are being treated with the siRNA inclisiran in Germany. The study aims to analyze individual patient data to assess the variability in LDL-C reduction resulting from inclisiran treatment in a real-world clinical setting. By examining this data, researchers hope to gain insights into the effectiveness of inclisiran across different patient populations and treatment scenarios.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with elevated LDL-C levels who have been on stable lipid-lowering medications for at least one month prior to receiving inclisiran.
Not a fit: Patients who do not meet the treatment criteria for inclisiran as defined by the G-BA in Germany will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of inclisiran, potentially leading to improved treatment strategies for patients with high cholesterol.
How similar studies have performed: While this study is observational and retrospective, similar approaches in analyzing real-world data for cholesterol treatments have shown promise in understanding treatment variability and effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jena
- Jena University Hospital — Jena, Germany (Recruiting)
Study contacts
- Principal investigator: Oliver Weingaertner, MD — Jena University Hospital
- Study coordinator: Oliver Weingaertner, MD
- Email: oliver.weingaertner@med.uni-jena.de
- Phone: +4936419324521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.