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NCT03110432Completed

Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

Source: ClinicalTrials.gov · Last updated 9 May 2025

Brief summary (registry, in English)

This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.

Status (registry)
Completed
Study type
Observational
Enrollment
1695 (actual)
First submitted
31 Mar 2017
Start date
18 May 2017
Primary completion date
17 Apr 2024
Lead sponsor
GWT-TUD GmbH
NCT number
NCT03110432

What you commit to

  • Study type: Observational
  • Participants enrolled: 1695
  • From 18 May 2017 to the primary completion date, 17 Apr 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation of the patient in a clinical randomised study.

Who the study is looking for

  • • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or
    • with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or
    • with heterozygous familial or non- familial hypercholesterolemia or mixed dyslipidemia with
    • therapy refractory course
    • maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period
    • unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis)
    • confirmed vascular disease
    • other risk factors for cardiovascular events

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Klinik und Poliklinik für Kardiologie, Universitätsklinikum
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status
Nephrologisches Zentrum
Coordinator of this site? Confirm its status
Villingen-SchwenningenGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.