MedPath

Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events

Completed
Conditions
Dyslipidemia
Cardiovascular Diseases
Hypercholesterolemia
Atherosclerotic Cardiovascular Disease
Registration Number
NCT04271280
Lead Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Brief Summary

High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

Detailed Description

Suffering from hypercholesterolemia is a major health concern in Europe. Appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. Despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. As this is a non-interventional study, only data from routine clinical practice will be documented.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9559
Inclusion Criteria
  • Very High Risk and High Risk dyslipidemic patients requiring LMTs
  • Not simultaneously participating in any interventional study
  • Providing written informed consent for participation in the study (Informed consent form)
  • Life expectancy > 1 year
Exclusion Criteria
  • Not applicable; non-interventional study

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular ParticipantsBaseline up to 12 months post-enrollment

Blood plasma samples were used to assess LDL-C levels.

Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)Baseline up to 12 months post-enrollment

Clinical events were assessed based on information captured in patient files/medical records.

Secondary Outcome Measures
NameTimeMethod
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic ParticipantsBaseline up to 12 months post-enrollment

Blood plasma samples were used to assess Apolipoprotein B levels.

Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic ParticipantsBaseline up to 12 months post-enrollment

Blood plasma samples were used to assess lipid Protein A levels.

Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic ParticipantsBaseline up to 12 months post-enrollment

Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels.

Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMTBaseline up to 12 months post-enrollment

The safety outcome measure reports clinical events based on information captured in patient files/medical records. Participants may have reported more than one clinical event associated with any LMT.

Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic ParticipantsBaseline up to 12 months post-enrollment

Blood plasma samples were used to assess hsCRP levels.

Trial Locations

Locations (517)

Krankenhaus St. Josef Braunau GmbH

🇦🇹

Braunau Am Inn, Austria

LKH-Univ. Klinikum Graz

🇦🇹

Graz, Austria

Medizinische Universität Graz

🇦🇹

Graz, Austria

Medizinische Universität Innsbruck

🇦🇹

Innsbruck, Austria

KABEG Klinikum Klagenfurt am Wörthersee

🇦🇹

Klagenfurt, Austria

Konventhospital der Barmherzigen Brüder Linz

🇦🇹

Linz, Austria

Privatklinik Wehrle-Diakonissen

🇦🇹

Salzburg, Austria

Ordination Universitätsdozent Dr. Alexander Kober

🇦🇹

Sankt Aegyd Am Neuwalde, Austria

Ordination Dr. med. univ. Evelyn Fließer-Görzer

🇦🇹

Sankt Stefan, Austria

Ordination Dr. Thomas Maca / Evangelische KH Wien

🇦🇹

Wien, Austria

Scroll for more (507 remaining)
Krankenhaus St. Josef Braunau GmbH
🇦🇹Braunau Am Inn, Austria

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.