Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
- Conditions
- DyslipidemiaCardiovascular DiseasesHypercholesterolemiaAtherosclerotic 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
- 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
- Not applicable; non-interventional study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants Baseline 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
Name Time Method Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants Baseline 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 Participants Baseline 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 Participants Baseline 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 LMT Baseline 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 Participants Baseline 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
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