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NCT Number: NCT04271280

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

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.

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Key information

Conditions

Dyslipidemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus St. Josef Braunau GmbH, Braunau am Inn, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

This is a non-interventional study.

Primary outcomes

  1. Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants

    Time frame: Baseline up to 12 months post-enrollment

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

  2. 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)

    Time frame: Baseline up to 12 months post-enrollment

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

Secondary outcomes

  1. Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants

    Time frame: Baseline up to 12 months post-enrollment

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

  2. Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants

    Time frame: Baseline up to 12 months post-enrollment

    Blood plasma samples were used to assess Apolipoprotein B levels.

  3. Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants

    Time frame: Baseline up to 12 months post-enrollment

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

  4. Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants

    Time frame: Baseline up to 12 months post-enrollment

    Blood plasma samples were used to assess hsCRP levels.

  5. Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Industry

Registry information

Official study title

Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal Study (SANTORINI)

Acronym: SANTORINI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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