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

Study Overview
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Brief Summary
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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
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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 from the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in unexpected events like side effects or increase in diabetes. No study intervention will be provided for administration for this study.

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

Conditions
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Dyslipidemic, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Very High Risk and High Risk 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 observational study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Risk and Very High Risk Dyslipidemic Participants<br>Participants are stratified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants and ) as well as if previously or newly diagnosed. | Other: Non-interventional<br>* This is a non-interventional, observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants |  | Baseline up to 12 months post-enrollment | 
| Change from Baseline in the Utilization of Treatment Modalities in Managing 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-risk dyslipidemic, Low-density lipoprotein cholesterol, Cardiovascular disease, Lipid modifying therapies, Dyslipidemic, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease