Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal Study (SANTORINI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,559
- 试验地点
- 517
- 主要终点
- Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not applicable; non-interventional study
结局指标
主要结局
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
时间窗: 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)
时间窗: Baseline up to 12 months post-enrollment
Clinical events were assessed based on information captured in patient files/medical records.
次要结局
- Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants(Baseline up to 12 months post-enrollment)
- Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants(Baseline up to 12 months post-enrollment)
- 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)
- Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT(Baseline up to 12 months post-enrollment)
- Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants(Baseline up to 12 months post-enrollment)