German Clinical Trials Register

Acronym/abbreviation of the study

DA VINCI

URL of the study

No Entry

Brief summary in lay language

The purpose of this study is to learn more about the treatment of high cholesterol in patients who are using lipid-modifying therapy (‘LMT’, a class of medication designed to lower cholesterol levels). Participants are being asked to take part in this study because they have used LMT within the past 12 months or are being prescribed it during the first study visit. About 6000 people are expected to participate in this study, across Europe. Relevant medical history will be collected from participants clinic notes as far back as is applicable. No information will be collected on the participant after the study visit; there is no further follow-up required once the first visit is finished. At the first visit, participants will be invited to complete a short questionnaire called the Patient Activation Measure (PAM) 13; this asks 13 questions relating to the participants health, and is confidential. The responses will not be seen or shared with the study doctor, and the participants identity will remain confidential. Completion of this questionnaire is voluntary, and participants may decline to participate in this part of the study if they wish. Participants will continue to attend their clinic appointments as normal and receive usual treatment as prescribed by their doctor. There are no tests or procedures required by this study and no additional visits. The main research question we are asking: how are EU patients requiring lipid modifying therapy managed.

Brief summary in scientific language

This study is designed to facilitate assessment of current treatment choices and lipid profiles in patients with or without established ASCVD, who have been prescribed LMT within 12 months of enrolment into the study. The broad inclusion criteria permit enrolment of patients with established CV disease (including peripheral vascular disease (PVD), ischaemic stroke (IS), and coronary disease) and high risk primary prevention cohorts such as those with diabetes, chronic kidney disease or elevated global risk; this enables description of clinical management across a broad spectrum of indications. The inclusion of patients treated in both primary and secondary care settings allows the description of treatment patterns outside a narrowly selected environment. Consideration of how treatment relates to relevant guidelines provides insight into potential unmet medical need in patients with or without established ASCVD, and at known or unrecognised risk of experiencing a new or recurrent CV event. This study will provide unique insights into contemporary treatment approaches in a diverse pan-European population. As an exploratory objective, the study will utilise the Patient Activation Measure (PAM-13) to assess patients’ level of engagement with their health and condition. The PAM-13 is a widely accepted patient reported outcome measure (PRO) developed at the University of Oregon, USA. It is validated in 22 languages across 30 countries and its use has been widely published (Hibbard et al Health Services Research 2004; Hibbard and Gilburt, The Kings Fund 2014; ). The level of patient activation (engagement), calculated by the PAM has been shown to correlate with differences in healthcare utilisation and outcomes. Patients with a low PAM score are considered to have low activation, and have poorer health outcomes and are at higher risk for costly utilisation of healthcare resources than patients with high scores. Having information on subgroups with low PAM scores may provide insight into the potential unmet need of patient education and engagement, to help support patients to improve the self-management of their prescribed treatment. • Research Question and Objectives Research Question: How are EU patients requiring lipid-modifying therapy routinely managed? Primary Objective: To estimate the proportion of subjects in EU primary and secondary care, with or without established ASCVD and receiving LMT, with LDL-C above 2016 Joint ESC Guideline-recommended levels. Secondary Objectives: To assess clinical characteristics and management of subjects in EU primary and secondary care, with or without established vascular/atherosclerotic disease and receiving LMT. • Hypothesis No formal hypothesis will be tested in this observational study • Study Design/Type Cross-sectional, observational, multicounty, multisite study. • Study Population The study population comprises subjects from primary and secondary care facilities in European countries, who have had LDL-C assessment and been prescribed LMT as part of routine clinical management, between February 2016 and December 2017. • Summary of Subject Eligibility Criteria: Inclusion: • LDL-C measurement within 14 months of enrolment, obtained independently of participation in a clinical trial • Use of any LMT (may include statin/ezetimibe/fibrate/PCSK9 inhibitor/bile acid absorption inhibitor/nicotinic acid/other) at time of enrolment, or any LMT prescribed within 12 months prior to date of enrolment, or any LMT prescribed at date of enrolment • Age ≥ 18 years at enrolment • Provided informed consent/notified according to local requirements • Expected to survive for at least 1 year after enrolment Exclusion: • Diagnosis of FH and with history of CV event • Currently receiving therapy for carcinoma (excepting squamous epithelial cell) • Known HIV positive status • Pregnant or breastfeeding at time of enrolment • Participating in an interventional clinical trial within 6 months prior to enrolment • Follow-up Not applicable