Bempedoic Acid With Ezetiimibe in Adults with High Cholesterol or Mixed Dyslipidemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional, observational study conducted in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia who are treated with bempedoic acid, with or without the fixed-dose combination with ezetimibe. The primary goal is to describe patient characteristics and monitor adverse drug reactions and adverse events after starting bempedoic acid or the bempedoic acid/ezetimibe combination over about one year. Secondary aims include evaluating cardiovascular risk, LDL-C goal attainment and changes over time in LDL-C and inflammatory markers, as well as uric acid levels and AEs/ADRs. Data are collected in real-world clinical settings to understand safety and potential benefits outside of a controlled trial.

Why it matters

Who can join: the full rules

Patients can be enrolled, when they fulfil the following inclusion criteria:

* Written informed consent to participate.
* At least 18 years of age.
* Patients suffering from documented primary hypercholesterolemia or mixed dyslipidaemia treated or intended to be treated with bempedoic acid/ FDC with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
* For patients who are treated with bempedoic acid/FDC with ezetimibe prior to signed informed consent, initiation of bempedoic acid/FDC with ezetimibe must be within a maximum of three months prior to inclusion.
* No contraindications exist according to the SmPC of bempedoic acid/FDC with ezetimibe.
* No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
* Life expectancy \> 1 year.

No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.

Where it's running

• Hospital Mater Dei Contorno
  Belo Horizonte, Brazil Recruiting
• Hospital Felício Rocho
  Belo Horizonte, Brazil Recruiting
• Hospital Vera Cruz
  Belo Horizonte, Brazil Recruiting
• Clinica Procardio Ltda.
  Blumenau, Brazil Recruiting
• Universidade de Caxias do Sul (UCS)
  Caixias Do Sul, Brazil Recruiting
• Hospital e Maternidade Angelina Caron
  Campina Grande do Sul, Brazil Recruiting

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.