A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination of bempedoic acid and ezetimibe.
- Who it may be relevant to
- Registry conditions: Primary Hypercholesterolaemia, Mixed Dyslipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-national, Non-interventional Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Overview
There is limited efficacy and safety data of bempedoic acid or its fixed dose combination (FDC) with ezetimibe in Asian and Latin American patients. This non-interventional study (NIS) will be conducted to characterize the risks and benefits of bempedoic acid or FDC with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.
Detailed description
The primary objective of this study is to describe patient characteristics and evaluate adverse drug reactions (ADRs) that occurred since initiation of bempedoic acid/FDC with ezetimibe and adverse events (AEs) collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe in a regular clinical care setting in patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia during 1-year follow-up.
The secondary objectives are defined as the assessment of the cardiovascular risk, rate, level of LDL-C goal attainment, changes over time in LDL-C levels, inflammatory markers, and uric acid levels from prior to treatment with bempedoic acid/FDC, and adverse events (AEs)/adverse drug reactions (ADRs).
Interventions
- Drug Combination of bempedoic acid and ezetimibe
No drug was administered in this observational study.
Primary outcome measures
- Incidence of adverse events [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
Secondary outcome measures (10)
- Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe using 2019 ESC/EAS guidelines risk classification [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Proportion of patients with level of LDL-C goal attainment [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Change from baseline in LDL-C levels [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Change from baseline in plasma levels of other potentially ASCVD-modifying cholesterol fragments [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Change from baseline in the levels of inflammatory marker hsCRP [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Change from baseline in uric acid levels [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Incidence of relevant cardiovascular events [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Adverse effects related to lipid-modifying treatments (LMTs) other than bempedoic acid/FDC with ezetimibe [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Use of lipid modifying therapies prior or concomitantly to receiving bempedoic acid/FDC with ezetimibe [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
- Treatment duration of bempedoic acid/FDC with ezetimibe [Time frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 22 centers
- Hospital Mater Dei Contorno — Belo Horizonte
- Hospital Felício Rocho — Belo Horizonte
- Hospital Vera Cruz — Belo Horizonte
- Clinica Procardio Ltda. — Blumenau
- Universidade de Caxias do Sul (UCS) — Caixias Do Sul
- Hospital e Maternidade Angelina Caron — Campina Grande do Sul
- Pontificia Universidade Catolica do Parana-(PUCPR) — Curitiba
- CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa LTDA — Joinville
- … and 14 more centers
Hong Kong · 1 center
- The University of Hong Kong, Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT07206472 · DS-ASCAHQ-BMP-HC001