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Идёт набор NCT07206472

A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia

— Наблюдательное Primary Hypercholesterolaemia Mixed Dyslipidemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Combination of bempedoic acid and ezetimibe.
Кому может быть актуально
Состояния в реестре: Primary Hypercholesterolaemia, Mixed Dyslipidemia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия, Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Препарат Combination of bempedoic acid and ezetimibe
    No drug was administered in this observational study.

Первичные конечные точки

  • Incidence of adverse events [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
Вторичные конечные точки (10)
  • Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe using 2019 ESC/EAS guidelines risk classification [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
  • Proportion of patients with level of LDL-C goal attainment [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
  • Change from baseline in LDL-C levels [Срок оценки: 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 [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
  • Change from baseline in the levels of inflammatory marker hsCRP [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
  • Change from baseline in uric acid levels [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
  • Incidence of relevant cardiovascular events [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]
  • Treatment duration of bempedoic acid/FDC with ezetimibe [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бразилия · 22 центра
  • 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
  • … и ещё 14 центров
Гонконг · 1 центр
  • The University of Hong Kong, Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT07206472 · DS-ASCAHQ-BMP-HC001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗