A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or 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: Bempedoic acid, Ezetimibe, Rosuvastatin, Atorvastatin.
- Кому может быть актуально
- Состояния в реестре: Primary Hypercholesterolemiia, 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
- Австрия, Бельгия, Германия, Италия, Испания
- 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
Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study
Обзор
Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.
Подробное описание
The aim of the current study is to evaluate the effectiveness and safety of bempedoic acid combined with ezetimibe and either atorvastatin or rosuvastatin (hereafter defined as triple therapy) in a real-world clinical setting. No drug will be administered during this observational study.
The primary objective of the study is to evaluate the effectiveness of the triple therapy in terms of LDL-C reduction at 8 weeks.
The secondary objectives will include the following:
* Goal attainment at 8 weeks and 1 year after start of triple therapy * Effectiveness of triple therapy in terms of LDL-C reduction at 1 year * Effectiveness of adding bempedoic acid to statin and ezetimbe at 8 weeks and 1 year * Effectiveness of adding bempedoic acid/ezetimibe FDC to statin in terms of LDL-C reduction at 8 weeks and 1 year * Changes in laboratory values at 8 weeks and 1 year after start of triple therapy * Adherence to triple therapy treatment * Collection and recording of all adverse events occurred since initiation of triple therapy * MACE-3 and MACE-4 (consisting of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only)) during the year of follow-up * Treatment changes at LMT initiation and at triple therapy initiation * Treatment pathway from triple therapy initiation to 1-year after start of triple therapy
Вмешательства
- Препарат Bempedoic acid
No drug was administered in this observational study. - Препарат Ezetimibe
No drug was administered in this observational study. - Препарат Rosuvastatin
No drug was administered in this observational study. - Препарат Atorvastatin
No drug was administered in this observational study.
Первичные конечные точки
- Relative LDL-C change between untreated and 8 week after triple therapy start [Срок оценки: Baseline to 8 weeks after initiation of triple therapy]
Вторичные конечные точки (8)
- Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year [Срок оценки: Baseline to 1 year after initiation of triple therapy]
- Relative LDL-C change between untreated and 1 year after triple therapy start [Срок оценки: From any prior LMT exposure to 1 year after initiation of triple therapy]
- Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 8 weeks after triple therapy start [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy]
- Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 1 year after triple therapy start [Срок оценки: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy]
- Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter [Срок оценки: Baseline to 1 year after initiation of triple therapy]
- Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start [Срок оценки: Baseline to 1 year after initiation of triple therapy]
- Incidence of adverse events under triple therapy exposure [Срок оценки: Baseline to 1 year after initiation of triple therapy]
- Proportion of patients with MACE-3 and MACE-4 events [Срок оценки: Baseline to 1 year after initiation of triple therapy]
Критерии участия
Критерии включения
- Written informed consent to participate
- At least 18 years of age
- High and very high risk patients as assessed by the physician suffering from documented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment
- Patients treated with:
- bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,
- bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,
- bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe
- initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatin simultaneously
6\) Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.
8\) No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy > 1 -year
Критерии исключения
- Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
- Patients who have ever received PCSK9i-siRNA treatment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 43 центра
Список центров уточняется — проверьте первичный протокол.
Германия · 38 центров
- Praxis für Kardiologie Aachen — Aachen
- Klinikum Ahaus — Ahaus
- Praxis W. Almohamed — Alsfed
- Zentrum für klinische Studien Bad Homburg — Bad Homburg
- Dialysezentrum Hellersdorf Mitte — Berlin
- Lipidambulanz Charite Campus Virchow — Berlin
- MEDICLIN Reha-Zentrum Spreewald — Burg
- Kardiologische Gemeinschaftspraxis Flemmingstr. — Chemnitz
- … и ещё 30 центров
Испания · 36 центров
Список центров уточняется — проверьте первичный протокол.
Австрия · 24 центра
- Innere Medizin — Braunau am Inn
- Innere Medizin 1 — Feldkirch
- Uniklinik Graz, Endokrinologie und Diabetes — Graz
- Uniklinik Graz, Kardiologie — Graz
- Innere Medizin 3 - Kardiologie — Innsbruck
- Klinikum Wels-Grieskirchen GmbH+B18 — Kepler Universitätsklinikum Gmb+
- Innere Medizin — Klagenfurt
- Innere Medizin — Linz
- … и ещё 16 центров
Бельгия · 22 центра
- Azorg — Aalst
- UZA (Antwerp University Hospital) — Antwerp
- Epicure Hornu — Boussu
- A.Z. KLINA Brasschaat — Brasschaat
- Algemeen Ziekenhuis Sint-Jan Oostende — Bruges
- CHU Brugman — Brussels
- UZ Brussel — Brussels
- CHU Charleroi Hopital civil Marie-Curie — Charleroi
- … и ещё 14 центров
Идентификаторы
NCT: NCT06686615 · DSE-BMP-01-24-EU