Using bempedoic acid and ezetimibe to manage cholesterol levels in patients with high cholesterol
Non-interventional Study on the Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS)
This study is trying to see how well bempedoic acid and ezetimibe work to lower cholesterol levels in people with high cholesterol who are already using these medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Daiichi Sankyo Industry-sponsored |
| Locations | 489 sites (Dornbirn and 488 other locations) |
| Trial ID | NCT04579367 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the characteristics and outcomes of patients with primary hypercholesterolemia or mixed dyslipidemia who are treated with bempedoic acid and/or its fixed-dose combination with ezetimibe. The study will evaluate the effectiveness of these treatments in managing low-density lipoprotein cholesterol (LDL-C) levels and assess cardiovascular risk using various risk scoring systems. A total of 5000 participants will be included, treated by both specialized and non-specialized physicians in various clinical settings. The study will not influence prescribing behavior, focusing instead on the outcomes of patients already prescribed these medications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with documented primary hypercholesterolemia or mixed dyslipidemia who are being treated or are intended to be treated with bempedoic acid and/or its fixed-dose combination with ezetimibe.
Not a fit: Patients who do not have primary hypercholesterolemia or mixed dyslipidemia, or those who are not being treated with the specified medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of bempedoic acid and ezetimibe in managing cholesterol levels, potentially improving treatment strategies for patients with high cholesterol.
How similar studies have performed: Other studies have explored the use of bempedoic acid and ezetimibe, but this study aims to provide real-world evidence, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent to participate * At least 18 years of age * Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia treated or intended to be treated with bempedoic acid and/or its fixed dose combination with ezetimibe at the discretion of the physician are appropriate for participation in the observation. * No contraindications exist according to the SmPC of bempedoic acid and/or its fixed-dose combination with ezetimibe * No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible) * Life expectancy \> 1 year Exclusion Criteria: * As this is a non-interventional study, no explicit exclusion criteria are defined. The prescribing behavior will not be influenced. Only patients will be included where the decision has been made by the treating physician to treat the patients either with bempedoic acid and/or its fixed-dose combination with ezetimibe.
Where this trial is running
Dornbirn and 488 other locations
- Dr. Armin Öhlinger Kardiologe & innere Medizin — Dornbirn, Austria (Completed)
- Landeskrankenhaus Feldkirch — Feldkirch, Austria (Completed)
- Institut für Herz- und Gefäßerkrankungen GmbH — Graz, Austria (Withdrawn)
- LKH-Univ. Klinikum Graz — Graz, Austria (Completed)
- Medizinische Universität Graz — Graz, Austria (Completed)
- Internist Dr. med. univ. Stefan Moser — Horsching, Austria (Completed)
- Medizinische Universität Innsbruck — Innsbruck, Austria (Completed)
- KABEG Klinikum Klagenfurt am Wörthersee — Klagenfurt am Worthersee, Austria (Completed)
- Konventhospital der Barmherzigen Brüder Linz — Linz, Austria (Completed)
- Ordination Dr. Johannes Föchterle — Linz, Austria (Completed)
- Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl — Mattersburg, Austria (Completed)
- Landesklinikum Melk — Melk, Austria (Withdrawn)
- Kompetenz-Zentrum Diabetes — Salzburg, Austria (Completed)
- Ordination Universitätsdozent Dr. Alexander Kober — Sankt Aegyd Am Neuwalde, Austria (Completed)
- Ordination Dr. med. univ. Evelyn Fließer-Görzer — Sankt Stefan Ob Stainz, Austria (Completed)
- Landeskrankenhaus Villach — Villach, Austria (Withdrawn)
- Ordination Dr. Thomas Maca — Wien, Austria (Completed)
- Klinik Hietzing, Wiener Gesundheitsverbund — Wien, Austria (Completed)
- Zentrum für Klinische Studien Dr. Hanusch GmbH — Wien, Austria (Completed)
- Allgemeines Krankenhaus der Stadt Wien — Wien, Austria (Completed)
- Univ.-Prof. Dr. Thomas Stulnig — Wien, Austria (Completed)
- Herz Zentrum Währing — Wien, Austria (Completed)
- Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung — Wien, Austria (Completed)
- Schnürer & Fritsch - Gruppenpraxis für Innere Medizin — Wien, Austria (Withdrawn)
- Asz — Aalst, Belgium (Completed)
- Clinique Saint-Luc Bouge Namur — Bouge, Belgium (Completed)
- Epicura Hornu — Boussu, Belgium (Completed)
- A.Z. KLINA Brasschaat — Brasschaat, Belgium (Completed)
- Clinique Saint-Jean Bruxelles — Bruxelles, Belgium (Completed)
- CHU Brugman — Bruxelles, Belgium (Completed)
- CUB-Hôpital Erasme — Bruxelles, Belgium (Completed)
- UZ Brussel — Bruxelles, Belgium (Completed)
- Clinique de l'Europe Saint Elisabeth — Bruxelles, Belgium (Completed)
- UCL Saint-Luc Woluwé Bruxelles — Bruxelles, Belgium (Completed)
- Private Practice — Ciney, Belgium (Completed)
- Az Sint Blazius — Dendermonde, Belgium (Completed)
- UZ Antwerpen — Edegem, Belgium (Completed)
- Z.O.L - Campus St. Jan — Genk, Belgium (Completed)
- AZ St-Lucas & Volkskliniek — Ghent, Belgium (Completed)
- UZ Gent — Ghent, Belgium (Completed)
- GHDC Charleroi - Site Hôpital Saint-Joseph — Gilly, Belgium (Completed)
- Private Practice — Gribomont, Belgium (Completed)
- Pôle hospitalier Jolimont — Haine-Saint-Paul, Belgium (Completed)
- BVBA Med Kab — Halen, Belgium (Completed)
- Jessa Ziekenhuis — Hasselt, Belgium (Completed)
- CHR Huy — Huy, Belgium (Completed)
- JAN YPERMAN Ziekenhuis — Ieper, Belgium (Completed)
- AZ Groeninge Kortrijk — Kortrijk, Belgium (Completed)
- CHU Tivoli — La Louvière, Belgium (Completed)
- UZ Leuven — Leuven, Belgium (Completed)
+439 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information
- Email: CTRinfo@dsi.com
- Phone: 908-992-6400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.