NCT06686615Active, not recruiting
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 11 Nov 2024
- Start date
- 12 Feb 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06686615
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 12 Feb 2025 to the primary completion date, 31 Jul 2027
- 163 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (163)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Innere Medizin Coordinator of this site? Confirm its status | Braunau am Inn | Austria | Unknown status |
| Innere Medizin 1 Coordinator of this site? Confirm its status | Feldkirch | Austria | Unknown status |
| Uniklinik Graz, Endokrinologie und Diabetes Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Uniklinik Graz, Kardiologie Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Innere Medizin 3 - Kardiologie Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Klinikum Wels-Grieskirchen GmbH+B18 Coordinator of this site? Confirm its status | Kepler Universitätsklinikum Gmb+ | Austria | Unknown status |
| Innere Medizin Coordinator of this site? Confirm its status | Klagenfurt | Austria | Unknown status |
| Innere Medizin Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Ordination Coordinator of this site? Confirm its status | Mattersburg | Austria | Unknown status |
| Landesklinikum Mistelbach - Gänserndorf Coordinator of this site? Confirm its status | Mistelbach | Austria | Unknown status |
| Ordination Dr. med. univ. Evelyn Fließer-Görzer Coordinator of this site? Confirm its status | Saint Stefan Bei Graz | Austria | Unknown status |
| Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer) Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Herzzentrum 18 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Ordination Univ.-Prof. Dr. Kurt Huber Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Klinik Landstrasse, Kardiologie Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Clinic Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Akh Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Meduni Wien, Endokrinologie und Diabetes Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Meduni Wien, Kardiologie Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Zentrum für klinische Studien Dr Hanusch Gmbh Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| AZORG Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| UZA (Antwerp University Hospital) Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Epicure Hornu Coordinator of this site? Confirm its status | Boussu | Belgium | Unknown status |
| A.Z. KLINA Brasschaat Coordinator of this site? Confirm its status | Brasschaat | Belgium | Unknown status |
| Algemeen Ziekenhuis Sint-Jan Oostende Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| CHU Brugman Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| UZ Brussel Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| GHDC Charleroi - Site Hôpital Saint-Joseph Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| CHU Charleroi Hopital civil Marie-Curie Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| Z.O.L - Campus St. Jan Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| AZ Sint-Lucas Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| CHR Huy Coordinator of this site? Confirm its status | Huy | Belgium | Unknown status |
| AZ Groeninge, Kortrijk Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| Pôle hospitalier Jolimont Coordinator of this site? Confirm its status | La Louvrière | Belgium | Unknown status |
| Jan Yperman Ziekenhuis Coordinator of this site? Confirm its status | Leper | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHR Citadelle de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| CHU Mons Ambroise Paré Coordinator of this site? Confirm its status | Mons | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| az Glorieux Coordinator of this site? Confirm its status | Ronse | Belgium | Unknown status |
| CHU UCL Mont-Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
| Praxis für Kardiologie Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Klinikum Ahaus Coordinator of this site? Confirm its status | Ahaus | Germany | Unknown status |
| Praxis W. Almohamed Coordinator of this site? Confirm its status | Alsfed | Germany | Unknown status |
| Zentrum für Klinische Studien Bad Homburg Coordinator of this site? Confirm its status | Bad Homburg | Germany | Unknown status |
| Lipidambulanz Charite Campus Virchow Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Dialysezentrum Hellersdorf Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| MediClin Reha-Zentrum Spreewald Coordinator of this site? Confirm its status | Burg | Germany | Unknown status |
| Kardiologische Gemeinschaftspraxis Flemmingstr. Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Klinik Detmold Coordinator of this site? Confirm its status | Detmold | Germany | Unknown status |
| Praxis Dr. Methfessel Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Cardiologicum Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Herz- und Gefäßmedizin Goslar Coordinator of this site? Confirm its status | Goslar | Germany | Unknown status |
| ndgl.; viele Kombinationstherapien Coordinator of this site? Confirm its status | Gräfenhainichen | Germany | Unknown status |
| Praxis Coordinator of this site? Confirm its status | Greiz | Germany | Unknown status |
| Kardiologie am Tibarg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Jessa Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Germany | Unknown status |
| Uni-Klinik Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| HPK Heidelberger Praxisklinik Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Kardiopraxis Coordinator of this site? Confirm its status | Kaiserslautern | Germany | Unknown status |
| GK Mittelrhein Coordinator of this site? Confirm its status | Koblenz | Germany | Unknown status |
| Klinikum Konstanz Coordinator of this site? Confirm its status | Konstanz | Germany | Unknown status |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| DRK Krankenhaus Lichtenstein Gemeinnützige GmbH Coordinator of this site? Confirm its status | Lichtenstein | Germany | Unknown status |
| Cardio Centrum Ludwigsburg Coordinator of this site? Confirm its status | Ludwigsburg | Germany | Unknown status |
| Kardiopraxis Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Kardiologische Praxis Markkleeberg Coordinator of this site? Confirm its status | Markkleeberg | Germany | Unknown status |
| Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking Coordinator of this site? Confirm its status | Moers | Germany | Unknown status |
| Praxis Dr. Norbert Schön Coordinator of this site? Confirm its status | Mühldorf A. Inn | Germany | Unknown status |
| Kardiologische Gemeinschaftpraxis Papenburg Coordinator of this site? Confirm its status | Papenburg | Germany | Unknown status |
| Kardiologische Gemeinschaftspraxis Papenburg Coordinator of this site? Confirm its status | Papenburg | Germany | Unknown status |
| Hausärztlich- Kardiologisches MVZ "Am Felsenkeller" GmbH Coordinator of this site? Confirm its status | Pirna | Germany | Unknown status |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| Lipidambulanz Uniklinikum Regensburg Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Parkkardiologie, kard. Gemeinschaftspraxis Coordinator of this site? Confirm its status | Stanhsdorf B. Berlin | Germany | Unknown status |
| Diabetologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Trier | Germany | Unknown status |
| BBT Trier Coordinator of this site? Confirm its status | Trier | Germany | Unknown status |
| Herzklinik Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Dialysezentrum Hofaue Coordinator of this site? Confirm its status | Wuppertal | Germany | Unknown status |
| H. Univers. De Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| H. General de Elche Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario de San Juan Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Unknown status |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| H. Univ. Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| H. Punta de Europa Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital Universitario Puerto Real Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Sierrallana Hospital Coordinator of this site? Confirm its status | Cantabria | Spain | Unknown status |
| H. Univ. Reina Sofía Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario de Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| H. Univ. De Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| H. Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| H Juan Ramón Jiménez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario Médico-Quirúrgico de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Unknown status |
| Hospital Universitario de Gran Canarias Dr. Negrín Coordinator of this site? Confirm its status | Las Palmas de GC | Spain | Unknown status |
| Hospital de León Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Unknown status |
| Hospital Serranía de Ronda Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| H. Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| H. Costa del Sol Coordinator of this site? Confirm its status | Marbella (Málaga) | Spain | Unknown status |
| H. Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital General Universitario Reina Sofía Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital de Segovia Coordinator of this site? Confirm its status | Segovia | Spain | Unknown status |
| Hospital General Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
| H. Clínico Univ. de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Consorcio Hospital General Univ de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario de Álava Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
| Hospital Clinico Universitaro Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Ente Ecclesiastico "Miulli" Coordinator of this site? Confirm its status | Acquaviva delle Fonti | Italy | Unknown status |
| INRCA Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| AO Moscati Coordinator of this site? Confirm its status | Avellino | Italy | Unknown status |
| Osp. "San Paolo" Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Ospedale di Bolzano Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Osp. santo spirito Coordinator of this site? Confirm its status | Casale Monferrato | Italy | Unknown status |
| Ospedale Sant'Anna e san Sebastiano Coordinator of this site? Confirm its status | Caserta | Italy | Unknown status |
| Policlinnico Mater Domini Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Osp. SS Annunziata Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| PO Nuovo Umberti I Coordinator of this site? Confirm its status | Enna | Italy | Unknown status |
| Osp. Sant'Anna di Cona Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Policlinico "Riuniti" Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Osp della Misericordia Coordinator of this site? Confirm its status | Grosseto | Italy | Unknown status |
| Osp. "Vito Fazzi" Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Ospedale Mater Salutis Coordinator of this site? Confirm its status | Legnagno | Italy | Unknown status |
| Spedali Riuniti Coordinator of this site? Confirm its status | Livorno | Italy | Unknown status |
| Ospedale di Mantova Coordinator of this site? Confirm its status | Mantua | Italy | Unknown status |
| Policlinico G. Martino Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| IRCCS Galeazzi-Sant'Ambrogio Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS Monzino Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Policlinico Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Policlinico Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AO Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AOU Vanvitelli, I Policlinico Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Policlinico P. Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| ICS Maugeri Coordinator of this site? Confirm its status | Pavi | Italy | Unknown status |
| S. Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Presidio Ospedaliero Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Ospedale PederzoliItlit Coordinator of this site? Confirm its status | Peschiera | Italy | Unknown status |
| Cisanello Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Osp. Santa Maria delle Croci Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Osp infermi di rivoli Coordinator of this site? Confirm its status | Rivoli | Italy | Unknown status |
| Ospedale Pertini Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale Sant'Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Molinette Università to Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedale Mauriziano Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Osp. di Cattinara Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
| Ospedale di Portogruaro Coordinator of this site? Confirm its status | Venezia | Italy | Unknown status |
| AOUI Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
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