A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Recruiting · NCT06686615 · Observational (researchers observe without assigning treatment) · Lead sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
- \) 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.
- \) 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
- Key
Exclusion criteria
- 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
Where it is running
60 locations listed.
- Praxis für Kardiologie Aachen - Aachen, Germany
- Azorg - Aalst, Belgium
- Ente Ecclesiastico "Miulli" - Acquaviva delle Fonti, Italy
- Klinikum Ahaus - Ahaus, Germany
- H. Univers. De Albacete - Albacete, Spain
- Hospital General Universitario Dr. Balmis - Alicante, Spain
- H. General de Elche - Alicante, Spain
- Hospital Universitario de San Juan - Alicante, Spain
- Praxis W. Almohamed - Alsfed, Germany
- INRCA - Ancona, Italy
- UZA (Antwerp University Hospital) - Antwerp, Belgium
- AO Moscati - Avellino, Italy
- Zentrum für klinische Studien Bad Homburg - Bad Homburg, Germany
- Hospital Universitario de Cruces - Barakaldo, Spain
- Osp. "San Paolo" - Bari, Italy
- Dialysezentrum Hellersdorf Mitte - Berlin, Germany
- Lipidambulanz Charite Campus Virchow - Berlin, Germany
- Ospedale di Bolzano - Bolzano, Italy
- Epicure Hornu - Boussu, Belgium
- A.Z. KLINA Brasschaat - Brasschaat, Belgium
- Innere Medizin - Braunau am Inn, Austria
- Spedali Civili di Brescia - Brescia, Italy
- Algemeen Ziekenhuis Sint-Jan Oostende - Bruges, Belgium
- CHU Brugman - Brussels, Belgium
- UZ Brussel - Brussels, Belgium
- MEDICLIN Reha-Zentrum Spreewald - Burg, Germany
- Hospital Universitario de Burgos - Burgos, Spain
- H. Univ. Puerta del Mar - Cadiz, Spain
- H. Punta de Europa - Cadiz, Spain
- Hospital Universitario Puerto Real - Cadiz, Spain
- Sierrallana Hospital - Cantabria, Spain
- Osp. santo spirito - Casale Monferrato, Italy
- Ospedale Sant'Anna e san Sebastiano - Caserta, Italy
- Policlinnico Mater Domini - Catanzaro, Italy
- CHU Charleroi Hopital civil Marie-Curie - Charleroi, Belgium
- GHDC Charleroi - Site Hôpital Saint-Joseph - Charleroi, Belgium
- Kardiologische Gemeinschaftspraxis Flemmingstr. - Chemnitz, Germany
- Osp. SS Annunziata - Chieti, Italy
- H. Univ. Reina Sofía - Córdoba, Spain
- Klinik Detmold - Detmold, Germany
- Hospital Universitario de Donostia - Donostia / San Sebastian, Spain
- Praxis Dr. Methfessel - Dresden, Germany
- Cardiologicum Dresden - Dresden, Germany
- PO Nuovo Umberti I - Enna, Italy
- Innere Medizin 1 - Feldkirch, Austria
- Osp. Sant'Anna di Cona - Ferrara, Italy
- Policlinico "Riuniti" - Foggia, Italy
- Z.O.L - Campus St. Jan - Genk, Belgium
- Policlinico San Martino - Genova, Italy
- Az Sint Lucas - Ghent, Belgium
- UZ Gent - Ghent, Belgium
- H. Univ. De Cabueñes - Gijón, Spain
- Herz- und Gefäßmedizin Goslar - Goslar, Germany
- H. Virgen de las Nieves - Granada, Spain
- Uniklinik Graz, Endokrinologie und Diabetes - Graz, Austria
- Uniklinik Graz, Kardiologie - Graz, Austria
- Praxis - Greiz, Germany
- Osp della Misericordia - Grosseto, Italy
- ndgl.; viele Kombinationstherapien - Gräfenhainichen, Germany
- Kardiologie am Tibarg - Hamburg, Germany
Showing 60 of 163 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →