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

Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Innere Medizin 1
ACTIVE_NOT_RECRUITING
Feldkirch
Ordination
ACTIVE_NOT_RECRUITING
Mattersburg
Ordination Dr. med. univ. Evelyn Fließer-Görzer
RECRUITING
Saint Stefan Bei Graz
DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen
ACTIVE_NOT_RECRUITING
Salzburg
Herzzentrum 18
RECRUITING
Vienna
Zentrum für Klinische Studien Dr. Hanusch GmbH
ACTIVE_NOT_RECRUITING
Vienna
Belgium
A.Z. KLINA Brasschaat
ACTIVE_NOT_RECRUITING
Brasschaat
Algemeen Ziekenhuis Sint-Jan Oostende
ACTIVE_NOT_RECRUITING
Bruges
Z.O.L - Campus St. Jan
ACTIVE_NOT_RECRUITING
Genk
AZ Groeninge Kortrijk
ACTIVE_NOT_RECRUITING
Kortrijk
AZ Delta
RECRUITING
Roeselare
AZ Glorieux
ACTIVE_NOT_RECRUITING
Ronse
Germany
Zentrum für klinische Studien Bad Homburg
RECRUITING
Bad Homburg
MEDICLIN Reha-Zentrum Spreewald
ACTIVE_NOT_RECRUITING
Burg
Kardiologische Gemeinschaftspraxis Flemmingstr.
RECRUITING
Chemnitz
Cardiologicum Dresden
RECRUITING
Dresden
Praxis Dr. Methfessel
ACTIVE_NOT_RECRUITING
Dresden
Herz- und Gefäßmedizin Goslar
ACTIVE_NOT_RECRUITING
Goslar
ndgl.; viele Kombinationstherapien
ACTIVE_NOT_RECRUITING
Gräfenhainichen
Praxis
RECRUITING
Greiz
Kardiopraxis
RECRUITING
Kaiserslautern
GK Mittelrhein
ACTIVE_NOT_RECRUITING
Koblenz
Klinikum Konstanz
RECRUITING
Konstanz
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Cardio Centrum Ludwigsburg
RECRUITING
Ludwigsburg
Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking
RECRUITING
Moers
Praxis Dr. Norbert Schön
ACTIVE_NOT_RECRUITING
Mühldorf A. Inn
Kardiologische Gemeinschaftpraxis Papenburg
RECRUITING
Papenburg
Kardiologische Gemeinschaftspraxis Papenburg
RECRUITING
Papenburg
Kardiologische Gemeinschaftspraxis am Park Sanssouci
RECRUITING
Potsdam
Parkkardiologie, kard. Gemeinschaftspraxis
ACTIVE_NOT_RECRUITING
Stanhsdorf B. Berlin
Diabetologische Schwerpunktpraxis
RECRUITING
Trier
Herzklinik
ACTIVE_NOT_RECRUITING
Ulm
Italy
Ospedale di Mantova
RECRUITING
Mantova
Policlinico P. Giaccone
ACTIVE_NOT_RECRUITING
Palermo
Ospedale PederzoliItlit
ACTIVE_NOT_RECRUITING
Peschiera
Policlinico Umberto I
RECRUITING
Rome
Spain
Hospital Universitario de Gran Canarias Dr. Negrín
ACTIVE_NOT_RECRUITING
Las Palmas De Gc
Hospital de León
ACTIVE_NOT_RECRUITING
León
H. Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario Central de Asturias
ACTIVE_NOT_RECRUITING
Oviedo
Hospital Universitario de Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital de Segovia
ACTIVE_NOT_RECRUITING
Segovia
Contact Information
Primary
Daiichi Sankyo Contact for Clinical Trial Information
CTRinfo_us@daiichisankyo.com
9089926400
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 2000
Treatments
Triple therapy
Adult patients who have been diagnosed with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia treated with bempedoic acid in combination with ezetimibe and either rosuvastatin or atorvastatin (ie, triple therapy) and will be followed for up to 1 year after initiation of triple therapy.~A direct comparison between rosuvastatin and atorvastatin is not planned, only an assessment of triple therapy on LDL-C change in patients with primary hypercholesterolaemia.
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

This content was sourced from clinicaltrials.gov

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