A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (TRICONOS)

May 4, 2026 updated by: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daiichi Sankyo Contact for Clinical Trial Information
Phone Number: 9089926400
Email: CTRinfo_us@daiichisankyo.com

Study Locations

Austria
- - Braunau am Inn, Austria, 5280
    - Recruiting
    - Innere Medizin
    - Contact:
      
      Principal Investigator
  - Feldkirch, Austria, 6800
    - Recruiting
    - Innere Medizin 1
    - Contact:
      
      Principal Investigator
  - Graz, Austria, 8036
    - Recruiting
    - Uniklinik Graz, Endokrinologie und Diabetes
    - Contact:
      
      Principal Investigator
  - Graz, Austria, 8036
    - Recruiting
    - Uniklinik Graz, Kardiologie
    - Contact:
      
      Principal Investigator
  - Innsbruck, Austria, 6020
    - Recruiting
    - Innere Medizin 3 - Kardiologie
    - Contact:
      
      Principal Investigator
  - Kepler Universitätsklinikum Gmb+, Austria, 4600
    - Active, not recruiting
    - Klinikum Wels-Grieskirchen GmbH+B18
  - Klagenfurt, Austria, 9020
    - Recruiting
    - Innere Medizin
    - Contact:
      
      Principal Investigator
  - Linz, Austria, 4040
    - Recruiting
    - Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
    - Contact:
      
      Principal Investigator
  - Linz, Austria, 4021
    - Recruiting
    - Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
    - Contact:
      
      Principal Investigator
  - Linz, Austria, 4020
    - Recruiting
    - Innere Medizin
    - Contact:
      
      Principal Investigator
  - Mattersburg, Austria, 7210
    - Recruiting
    - Ordination
    - Contact:
      
      Principal Investigator
  - Mistelbach, Austria, 2130
    - Active, not recruiting
    - Landesklinikum Mistelbach - Gänserndorf
  - Saint Stefan Bei Graz, Austria, 8511
    - Recruiting
    - Ordination Dr. med. univ. Evelyn Fließer-Görzer
    - Contact:
      
      Principal Investigator
  - Salzburg, Austria, 5026
    - Recruiting
    - DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen
    - Contact:
      
      Principal Investigator
  - Salzburg, Austria, 5020
    - Recruiting
    - Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1090
    - Recruiting
    - AKH Wien
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1180
    - Recruiting
    - Herzzentrum 18
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1060
    - Active, not recruiting
    - Zentrum für Klinische Studien Dr. Hanusch GmbH
  - Vienna, Austria, 1060
    - Active, not recruiting
    - Ordination Univ.-Prof. Dr. Kurt Huber
  - Vienna, Austria, 1090
    - Recruiting
    - Meduni Wien, Kardiologie
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1130
    - Recruiting
    - Clinic Hietzing
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1090
    - Recruiting
    - Meduni Wien, Endokrinologie und Diabetes
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1030
    - Recruiting
    - Klinik Landstrasse, Kardiologie
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1210
    - Recruiting
    - Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf
    - Contact:
      
      Principal Investigator
Belgium
- - Aalst, Belgium, 9300
    - Recruiting
    - AZORG
    - Contact:
      
      Principal Investigator
  - Antwerp, Belgium, 2650
    - Active, not recruiting
    - UZA (Antwerp University Hospital)
  - Boussu, Belgium, 7301
    - Recruiting
    - Epicure Hornu
    - Contact:
      
      Principal Investigator
  - Brasschaat, Belgium, 2930
    - Recruiting
    - A.Z. KLINA Brasschaat
    - Contact:
      
      Principal Investigator
  - Bruges, Belgium, 8400
    - Recruiting
    - Algemeen Ziekenhuis Sint-Jan Oostende
    - Contact:
      
      Principal Investigator
  - Brussels, Belgium, 1090
    - Active, not recruiting
    - UZ Brussel
  - Brussels, Belgium, 1020
    - Active, not recruiting
    - CHU Brugman
  - Charleroi, Belgium, 6042
    - Recruiting
    - CHU Charleroi Hopital civil Marie-Curie
    - Contact:
      
      Principal Investigator
  - Charleroi, Belgium, 6060
    - Recruiting
    - GHDC Charleroi - Site Hôpital Saint-Joseph
    - Contact:
      
      Principal Investigator
  - Genk, Belgium, 3600
    - Recruiting
    - Z.O.L - Campus St. Jan
    - Contact:
      
      Principal Investigator
  - Ghent, Belgium, 9000
    - Active, not recruiting
    - UZ Gent
  - Ghent, Belgium, 9000
    - Active, not recruiting
    - AZ Sint Lucas
  - Huy, Belgium, 4500
    - Active, not recruiting
    - CHR Huy
  - Kortrijk, Belgium, 8500
    - Recruiting
    - AZ Groeninge Kortrijk
    - Contact:
      
      Principal Investigator
  - La Louvrière, Belgium, 7100
    - Recruiting
    - Pôle Hospitalier Jolimont
    - Contact:
      
      Principal Investigator
  - Leper, Belgium, 8900
    - Recruiting
    - Jan Yperman Ziekenhuis
    - Contact:
      
      Principal Investigator
  - Leuven, Belgium, 3000
    - Recruiting
    - UZ Leuven
    - Contact:
      
      Principal Investigator
  - Liège, Belgium, 4000
    - Active, not recruiting
    - CHR Citadelle de Liège
  - Mons, Belgium, 7000
    - Active, not recruiting
    - CHU Mons Ambroise Paré
  - Roeselare, Belgium, 8800
    - Recruiting
    - AZ Delta
    - Contact:
      
      Principal Investigator
  - Ronse, Belgium, 9600
    - Recruiting
    - AZ Glorieux
    - Contact:
      
      Principal Investigator
  - Yvoir, Belgium, 5530
    - Recruiting
    - CHU UCL Mont-Godinne
    - Contact:
      
      Principal Investigator
Germany
- - Aachen, Germany, 52062
    - Recruiting
    - Praxis für Kardiologie Aachen
    - Contact:
      
      Principal Investigator
  - Ahaus, Germany, 48683
    - Recruiting
    - Klinikum Ahaus
    - Contact:
      
      Principal Investigator
  - Alsfed, Germany, 36304
    - Recruiting
    - Praxis W. Almohamed
    - Contact:
      
      Principal Investigator
  - Bad Homburg, Germany, 61348
    - Recruiting
    - Zentrum für klinische Studien Bad Homburg
    - Contact:
      
      Principal Investigator
  - Berlin, Germany, 13353
    - Recruiting
    - Lipidambulanz Charite Campus Virchow
    - Contact:
      
      Principal Investigator
  - Berlin, Germany, 12627
    - Recruiting
    - Dialysezentrum Hellersdorf Mitte
    - Contact:
      
      Principal Investigator
  - Burg, Germany, 03096
    - Recruiting
    - MEDICLIN Reha-Zentrum Spreewald
    - Contact:
      
      Principal Investigator
  - Chemnitz, Germany, 09116
    - Recruiting
    - Kardiologische Gemeinschaftspraxis Flemmingstr.
    - Contact:
      
      Principal Investigator
  - Detmold, Germany, 32756
    - Recruiting
    - Klinik Detmold
    - Contact:
      
      Principal Investigator
  - Dresden, Germany, 01796
    - Recruiting
    - Cardiologicum Dresden
    - Contact:
      
      Principal Investigator
  - Dresden, Germany, 01159
    - Recruiting
    - Praxis Dr. Methfessel
    - Contact:
      
      Principal Investigator
  - Goslar, Germany, 38640
    - Recruiting
    - Herz- und Gefäßmedizin Goslar
    - Contact:
      
      Principal Investigator
  - Greiz, Germany, 07973
    - Recruiting
    - Praxis
    - Contact:
      
      Principal Investigator
  - Gräfenhainichen, Germany, 06773
    - Active, not recruiting
    - ndgl.; viele Kombinationstherapien
  - Hamburg, Germany, 22459
    - Recruiting
    - Kardiologie am Tibarg
    - Contact:
      
      Principal Investigator
  - Hasselt, Germany, 3500
    - Recruiting
    - Jessa Ziekenhuis
    - Contact:
      
      Principal Investigator
  - Heidelberg, Germany, 69115
    - Recruiting
    - HPK Heidelberger Praxisklinik
    - Contact:
      
      Principal Investigator
  - Heidelberg, Germany, 69120
    - Recruiting
    - Uni-Klinik Heidelberg
    - Contact:
      
      Principal Investigator
  - Kaiserslautern, Germany, 67655
    - Recruiting
    - Kardiopraxis
    - Contact:
      
      Principal Investigator
  - Koblenz, Germany, 56073
    - Recruiting
    - GK Mittelrhein
    - Contact:
      
      Principal Investigator
  - Konstanz, Germany, 78464
    - Recruiting
    - Klinikum Konstanz
    - Contact:
      
      Principal Investigator
  - Leipzig, Germany, 04103
    - Recruiting
    - Universitatsklinikum Leipzig
    - Contact:
      
      Principal Investigator
  - Lichtenstein, Germany, 09350
    - Recruiting
    - DRK Krankenhaus Lichtenstein Gemeinnützige GmbH
    - Contact:
      
      Principal Investigator
  - Ludwigsburg, Germany, 71634
    - Recruiting
    - Cardio Centrum Ludwigsburg
    - Contact:
      
      Principal Investigator
  - Mainz, Germany, 55122
    - Recruiting
    - Kardiopraxis
    - Contact:
      
      Principal Investigator
  - Markkleeberg, Germany, 04416
    - Recruiting
    - Kardiologische Praxis Markkleeberg
    - Contact:
      
      Principal Investigator
  - Moers, Germany, 47441
    - Recruiting
    - Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking
    - Contact:
      
      Principal Investigator
  - Mühldorf A. Inn, Germany, 84453
    - Recruiting
    - Praxis Dr. Norbert Schön
    - Contact:
      
      Principal Investigator
  - Papenburg, Germany, 26871
    - Recruiting
    - Kardiologische Gemeinschaftspraxis Papenburg
    - Contact:
      
      Principal Investigator
  - Papenburg, Germany, 26871
    - Recruiting
    - Kardiologische Gemeinschaftpraxis Papenburg
    - Contact:
      
      Principal Investigator
  - Pirna, Germany, 01796
    - Recruiting
    - Hausärztlich-kardiologisches MVZ,,Am Felsenkeller" GmbH
    - Contact:
      
      Principal Investigator
  - Potsdam, Germany, 14469
    - Recruiting
    - Kardiologische Gemeinschaftspraxis am Park Sanssouci
    - Contact:
      
      Principal Investigator
  - Regensburg, Germany, 93053
    - Recruiting
    - Lipidambulanz Uniklinikum Regensburg
    - Contact:
      
      Principal Investigator
  - Stanhsdorf B. Berlin, Germany, 14532
    - Recruiting
    - Parkkardiologie, kard. Gemeinschaftspraxis
    - Contact:
      
      Principal Investigator
  - Trier, Germany, 54292
    - Recruiting
    - Diabetologische Schwerpunktpraxis
    - Contact:
      
      Principal Investigator
  - Trier, Germany, 54292
    - Active, not recruiting
    - BBT Trier
  - Ulm, Germany, 89077
    - Recruiting
    - Herzklinik
    - Contact:
      
      Principal Investigator
  - Wuppertal, Germany, 42103
    - Active, not recruiting
    - Dialysezentrum Hofaue
Italy
- - Acquaviva delle Fonti, Italy, 70021
    - Recruiting
    - Ente Ecclesiastico "Miulli"
    - Contact:
      
      Principal Investigator
  - Ancona, Italy, 60127
    - Recruiting
    - INRCA
    - Contact:
      
      Principal Investigator
  - Avellino, Italy, 83100
    - Recruiting
    - AO Moscati
    - Contact:
      
      Principal Investigator
  - Bari, Italy, 70123
    - Recruiting
    - Osp. "San Paolo"
    - Contact:
      
      Principal Investigator
  - Bolzano, Italy, 39100
    - Recruiting
    - Ospedale di Bolzano
    - Contact:
      
      Principal Investigator
  - Brescia, Italy, 25123
    - Recruiting
    - Spedali Civili di Brescia
    - Contact:
      
      Principal Investigator
  - Casale Monferrato, Italy, 15033
    - Recruiting
    - Osp. santo spirito
    - Contact:
      
      Principal Investigator
  - Caserta, Italy, 81100
    - Recruiting
    - Ospedale Sant'Anna e san Sebastiano
    - Contact:
      
      Principal Investigator
  - Catanzaro, Italy, 88100
    - Active, not recruiting
    - Policlinnico Mater Domini
  - Chieti, Italy, 66100
    - Recruiting
    - Osp. SS Annunziata
    - Contact:
      
      Principal Investigator
  - Enna, Italy, 94100
    - Recruiting
    - PO Nuovo Umberti I
    - Contact:
      
      Principal Investigator
  - Ferrara, Italy, 44124
    - Recruiting
    - Osp. Sant'Anna di Cona
    - Contact:
      
      Principal Investigator
  - Foggia, Italy, 71122
    - Recruiting
    - Policlinico "Riuniti"
    - Contact:
      
      Principal Investigator
  - Genova, Italy, 16132
    - Recruiting
    - Policlinico San Martino
    - Contact:
      
      Principal Investigator
  - Grosseto, Italy, 58100
    - Recruiting
    - Osp della Misericordia
    - Contact:
      
      Principal Investigator
  - Lecce, Italy, 73100
    - Recruiting
    - Osp. "Vito Fazzi"
    - Contact:
      
      Principal Investigator
  - Legnagno, Italy, 37045
    - Recruiting
    - Ospedale Mater Salutis
    - Contact:
      
      Principal Investigator
  - Livorno, Italy, 57124
    - Recruiting
    - Spedali Riuniti
    - Contact:
      
      Principal Investigator
  - Mantua, Italy, 46100
    - Recruiting
    - Ospedale di Mantova
    - Contact:
      
      Principal Investigator
  - Messina, Italy, 98124
    - Recruiting
    - Policlinico G. Martino
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20138
    - Recruiting
    - IRCCS Monzino
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20157
    - Recruiting
    - IRCCS Galeazzi Sant'Ambrogio
    - Contact:
      
      Principal Investigator
  - Modena, Italy, 41125
    - Recruiting
    - Policlinico Modena
    - Contact:
      
      Principal Investigator
  - Naples, Italy, 80131
    - Recruiting
    - AO Cardarelli
    - Contact:
      
      Principal Investigator
  - Naples, Italy, 80131
    - Recruiting
    - Policlinico Federico II
    - Contact:
      
      Principal Investigator
  - Naples, Italy, 80138
    - Recruiting
    - AOU Vanvitelli, I Policlinico
    - Contact:
      
      Principal Investigator
  - Palermo, Italy, 90127
    - Recruiting
    - Policlinico P. Giaccone
    - Contact:
      
      Principal Investigator
  - Pavi, Italy, 27100
    - Recruiting
    - ICS Maugeri
    - Contact:
      
      Principal Investigator
  - Perugia, Italy, 06129
    - Recruiting
    - S. Maria della Misericordia
    - Contact:
      
      Principal Investigator
  - Pescara, Italy, 65124
    - Recruiting
    - Presidio Ospedaliero
    - Contact:
      
      Principal Investigator
  - Peschiera, Italy, 37019
    - Recruiting
    - Ospedale PederzoliItlit
    - Contact:
      
      Principal Investigator
  - Pisa, Italy, 56124
    - Recruiting
    - Cisanello
    - Contact:
      
      Principal Investigator
  - Ravenna, Italy, 48121
    - Recruiting
    - Osp. Santa Maria delle Croci
    - Contact:
      
      Principal Investigator
  - Rivoli, Italy, 10098
    - Recruiting
    - Osp infermi di rivoli
    - Contact:
      
      Principal Investigator
  - Roma, Italy, 00133
    - Recruiting
    - Policlinico Tor Vergata
    - Contact:
      
      Principal Investigator
  - Roma, Italy, 00189
    - Recruiting
    - Ospedale Sant'Andrea
    - Contact:
      
      Principal Investigator
  - Roma, Italy, 00157
    - Recruiting
    - Ospedale Pertini
    - Contact:
      
      Principal Investigator
  - Rome, Italy, 00161
    - Recruiting
    - Policlinico Umberto I
    - Contact:
      
      Principal Investigator
  - Torino, Italy, 10128
    - Recruiting
    - Ospedale Mauriziano
    - Contact:
      
      Principal Investigator
  - Torino, Italy, 10126
    - Recruiting
    - Molinette Università to
    - Contact:
      
      Principal Investigator
  - Trieste, Italy, 34149
    - Recruiting
    - Osp. di Cattinara
    - Contact:
      
      Principal Investigator
  - Venezia, Italy, 30026
    - Recruiting
    - Ospedale di Portogruaro
    - Contact:
      
      Principal Investigator
  - Verona, Italy, 37126
    - Recruiting
    - AOUI Verona
    - Contact:
      
      Principal Investigator
Spain
- - Albacete, Spain, 02006
    - Recruiting
    - H. Univers. De Albacete
    - Contact:
      
      Principal Investigator
  - Alicante, Spain, 03010
    - Recruiting
    - Hospital General Universitario Dr. Balmis
    - Contact:
      
      Principal Investigator
  - Alicante, Spain, 03203
    - Recruiting
    - H. General de Elche
    - Contact:
      
      Principal Investigator
  - Alicante, Spain, 03550
    - Recruiting
    - Hospital Universitario de San Juan
    - Contact:
      
      Principal Investigator
  - Barakaldo, Spain, 48903
    - Recruiting
    - Hospital Universitario de Cruces
    - Contact:
      
      Principal Investigator
  - Burgos, Spain, 09006
    - Recruiting
    - Hospital Universitario de Burgos
    - Contact:
      
      Principal Investigator
  - Cadiz, Spain, 11207
    - Recruiting
    - H. Punta de Europa
    - Contact:
      
      Principal Investigator
  - Cadiz, Spain, 11009
    - Recruiting
    - H. Univ. Puerta del Mar
    - Contact:
      
      Principal Investigator
  - Cadiz, Spain, 11510
    - Recruiting
    - Hospital Universitario Puerto Real
    - Contact:
      
      Principal Investigator
  - Cantabria, Spain, 39300
    - Recruiting
    - Sierrallana Hospital
    - Contact:
      
      Principal Investigator
  - Córdoba, Spain, 14004
    - Active, not recruiting
    - H. Univ. Reina Sofía
  - Donostia / San Sebastian, Spain, 20014
    - Active, not recruiting
    - Hospital Universitario de Donostia
  - Gijón, Spain, 33394
    - Recruiting
    - H. Univ. De Cabueñes
    - Contact:
      
      Principal Investigator
  - Granada, Spain, 18014
    - Recruiting
    - H. Virgen de las Nieves
    - Contact:
      
      Principal Investigator
  - Huelva, Spain, 21005
    - Recruiting
    - H. Juan Ramón Jiménez
    - Contact:
      
      Principal Investigator
  - Jaén, Spain, 23007
    - Recruiting
    - Hospital Universitario Médico-Quirúrgico de Jaén
    - Contact:
      
      Principal Investigator
  - Las Palmas de GC, Spain, 35010
    - Recruiting
    - Hospital Universitario de Gran Canarias Dr. Negrín
    - Contact:
      
      Principal Investigator
  - León, Spain, 24008
    - Recruiting
    - Hospital de Leon
    - Contact:
      
      Principal Investigator
  - Logroño, Spain, 26006
    - Recruiting
    - Hospital San Pedro
    - Contact:
      
      Principal Investigator
  - Marbella (Málaga), Spain, 29603
    - Recruiting
    - H. Costa del Sol
    - Contact:
      
      Principal Investigator
  - Murcia, Spain, 30120
    - Recruiting
    - H. Virgen de la Arrixaca
    - Contact:
      
      Principal Investigator
  - Murcia, Spain, 30003
    - Active, not recruiting
    - Hospital General Universitario Reina Sofia
  - Málaga, Spain, 29010
    - Recruiting
    - H. Virgen de la Victoria
    - Contact:
      
      Principal Investigator
  - Málaga, Spain, 29400
    - Recruiting
    - Hospital Serranía de Ronda
    - Contact:
      
      Principal Investigator
  - Oviedo, Spain, 33011
    - Recruiting
    - Hospital Universitario Central de Asturias
    - Contact:
      
      Principal Investigator
  - Palma de Mallorca, Spain, 07198
    - Recruiting
    - Hospital Universitario Son Llatzer
    - Contact:
      
      Principal Investigator
  - Pamplona, Spain, 31008
    - Recruiting
    - Hospital Universitario de Navarra
    - Contact:
      
      Principal Investigator
  - Pamplona, Spain, 31008
    - Recruiting
    - Clinica Universidad de Navarra
    - Contact:
      
      Principal Investigator
  - Santa Cruz de Tenerife, Spain, 38320
    - Recruiting
    - Hospital Universitario de Canarias
    - Contact:
      
      Principal Investigator
  - Segovia, Spain, 40002
    - Recruiting
    - Hospital de Segovia
    - Contact:
      
      Principal Investigator
  - Toledo, Spain, 45007
    - Active, not recruiting
    - Hospital General Universitario de Toledo
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital la Fé
    - Contact:
      
      Principal Investigator
  - Valencia, Spain, 46010
    - Active, not recruiting
    - H. Clínico Univ. De Valencia
  - Valencia, Spain, 46014
    - Recruiting
    - Consorcio Hospital General Univ de Valencia
    - Contact:
      
      Principal Investigator
  - Vitoria-Gasteiz, Spain, 01009
    - Recruiting
    - Hospital Universitario de Alava
    - Contact:
      
      Principal Investigator
  - Zaragoza, Spain, 50009
    - Active, not recruiting
    - Hospital Clinico Universitaro Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Prospective data from routine clinical practice will be collected over the course of 1 year involving approximately 2000 patients across approximately 200 sites in Europe (Germany, Italy, Spain, Austria, and Belgium) treated by both specialized and non-specialized physicians in hospital and office-based settings.

Description

Key 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

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Bempedoic acid No drug was administered in this observational study. Drug: Ezetimibe No drug was administered in this observational study. Drug: Rosuvastatin No drug was administered in this observational study. Drug: Atorvastatin No drug was administered in this observational study.

Group / Cohort

Intervention / Treatment

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.

Drug: Bempedoic acid

No drug was administered in this observational study.

Drug: Ezetimibe

No drug was administered in this observational study.

Drug: Rosuvastatin

No drug was administered in this observational study.

Drug: Atorvastatin

No drug was administered in this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative LDL-C change between untreated and 8 week after triple therapy start Time Frame: Baseline to 8 weeks after initiation of triple therapy	LDL-C will be assessed using a standard lipid panel blood test,	Baseline to 8 weeks after initiation of triple therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year Time Frame: Baseline to 1 year after initiation of triple therapy	The 2019 EAS/ESC guidelines recommend treatment targets of at least a 50% reduction from baseline LDL-C levels and an LDL-C concentration below 1.8 mmol/L for patients at high and 1.4 mmol/l for patients at very high cardiovascular risk.	Baseline to 1 year after initiation of triple therapy
Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter Time Frame: Baseline to 1 year after initiation of triple therapy	Labs will be assessed using a standard panel blood test,	Baseline to 1 year after initiation of triple therapy
Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start Time Frame: Baseline to 1 year after initiation of triple therapy	Adherence will be judged by the physician/patient.	Baseline to 1 year after initiation of triple therapy
Incidence of adverse events under triple therapy exposure Time Frame: Baseline to 1 year after initiation of triple therapy	Adverse events are defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Baseline to 1 year after initiation of triple therapy
Proportion of patients with MACE-3 and MACE-4 events Time Frame: Baseline to 1 year after initiation of triple therapy	MACE-3 and MACE-4 events will consist of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only).	Baseline to 1 year after initiation of triple therapy
Relative LDL-C change between untreated and 1 year after triple therapy start Time Frame: From any prior LMT exposure to 1 year after initiation of triple therapy	LDL-C will be assessed using a standard lipid panel blood test,	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 Time Frame: From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy	LDL-C will be assessed using a standard lipid panel blood test,	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 Time Frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy	LDL-C will be assessed using a standard lipid panel blood test,	From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DSE-BMP-01-24-EU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Mixed Dyslipidemia

Clinical Trials on Bempedoic acid

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