A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
TRICONOS
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
1 other identifier
observational
2,000
5 countries
159
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 4, 2026
March 1, 2026
2.5 years
November 11, 2024
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative LDL-C change between untreated and 8 week after triple therapy start
LDL-C will be assessed using a standard lipid panel blood test,
Baseline to 8 weeks after initiation of triple therapy
Secondary Outcomes (8)
Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year
Baseline to 1 year after initiation of triple therapy
Relative LDL-C change between untreated and 1 year after triple therapy start
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
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
From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy
Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter
Baseline to 1 year after initiation of triple therapy
- +3 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
- \) 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (159)
Innere Medizin
Braunau am Inn, 5280, Austria
Innere Medizin 1
Feldkirch, 6800, Austria
Uniklinik Graz, Endokrinologie und Diabetes
Graz, 8036, Austria
Uniklinik Graz, Kardiologie
Graz, 8036, Austria
Innere Medizin 3 - Kardiologie
Innsbruck, 6020, Austria
Klinikum Wels-Grieskirchen GmbH+B18
Kepler Universitätsklinikum Gmb+, 4600, Austria
Innere Medizin
Klagenfurt, 9020, Austria
Innere Medizin
Linz, 4020, Austria
Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
Linz, 4021, Austria
Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
Linz, 4040, Austria
Ordination
Mattersburg, 7210, Austria
Landesklinikum Mistelbach - Gänserndorf
Mistelbach, 2130, Austria
Ordination Dr. med. univ. Evelyn Fließer-Görzer
Saint Stefan Bei Graz, 8511, Austria
Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)
Salzburg, 5020, Austria
DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen
Salzburg, 5026, Austria
Klinik Landstrasse, Kardiologie
Vienna, 1030, Austria
Ordination Univ.-Prof. Dr. Kurt Huber
Vienna, 1060, Austria
Zentrum für Klinische Studien Dr. Hanusch GmbH
Vienna, 1060, Austria
AKH Wien
Vienna, 1090, Austria
Meduni Wien, Endokrinologie und Diabetes
Vienna, 1090, Austria
Meduni Wien, Kardiologie
Vienna, 1090, Austria
Clinic Hietzing
Vienna, 1130, Austria
Herzzentrum 18
Vienna, 1180, Austria
Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf
Vienna, 1210, Austria
Azorg
Aalst, 9300, Belgium
UZA (Antwerp University Hospital)
Antwerp, 2650, Belgium
A.Z. KLINA Brasschaat
Brasschaat, 2930, Belgium
Algemeen Ziekenhuis Sint-Jan Oostende
Bruges, 8400, Belgium
CHU Brugman
Brussels, 1020, Belgium
CHU Charleroi Hopital civil Marie-Curie
Charleroi, 6042, Belgium
GHDC Charleroi - Site Hôpital Saint-Joseph
Charleroi, 6060, Belgium
Z.O.L - Campus St. Jan
Genk, 3600, Belgium
Az Sint Lucas
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
CHR Huy
Huy, 4500, Belgium
AZ Groeninge Kortrijk
Kortrijk, 8500, Belgium
Pôle hospitalier Jolimont
La Louvrière, 7100, Belgium
JAN YPERMAN Ziekenhuis
Leper, 8900, Belgium
CHR Citadelle de Liège
Liège, 4000, Belgium
AZ Delta
Roeselare, 8800, Belgium
AZ Glorieux
Ronse, 9600, Belgium
CHU UCL Mont-Godinne
Yvoir, 5530, Belgium
Praxis für Kardiologie Aachen
Aachen, 52062, Germany
Klinikum Ahaus
Ahaus, 48683, Germany
Praxis W. Almohamed
Alsfed, 36304, Germany
Zentrum für klinische Studien Bad Homburg
Bad Homburg, 61348, Germany
Dialysezentrum Hellersdorf Mitte
Berlin, 12627, Germany
Lipidambulanz Charite Campus Virchow
Berlin, 13353, Germany
MEDICLIN Reha-Zentrum Spreewald
Burg, 03096, Germany
Kardiologische Gemeinschaftspraxis Flemmingstr.
Chemnitz, 09116, Germany
Klinik Detmold
Detmold, 32756, Germany
Praxis Dr. Methfessel
Dresden, 01159, Germany
Cardiologicum Dresden
Dresden, 01796, Germany
Herz- und Gefäßmedizin Goslar
Goslar, 38640, Germany
ndgl.; viele Kombinationstherapien
Gräfenhainichen, 06773, Germany
Praxis
Greiz, 07973, Germany
Kardiologie am Tibarg
Hamburg, 22459, Germany
Jessa Ziekenhuis
Hasselt, 3500, Germany
HPK Heidelberger Praxisklinik
Heidelberg, 69115, Germany
Uni-Klinik Heidelberg
Heidelberg, 69120, Germany
Kardiopraxis
Kaiserslautern, 67655, Germany
GK Mittelrhein
Koblenz, 56073, Germany
Klinikum Konstanz
Konstanz, 78464, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
DRK Krankenhaus Lichtenstein Gemeinnützige GmbH
Lichtenstein, 09350, Germany
Cardio Centrum Ludwigsburg
Ludwigsburg, 71634, Germany
Kardiopraxis
Mainz, 55122, Germany
Kardiologische Praxis Markkleeberg
Markkleeberg, 04416, Germany
Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking
Moers, 47441, Germany
Praxis Dr. Norbert Schön
Mühldorf A. Inn, 84453, Germany
Kardiologische Gemeinschaftpraxis Papenburg
Papenburg, 26871, Germany
Kardiologische Gemeinschaftspraxis Papenburg
Papenburg, 26871, Germany
Hausärztlich-kardiologisches MVZ,,Am Felsenkeller" GmbH
Pirna, 01796, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, 14469, Germany
Lipidambulanz Uniklinikum Regensburg
Regensburg, 93053, Germany
Parkkardiologie, kard. Gemeinschaftspraxis
Stanhsdorf B. Berlin, 14532, Germany
BBT Trier
Trier, 54292, Germany
Diabetologische Schwerpunktpraxis
Trier, 54292, Germany
Herzklinik
Ulm, 89077, Germany
Dialysezentrum Hofaue
Wuppertal, 42103, Germany
Ente Ecclesiastico "Miulli"
Acquaviva delle Fonti, 70021, Italy
INRCA
Ancona, 60127, Italy
AO Moscati
Avellino, 83100, Italy
Osp. "San Paolo"
Bari, 70123, Italy
Ospedale di Bolzano
Bolzano, 39100, Italy
Spedali Civili di Brescia
Brescia, 25123, Italy
Osp. santo spirito
Casale Monferrato, 15033, Italy
Ospedale Sant'Anna e san Sebastiano
Caserta, 81100, Italy
Policlinnico Mater Domini
Catanzaro, 88100, Italy
Osp. SS Annunziata
Chieti, 66100, Italy
PO Nuovo Umberti I
Enna, 94100, Italy
Osp. Sant'Anna di Cona
Ferrara, 44124, Italy
Policlinico "Riuniti"
Foggia, 71122, Italy
Policlinico San Martino
Genova, 16132, Italy
Osp della Misericordia
Grosseto, 58100, Italy
Osp. "Vito Fazzi"
Lecce, 73100, Italy
Ospedale Mater Salutis
Legnagno, 37045, Italy
Spedali Riuniti
Livorno, 57124, Italy
Ospedale di Mantova
Mantova, 46100, Italy
Policlinico G. Martino
Messina, 98124, Italy
IRCCS Monzino
Milan, 20138, Italy
IRCCS Galeazzi Sant'Ambrogio
Milan, 20157, Italy
Policlinico Modena
Modena, 41125, Italy
AO Cardarelli
Naples, 80131, Italy
Policlinico Federico II
Naples, 80131, Italy
AOU Vanvitelli, I Policlinico
Naples, 80138, Italy
Policlinico P. Giaccone
Palermo, 90127, Italy
ICS Maugeri
Pavi, 27100, Italy
S. Maria della Misericordia
Perugia, 06129, Italy
Presidio Ospedaliero
Pescara, 65124, Italy
Ospedale PederzoliItlit
Peschiera, 37019, Italy
Cisanello
Pisa, 56124, Italy
Osp. Santa Maria delle Croci
Ravenna, 48121, Italy
Osp infermi di rivoli
Rivoli, 10098, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Ospedale Pertini
Roma, 00157, Italy
Ospedale Sant'Andrea
Roma, 00189, Italy
Policlinico Umberto I
Rome, 00161, Italy
Molinette Università to
Torino, 10126, Italy
Ospedale Mauriziano
Torino, 10128, Italy
Osp. di Cattinara
Trieste, 34149, Italy
Ospedale di Portogruaro
Venezia, 30026, Italy
AOUI Verona
Verona, 37126, Italy
H. Univers. De Albacete
Albacete, 02006, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
H. General de Elche
Alicante, 03203, Spain
Hospital Universitario de San Juan
Alicante, 03550, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
H. Univ. Puerta del Mar
Cadiz, 11009, Spain
H. Punta de Europa
Cadiz, 11207, Spain
Hospital Universitario Puerto Real
Cadiz, 11510, Spain
Sierrallana Hospital
Cantabria, 39300, Spain
H. Univ. Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014, Spain
H. Univ. De Cabueñes
Gijón, 33394, Spain
H. Virgen de las Nieves
Granada, 18014, Spain
H. Juan Ramón Jiménez
Huelva, 21005, Spain
Hospital Universitario Médico-Quirúrgico de Jaén
Jaén, 23007, Spain
Hospital Universitario de Gran Canarias Dr. Negrín
Las Palmas de GC, 35010, Spain
Hospital de León
León, 24008, Spain
Hospital San Pedro
Logroño, 26006, Spain
H. Costa del Sol
Marbella (Málaga), 29603, Spain
H. Virgen de la Victoria
Málaga, 29010, Spain
Hospital Serranía de Ronda
Málaga, 29400, Spain
Hospital General Universitario Reina Sofía
Murcia, 30003, Spain
H. Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitario Son LLatzer
Palma de Mallorca, 07198, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital de Segovia
Segovia, 40002, Spain
Hospital General Universitario de Toledo
Toledo, 45007, Spain
H. Clínico Univ. De Valencia
Valencia, 46010, Spain
Consorcio Hospital General Univ de Valencia
Valencia, 46014, Spain
Hospital La Fe
Valencia, 46026, Spain
Hospital Universitario de Álava
Vitoria-Gasteiz, 01009, Spain
Hospital Clinico Universitaro Lozano Blesa
Zaragoza, 50009, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
November 13, 2024
Study Start
February 12, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share