Actively Recruiting
Effectiveness and Safety of Bempedoic Acid Combined With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study
Led by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Updated on 2026-05-08
2000
Participants Needed
163
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world use, effectiveness, and safety of triple therapy combining bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin in adults with primary hypercholesterolemia or mixed dyslipidemia. This observational study focuses on how well this combination lowers LDL cholesterol (LDL-C) and its safety when used in clinical practice, addressing the limited data currently available on such combination treatments. The study observes patients who have started triple therapy with bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin without administering any drugs as part of the trial. Participants will be followed for up to one year after beginning triple therapy. The study does not compare rosuvastatin and atorvastatin directly but assesses the overall impact of the triple therapy on LDL-C levels. Participants will have their LDL-C levels measured at 8 weeks and one year after starting triple therapy to evaluate effectiveness. Researchers will also track goal attainment based on guidelines, changes in laboratory values, adherence to therapy, and any adverse events. Cardiovascular events such as non-fatal heart attacks, strokes, and deaths will be monitored during the follow-up. Treatment changes and the patient journey over the year will also be recorded. The total participation time is up to one year after therapy initiation.
CONDITIONS
Brief Title
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent to participate
- At least 18 years of age
- High or very high risk patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment
- Treated with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin in any combination or simultaneously
- Initiated triple therapy within 4 weeks before inclusion
- Has an untreated LDL-C value available within 5 years before starting triple therapy
- No contraindications to bempedoic acid, statins, or ezetimibe as assessed by physician
- Not participating in any interventional study currently
- Life expectancy greater than 1 year
You will not qualify if you...
- Received PCSK9i monoclonal antibody treatment within 3 months before starting triple therapy
- Ever received PCSK9i-siRNA treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants who undergo routine care with triple therapy (bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin) are observed for effectiveness and safety outcomes.
Visits occur at baseline, 8 weeks, and 1 year after triple therapy initiation
Trial Site Locations
Total: 163 locations
1
Innere Medizin
Braunau am Inn, Austria, 5280
Actively Recruiting
2
Innere Medizin 1
Feldkirch, Austria, 6800
Actively Recruiting
3
Uniklinik Graz, Endokrinologie und Diabetes
Graz, Austria, 8036
Actively Recruiting
4
Uniklinik Graz, Kardiologie
Graz, Austria, 8036
Actively Recruiting
5
Innere Medizin 3 - Kardiologie
Innsbruck, Austria, 6020
Actively Recruiting
6
Klinikum Wels-Grieskirchen GmbH+B18
Kepler Universitätsklinikum Gmb+, Austria, 4600
Active, Not Recruiting
7
Innere Medizin
Klagenfurt, Austria, 9020
Actively Recruiting
8
Innere Medizin
Linz, Austria, 4020
Actively Recruiting
9
Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
Linz, Austria, 4021
Actively Recruiting
10
Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
Linz, Austria, 4040
Actively Recruiting
11
Ordination
Mattersburg, Austria, 7210
Actively Recruiting
12
Landesklinikum Mistelbach - Gänserndorf
Mistelbach, Austria, 2130
Active, Not Recruiting
13
Ordination Dr. med. univ. Evelyn Fließer-Görzer
Saint Stefan Bei Graz, Austria, 8511
Actively Recruiting
14
Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)
Salzburg, Austria, 5020
Actively Recruiting
15
DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen
Salzburg, Austria, 5026
Actively Recruiting
16
Klinik Landstrasse, Kardiologie
Vienna, Austria, 1030
Actively Recruiting
17
Ordination Univ.-Prof. Dr. Kurt Huber
Vienna, Austria, 1060
Active, Not Recruiting
18
Zentrum für Klinische Studien Dr. Hanusch GmbH
Vienna, Austria, 1060
Active, Not Recruiting
19
AKH Wien
Vienna, Austria, 1090
Actively Recruiting
20
Meduni Wien, Endokrinologie und Diabetes
Vienna, Austria, 1090
Actively Recruiting
21
Meduni Wien, Kardiologie
Vienna, Austria, 1090
Actively Recruiting
22
Clinic Hietzing
Vienna, Austria, 1130
Actively Recruiting
23
Herzzentrum 18
Vienna, Austria, 1180
Actively Recruiting
24
Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf
Vienna, Austria, 1210
Actively Recruiting
25
Azorg
Aalst, Belgium, 9300
Actively Recruiting
26
UZA (Antwerp University Hospital)
Antwerp, Belgium, 2650
Active, Not Recruiting
27
Epicure Hornu
Boussu, Belgium, 7301
Actively Recruiting
28
A.Z. KLINA Brasschaat
Brasschaat, Belgium, 2930
Actively Recruiting
29
Algemeen Ziekenhuis Sint-Jan Oostende
Bruges, Belgium, 8400
Actively Recruiting
30
CHU Brugman
Brussels, Belgium, 1020
Active, Not Recruiting
31
UZ Brussel
Brussels, Belgium, 1090
Active, Not Recruiting
32
CHU Charleroi Hopital civil Marie-Curie
Charleroi, Belgium, 6042
Actively Recruiting
33
GHDC Charleroi - Site Hôpital Saint-Joseph
Charleroi, Belgium, 6060
Actively Recruiting
34
Z.O.L - Campus St. Jan
Genk, Belgium, 3600
Actively Recruiting
35
Az Sint Lucas
Ghent, Belgium, 9000
Active, Not Recruiting
36
UZ Gent
Ghent, Belgium, 9000
Active, Not Recruiting
37
CHR Huy
Huy, Belgium, 4500
Active, Not Recruiting
38
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8500
Actively Recruiting
39
Pôle hospitalier Jolimont
La Louvrière, Belgium, 7100
Actively Recruiting
40
JAN YPERMAN Ziekenhuis
Leper, Belgium, 8900
Actively Recruiting
41
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
42
CHR Citadelle de Liège
Liège, Belgium, 4000
Active, Not Recruiting
43
CHU Mons Ambroise Paré
Mons, Belgium, 7000
Active, Not Recruiting
44
AZ Delta
Roeselare, Belgium, 8800
Actively Recruiting
45
AZ Glorieux
Ronse, Belgium, 9600
Actively Recruiting
46
CHU UCL Mont-Godinne
Yvoir, Belgium, 5530
Actively Recruiting
47
Praxis für Kardiologie Aachen
Aachen, Germany, 52062
Actively Recruiting
48
Klinikum Ahaus
Ahaus, Germany, 48683
Actively Recruiting
49
Praxis W. Almohamed
Alsfed, Germany, 36304
Actively Recruiting
50
Zentrum für klinische Studien Bad Homburg
Bad Homburg, Germany, 61348
Actively Recruiting
51
Dialysezentrum Hellersdorf Mitte
Berlin, Germany, 12627
Actively Recruiting
52
Lipidambulanz Charite Campus Virchow
Berlin, Germany, 13353
Actively Recruiting
53
MEDICLIN Reha-Zentrum Spreewald
Burg, Germany, 03096
Actively Recruiting
54
Kardiologische Gemeinschaftspraxis Flemmingstr.
Chemnitz, Germany, 09116
Actively Recruiting
55
Klinik Detmold
Detmold, Germany, 32756
Actively Recruiting
56
Praxis Dr. Methfessel
Dresden, Germany, 01159
Actively Recruiting
57
Cardiologicum Dresden
Dresden, Germany, 01796
Actively Recruiting
58
Herz- und Gefäßmedizin Goslar
Goslar, Germany, 38640
Actively Recruiting
59
ndgl.; viele Kombinationstherapien
Gräfenhainichen, Germany, 06773
Active, Not Recruiting
60
Praxis
Greiz, Germany, 07973
Actively Recruiting
61
Kardiologie am Tibarg
Hamburg, Germany, 22459
Actively Recruiting
62
Jessa Ziekenhuis
Hasselt, Germany, 3500
Actively Recruiting
63
HPK Heidelberger Praxisklinik
Heidelberg, Germany, 69115
Actively Recruiting
64
Uni-Klinik Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
65
Kardiopraxis
Kaiserslautern, Germany, 67655
Actively Recruiting
66
GK Mittelrhein
Koblenz, Germany, 56073
Actively Recruiting
67
Klinikum Konstanz
Konstanz, Germany, 78464
Actively Recruiting
68
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
69
DRK Krankenhaus Lichtenstein Gemeinnützige GmbH
Lichtenstein, Germany, 09350
Actively Recruiting
70
Cardio Centrum Ludwigsburg
Ludwigsburg, Germany, 71634
Actively Recruiting
71
Kardiopraxis
Mainz, Germany, 55122
Actively Recruiting
72
Kardiologische Praxis Markkleeberg
Markkleeberg, Germany, 04416
Actively Recruiting
73
Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking
Moers, Germany, 47441
Actively Recruiting
74
Praxis Dr. Norbert Schön
Mühldorf A. Inn, Germany, 84453
Actively Recruiting
75
Kardiologische Gemeinschaftpraxis Papenburg
Papenburg, Germany, 26871
Actively Recruiting
76
Kardiologische Gemeinschaftspraxis Papenburg
Papenburg, Germany, 26871
Actively Recruiting
77
Hausärztlich-kardiologisches MVZ,,Am Felsenkeller" GmbH
Pirna, Germany, 01796
Actively Recruiting
78
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Germany, 14469
Actively Recruiting
79
Lipidambulanz Uniklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
80
Parkkardiologie, kard. Gemeinschaftspraxis
Stanhsdorf B. Berlin, Germany, 14532
Actively Recruiting
81
BBT Trier
Trier, Germany, 54292
Active, Not Recruiting
82
Diabetologische Schwerpunktpraxis
Trier, Germany, 54292
Actively Recruiting
83
Herzklinik
Ulm, Germany, 89077
Actively Recruiting
84
Dialysezentrum Hofaue
Wuppertal, Germany, 42103
Active, Not Recruiting
85
Ente Ecclesiastico "Miulli"
Acquaviva delle Fonti, Italy, 70021
Actively Recruiting
86
INRCA
Ancona, Italy, 60127
Actively Recruiting
87
AO Moscati
Avellino, Italy, 83100
Actively Recruiting
88
Osp. "San Paolo"
Bari, Italy, 70123
Actively Recruiting
89
Ospedale di Bolzano
Bolzano, Italy, 39100
Actively Recruiting
90
Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
91
Osp. santo spirito
Casale Monferrato, Italy, 15033
Actively Recruiting
92
Ospedale Sant'Anna e san Sebastiano
Caserta, Italy, 81100
Actively Recruiting
93
Policlinnico Mater Domini
Catanzaro, Italy, 88100
Active, Not Recruiting
94
Osp. SS Annunziata
Chieti, Italy, 66100
Actively Recruiting
95
PO Nuovo Umberti I
Enna, Italy, 94100
Actively Recruiting
96
Osp. Sant'Anna di Cona
Ferrara, Italy, 44124
Actively Recruiting
97
Policlinico "Riuniti"
Foggia, Italy, 71122
Actively Recruiting
98
Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
99
Osp della Misericordia
Grosseto, Italy, 58100
Actively Recruiting
100
Osp. "Vito Fazzi"
Lecce, Italy, 73100
Actively Recruiting
101
Ospedale Mater Salutis
Legnagno, Italy, 37045
Actively Recruiting
102
Spedali Riuniti
Livorno, Italy, 57124
Actively Recruiting
103
Ospedale di Mantova
Mantua, Italy, 46100
Actively Recruiting
104
Policlinico G. Martino
Messina, Italy, 98124
Actively Recruiting
105
IRCCS Monzino
Milan, Italy, 20138
Actively Recruiting
106
IRCCS Galeazzi Sant'Ambrogio
Milan, Italy, 20157
Actively Recruiting
107
Policlinico Modena
Modena, Italy, 41125
Actively Recruiting
108
AO Cardarelli
Naples, Italy, 80131
Actively Recruiting
109
Policlinico Federico II
Naples, Italy, 80131
Actively Recruiting
110
AOU Vanvitelli, I Policlinico
Naples, Italy, 80138
Actively Recruiting
111
Policlinico P. Giaccone
Palermo, Italy, 90127
Actively Recruiting
112
ICS Maugeri
Pavi, Italy, 27100
Actively Recruiting
113
S. Maria della Misericordia
Perugia, Italy, 06129
Actively Recruiting
114
Presidio Ospedaliero
Pescara, Italy, 65124
Actively Recruiting
115
Ospedale PederzoliItlit
Peschiera, Italy, 37019
Actively Recruiting
116
Cisanello
Pisa, Italy, 56124
Actively Recruiting
117
Osp. Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
118
Osp infermi di rivoli
Rivoli, Italy, 10098
Actively Recruiting
119
Policlinico Tor Vergata
Roma, Italy, 00133
Actively Recruiting
120
Ospedale Pertini
Roma, Italy, 00157
Actively Recruiting
121
Ospedale Sant'Andrea
Roma, Italy, 00189
Actively Recruiting
122
Policlinico Umberto I
Rome, Italy, 00161
Actively Recruiting
123
Molinette Università to
Torino, Italy, 10126
Actively Recruiting
124
Ospedale Mauriziano
Torino, Italy, 10128
Actively Recruiting
125
Osp. di Cattinara
Trieste, Italy, 34149
Actively Recruiting
126
Ospedale di Portogruaro
Venezia, Italy, 30026
Actively Recruiting
127
AOUI Verona
Verona, Italy, 37126
Actively Recruiting
128
H. Univers. De Albacete
Albacete, Spain, 02006
Actively Recruiting
129
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
130
H. General de Elche
Alicante, Spain, 03203
Actively Recruiting
131
Hospital Universitario de San Juan
Alicante, Spain, 03550
Actively Recruiting
132
Hospital Universitario de Cruces
Barakaldo, Spain, 48903
Actively Recruiting
133
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
134
H. Univ. Puerta del Mar
Cadiz, Spain, 11009
Actively Recruiting
135
H. Punta de Europa
Cadiz, Spain, 11207
Actively Recruiting
136
Hospital Universitario Puerto Real
Cadiz, Spain, 11510
Actively Recruiting
137
Sierrallana Hospital
Cantabria, Spain, 39300
Actively Recruiting
138
H. Univ. Reina Sofía
Córdoba, Spain, 14004
Active, Not Recruiting
139
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain, 20014
Active, Not Recruiting
140
H. Univ. De Cabueñes
Gijón, Spain, 33394
Actively Recruiting
141
H. Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
142
H. Juan Ramón Jiménez
Huelva, Spain, 21005
Actively Recruiting
143
Hospital Universitario Médico-Quirúrgico de Jaén
Jaén, Spain, 23007
Actively Recruiting
144
Hospital Universitario de Gran Canarias Dr. Negrín
Las Palmas de GC, Spain, 35010
Actively Recruiting
145
Hospital de León
León, Spain, 24008
Actively Recruiting
146
Hospital San Pedro
Logroño, Spain, 26006
Actively Recruiting
147
H. Costa del Sol
Marbella (Málaga), Spain, 29603
Actively Recruiting
148
H. Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
149
Hospital Serranía de Ronda
Málaga, Spain, 29400
Actively Recruiting
150
Hospital General Universitario Reina Sofía
Murcia, Spain, 30003
Active, Not Recruiting
151
H. Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
152
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
153
Hospital Universitario Son LLatzer
Palma de Mallorca, Spain, 07198
Actively Recruiting
154
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
155
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
156
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320
Actively Recruiting
157
Hospital de Segovia
Segovia, Spain, 40002
Actively Recruiting
158
Hospital General Universitario de Toledo
Toledo, Spain, 45007
Active, Not Recruiting
159
H. Clínico Univ. De Valencia
Valencia, Spain, 46010
Active, Not Recruiting
160
Consorcio Hospital General Univ de Valencia
Valencia, Spain, 46014
Actively Recruiting
161
Hospital La Fe
Valencia, Spain, 46026
Actively Recruiting
162
Hospital Universitario de Álava
Vitoria-Gasteiz, Spain, 01009
Actively Recruiting
163
Hospital Clinico Universitaro Lozano Blesa
Zaragoza, Spain, 50009
Active, Not Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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