Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS)

Non-interventional Study on the Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS)

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C).

Secondary objectives are to document and evaluate as applicable:

  • Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. Systematic Coronary Risk Estimation (SCORE) system, SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only).
  • Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp[a]) compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe.
  • Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Relevant CV events:

    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery (CABG)
    • Percutaneous transluminal coronary angioplasty (PTCA)
    • Stroke
    • Transient ischemic attack (TIA)
    • Acute peripheral arterial occlusion
    • All-cause death
    • Cardiovascular (CV)-death
  • Adverse effects associated with lipid-modifying treatment (LMT)

    • Laboratory abnormalities
    • Muscle-associated symptoms
    • New onset and/or worsening diabetes
    • Changes in the patients´ glycemic status over time
  • Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe.
  • Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments).
  • Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions).
  • Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.

Study Overview

Detailed Description

This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.

Study Type

Observational

Enrollment (Estimated)

5000

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: 908-992-6400
  • Email: CTRinfo@dsi.com

Study Locations

      • Dornbirn, Austria, 6850
        • Recruiting
        • Dr. Armin Öhlinger Kardiologe & innere Medizin
        • Contact:
          • Principal Investigator
      • Feldkirch, Austria, 6807
        • Recruiting
        • Landeskrankenhaus Feldkirch
        • Contact:
          • Principal Investigator
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz
        • Contact:
          • Principal Investigator
      • Graz, Austria, 8036
        • Recruiting
        • LKH-Univ. Klinikum Graz
        • Contact:
          • Principal Investigator
      • Graz, Austria, 8020
        • Recruiting
        • Institut für Herz- und Gefäßerkrankungen GmbH
        • Contact:
          • Principal Investigator
      • Horsching, Austria, 4063
        • Recruiting
        • Internist Dr. med. univ. Stefan Moser
        • Contact:
          • Principal Investigator
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universität Innsbruck
        • Contact:
          • Principal Investigator
      • Klagenfurt am Worthersee, Austria, 9020
        • Recruiting
        • KABEG Klinikum Klagenfurt am Wörthersee
        • Contact:
          • Principal Investigator
      • Linz, Austria, 4020
        • Recruiting
        • Konventhospital der Barmherzigen Brüder Linz
        • Contact:
          • Principal Investigator
      • Linz, Austria, 4040
        • Recruiting
        • Ordination Dr. Johannes Föchterle
        • Contact:
          • Principal Investigator
      • Mattersburg, Austria, 7210
        • Recruiting
        • Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl
        • Contact:
          • Principal Investigator
      • Melk, Austria, 3390
        • Recruiting
        • Landesklinikum Melk
        • Contact:
          • Principal Investigator
      • Salzburg, Austria, 5026
        • Recruiting
        • Kompetenz-Zentrum Diabetes
        • Contact:
          • Principal Investigator
      • Sankt Aegyd Am Neuwalde, Austria, 3193
        • Recruiting
        • Ordination Universitätsdozent Dr. Alexander Kober
        • Contact:
          • Principal Investigator
      • Sankt Stefan Ob Stainz, Austria, 8511
        • Recruiting
        • Ordination Dr. med. univ. Evelyn Fließer-Görzer
        • Contact:
          • Principal Investigator
      • Villach, Austria, 9500
        • Recruiting
        • Landeskrankenhaus Villach
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1010
        • Recruiting
        • Ordination Dr. Thomas Maca
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1030
        • Recruiting
        • Klinik Hietzing, Wiener Gesundheitsverbund
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1060
        • Recruiting
        • Zentrum für Klinische Studien Dr. Hanusch GmbH
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1090
        • Recruiting
        • Allgemeines Krankenhaus Der Stadt Wien
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1180
        • Recruiting
        • Herz Zentrum Währing
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1210
        • Recruiting
        • Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1230
        • Recruiting
        • Schnürer & Fritsch - Gruppenpraxis für Innere Medizin
        • Contact:
          • Principal Investigator
      • Aalst, Belgium, 9300
        • Recruiting
        • ASZ
        • Contact:
          • Principal Investigator
      • Boussu, Belgium, B-7301
        • Recruiting
        • Epicura Hornu
        • Contact:
          • Principal Investigator
      • Brasschaat, Belgium, B-2930
        • Recruiting
        • A.Z. KLINA Brasschaat
        • Contact:
          • Principal Investigator
      • Bruxelles, Belgium, B-1000
        • Recruiting
        • Clinique Saint-Jean Bruxelles
        • Contact:
          • Principal Investigator
      • Bruxelles, Belgium, B-1020
        • Not yet recruiting
        • CHU Brugman
        • Contact:
          • Principal Investigator
      • Bruxelles, Belgium, B-1070
        • Not yet recruiting
        • CUB-Hôpital Erasme
        • Contact:
          • Principal Investigator
      • Bruxelles, Belgium, B-1090
        • Recruiting
        • UZ Brussel
        • Contact:
          • Principal Investigator
      • Bruxelles, Belgium, B-1180
        • Recruiting
        • Clinique de l'Europe Saint Elisabeth
        • Contact:
          • Principal Investigator
      • Bruxelles, Belgium, B-1200
        • Recruiting
        • UCL Saint-Luc Woluwé Bruxelles
        • Contact:
          • Principal Investigator
      • Ciney, Belgium, B-5590
        • Not yet recruiting
        • Private Practice
        • Contact:
          • Principal Investigator
      • Dendermonde, Belgium, 9200
        • Not yet recruiting
        • Az Sint Blazius
        • Contact:
          • Principal Investigator
      • Edegem, Belgium, B-2650
        • Not yet recruiting
        • UZ Antwerpen
        • Contact:
          • Principal Investigator
      • Genk, Belgium, B-3600
        • Recruiting
        • Z.O.L - Campus St. Jan
        • Contact:
          • Principal Investigator
      • Ghent, Belgium, B-9000
        • Recruiting
        • AZ St-Lucas & Volkskliniek
        • Contact:
          • Principal Investigator
      • Ghent, Belgium, B-9000
        • Recruiting
        • UZ Gent
        • Contact:
          • Principal Investigator
      • Gilly, Belgium, B-6060
        • Recruiting
        • GHDC Charleroi - Site Hôpital Saint-Joseph
        • Contact:
          • Principal Investigator
      • Gribomont, Belgium, B-6887
        • Recruiting
        • Private Practice
        • Contact:
          • Principal Investigator
      • Haine-Saint-Paul, Belgium, B-7100
        • Recruiting
        • Pôle Hospitalier Jolimont
        • Contact:
          • Principal Investigator
      • Halen, Belgium, B-3545
        • Recruiting
        • BVBA Med Kab
        • Contact:
          • Principal Investigator
      • Hasselt, Belgium, B-3500
        • Recruiting
        • Jessa Ziekenhuis
        • Contact:
          • Principal Investigator
      • Huy, Belgium, B-4500
        • Recruiting
        • CHR Huy
        • Contact:
          • Principal Investigator
      • Ieper, Belgium, B-9800
        • Recruiting
        • Jan Yperman ziekenhuis
        • Contact:
          • Principal Investigator
      • Kortrijk, Belgium, B-8500
        • Recruiting
        • AZ Groeninge Kortrijk
        • Contact:
          • Principal Investigator
      • La Louvière, Belgium, B-7100
        • Not yet recruiting
        • Chu Tivoli
        • Contact:
          • Principal Investigator
      • Leuven, Belgium, B-3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Principal Investigator
      • Liège, Belgium, B-4000
        • Recruiting
        • CHR Citadelle de Liège
        • Contact:
          • Principal Investigator
      • Lodelinsart, Belgium, B-6042
        • Recruiting
        • CHU Charleroi Hopital civil Marie-Curie
        • Contact:
          • Principal Investigator
      • Mons, Belgium, B-7000
        • Recruiting
        • CHU Mons Ambroise Paré
        • Contact:
          • Principal Investigator
      • Oostende, Belgium, B-8400
        • Recruiting
        • AZ Sint Jan
        • Contact:
          • Principal Investigator
      • Roeselare, Belgium, B-8800
        • Recruiting
        • AZ Delta
        • Contact:
          • Principal Investigator
      • Ronse, Belgium, B-9600
        • Recruiting
        • AZ Glorieux
        • Contact:
          • Principal Investigator
      • Sint Truiden, Belgium, B-3800
        • Recruiting
        • Sint Trudo
        • Contact:
          • Principal Investigator
      • Tielt, Belgium, B-8700
        • Recruiting
        • Sint-Andriesziekenhuis Tielt
        • Contact:
          • Principal Investigator
      • Tienen, Belgium, B-3300
        • Not yet recruiting
        • Private Practice
        • Contact:
          • Principal Investigator
      • Yvoir, Belgium, B-5530
        • Recruiting
        • CHU UCL Mont-Godinne
        • Contact:
          • Principal Investigator
      • Aue, Germany, 08280
        • Active, not recruiting
        • MVZ Helios Aue
      • Bad Elster, Germany, 08645
        • Active, not recruiting
        • Kardiologische Praxis Enders
      • Bad Homburg, Germany, 61348
        • Active, not recruiting
        • Kardiologische Praxis
      • Bad Krozingen, Germany, 79189
        • Active, not recruiting
        • Universitätsklinikum Freiburg - Universitäts-Herzzentrum
      • Bad Segeberg, Germany, 23795
        • Active, not recruiting
        • Praxis am Landratspark
      • Bamberg, Germany, 96049
        • Active, not recruiting
        • CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel
      • Bechhofen, Germany, 66894
        • Active, not recruiting
        • Kardiologische Praxis
      • Berlin, Germany, 12203
        • Active, not recruiting
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10789
        • Active, not recruiting
        • Praxis Rankestraße
      • Berlin, Germany, 12165
        • Active, not recruiting
        • Herzpraxis Berlin MVZ
      • Berlin, Germany, 12627
        • Active, not recruiting
        • Dres. Seeger & Partner
      • Berlin, Germany, 13187
        • Active, not recruiting
        • Diabetespraxis Dr. Braun
      • Berlin, Germany, 13353
        • Active, not recruiting
        • Lipidambulanz Charite
      • Biedenkopf, Germany, 35216
        • Active, not recruiting
        • Praxiszentrum Biedenkopf
      • Blankenhain, Germany, 99444
        • Active, not recruiting
        • Praxis Dr. A. Biedermann
      • Bonn, Germany, 53173
        • Active, not recruiting
        • MVZ für Innere Medizin
      • Bruchsal, Germany, 76646
        • Active, not recruiting
        • Kardiologie im Friedrichspalast Bruchsal
      • Bunde, Germany, 32257
        • Active, not recruiting
        • Studiengesellschaft Könemann und Steinmann GbR
      • Burg, Germany, 03096
        • Active, not recruiting
        • MediClin Reha-Zentrum Spreewald
      • Chemnitz, Germany, 09113
        • Active, not recruiting
        • MVZ am Küchwald
      • Chemnitz, Germany, 09126
        • Active, not recruiting
        • Kardiologische Praxis Stellmach
      • Chemnitz, Germany, 09130
        • Active, not recruiting
        • MVZ Polymed
      • Dessau, Germany, 06846
        • Active, not recruiting
        • Praxis Dr. Menzel
      • Detmold, Germany, 32756
        • Active, not recruiting
        • Klinikum Lippe GmbH
      • Dortmund, Germany, 44137
        • Active, not recruiting
        • Kardiologische Gemeinschaftspraxis
      • Dresden, Germany, 01277
        • Active, not recruiting
        • Cardiologicum Dresden/Pirna
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Dres. Günther/Kolschmann
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Universitätsklinikum Carl Gustav Carus
      • Duisburg, Germany, 47051
        • Active, not recruiting
        • DZDM Diabeteszentrum Duisburg Mitte
      • Düren, Germany, 52351
        • Active, not recruiting
        • Nierenzentrum Düren
      • Düsseldorf, Germany, 40225
        • Active, not recruiting
        • Universitätsklinikum Düsseldorf
      • Ehringshausen, Germany, 35630
        • Terminated
        • Praxis Dilltal
      • Eisenach, Germany, 99817
        • Active, not recruiting
        • Praxis Dipl. -Med. Petra Herrmann
      • Elsterwerda, Germany, 04910
        • Active, not recruiting
        • Kardiologische Praxis
      • Erlangen, Germany, 91052
        • Active, not recruiting
        • Gemeinschaftspraxis ISP Erlangen
      • Essen, Germany, 45355
        • Active, not recruiting
        • Hausarztzentrum am Germaniaplatz
      • Flensburg, Germany, 24939
        • Active, not recruiting
        • DIAKO Flensburg
      • Flensburg, Germany, 24941
        • Active, not recruiting
        • Praxis für Nieren und Hochdruck-Krankheiten
      • Fulda, Germany, 36037
        • Active, not recruiting
        • MVZ Altstadt-Carree Fulda
      • Gera, Germany, 07551
        • Active, not recruiting
        • Praxis Dr. Langel
      • Greifswald, Germany, 17475
        • Active, not recruiting
        • Universitätsmedizin Greifswald
      • Gräfenhainichen, Germany, 06773
        • Active, not recruiting
        • Praxis Dr. Müller
      • Görlitz, Germany, 02827
        • Active, not recruiting
        • Praxis für Gefäßmedizin
      • Göttingen, Germany, 37075
        • Active, not recruiting
        • Universitatsmedizin Gottingen
      • Hagen, Germany, 58135
        • Active, not recruiting
        • Evangelisches Krankenhaus Hagen-Haspe
      • Hainburg, Germany, 63512
        • Active, not recruiting
        • Praxis
      • Hamburg, Germany, 22041
        • Active, not recruiting
        • Cardiologicum Hamburg - Praxis Wandsbek
      • Hamburg, Germany, 22041
        • Active, not recruiting
        • Diabetes Zentrum Wandsbeck
      • Hamburg, Germany, 22527
        • Active, not recruiting
        • MVZ Prof. Mathey, Prof. Schofer
      • Hamburg, Germany, 22549
        • Active, not recruiting
        • Kardiologie am Tibarg
      • Hannover, Germany, 30177
        • Active, not recruiting
        • Kardiologie List
      • Haßloch, Germany, 67454
        • Active, not recruiting
        • Kardiologische Praxis
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • UniversitatsKlinikum Heidelberg
      • Heidelberg, Germany, 69115
        • Active, not recruiting
        • Kardiologische Schwerpunktpraxis
      • Heiligenstadt, Germany, 37308
        • Active, not recruiting
        • Praxis Heik/Wedig
      • Ingolstadt, Germany, 85049
        • Active, not recruiting
        • KARDIO-IN Kardiologische Gemeinschaftspraxis
      • Kaiserslautern, Germany, 67655
        • Active, not recruiting
        • Kardiologische Praxis
      • Karlsbad, Germany, 76307
        • Active, not recruiting
        • SRH Klinikum Karlsbad-Langensteinbach
      • Kassel, Germany, 34121
        • Active, not recruiting
        • B. Braun Ambulantes Herzzentrum Kassel
      • Katzhütte, Germany, 98746
        • Active, not recruiting
        • Praxis Dr. Heiner Müller
      • Kiel, Germany, 24106
        • Active, not recruiting
        • Nephrologie Kiel
      • Koblenz, Germany, 56068
        • Active, not recruiting
        • Gemeinschaftsklinikum Mittelrhein
      • Konstanz, Germany, 78464
        • Active, not recruiting
        • Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz
      • Kornwestheim, Germany, 70806
        • Active, not recruiting
        • Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann
      • Kyritz, Germany, 16866
        • Active, not recruiting
        • Kardiologische Praxis Kyritz
      • Köln, Germany, 51069
        • Active, not recruiting
        • Zentrum für klinische Forschung
      • Köln, Germany, 51105
        • Active, not recruiting
        • IKAPP
      • Leipzig, Germany, 04103
        • Active, not recruiting
        • Universitätsklinikum Leipzig
      • Leipzig, Germany, 04129
        • Active, not recruiting
        • Kardiologische Praxis Boudriot
      • Leipzig, Germany, 04317
        • Active, not recruiting
        • MVZ Stoffwechselmedizin Leipzig
      • Lichtenfels, Germany, 96215
        • Active, not recruiting
        • Praxis Dr. I.Simon-Wagner
      • Limburg, Germany, 65549
        • Active, not recruiting
        • St. Vincenz Krankenhaus
      • Lohne, Germany, 32584
        • Active, not recruiting
        • Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet
      • Ludwigsburg, Germany, 71634
        • Active, not recruiting
        • Cardio Centrum Ludwigsburg-Bietigheim
      • Ludwigshafen, Germany, 67071
        • Active, not recruiting
        • Kardiologische Praxisklinik Ludwigshafen
      • Luebeck, Germany, 23538
        • Active, not recruiting
        • Universität zu Lübeck
      • Lutherstadt Wittenberg, Germany, 06886
        • Active, not recruiting
        • Kardiologische Praxis Tamm/Hoh
      • Magdeburg, Germany, 39110
        • Active, not recruiting
        • Institut für Präventive Medizin & Klinische Forschung GbR
      • Mainz, Germany, 55122
        • Active, not recruiting
        • Cardiopraxis Mainz
      • Mainz, Germany, 55131
        • Active, not recruiting
        • Katholisches Klinikum Mainz
      • Mainz, Germany, 55131
        • Active, not recruiting
        • Universitätsklinikum Mainz
      • Mannheim, Germany, 68165
        • Active, not recruiting
        • ZE:RO Praxen
      • Mannheim, Germany, 68167
        • Active, not recruiting
        • UMM Mannheim
      • Markkleeberg, Germany, 04416
        • Active, not recruiting
        • Kardiologische Praxis
      • Meiningen, Germany, 98617
        • Active, not recruiting
        • Praxis Ben-Chur
      • Moers, Germany, 47441
        • Recruiting
        • Praxis Haj-Yehia
        • Contact:
          • Principal Investigator
      • Mühldorf, Germany, 84453
        • Active, not recruiting
        • Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte
      • Mühldorf, Germany, 84453
        • Active, not recruiting
        • Kardiologie Mühldorf am Inn
      • Mülheim an der Ruhr, Germany, 45468
        • Active, not recruiting
        • Herzquartier Mülheim
      • München, Germany, 80634
        • Active, not recruiting
        • Kardiologie Neuhausen-Nymphenburg
      • München, Germany, 80799
        • Active, not recruiting
        • Dres. Wauer/Windstetter
      • Münster, Germany, 48149
        • Active, not recruiting
        • Universitätsklinikum Münster
      • Münster, Germany, 48143
        • Active, not recruiting
        • Praxis Kiepenkerl
      • Münster, Germany, 48143
        • Active, not recruiting
        • Zentrum für Kardiologie an der Raphaelsklinik Münster
      • Münster, Germany, 48149
        • Active, not recruiting
        • Praxis für Innere Medizin Münster
      • Neu Isenburg, Germany, 63263
        • Active, not recruiting
        • Internistische Praxisgemeinschaft
      • Oer-Erkenschwick, Germany, 45739
        • Active, not recruiting
        • Hausarztpraxis
      • Paderborn, Germany, 33098
        • Active, not recruiting
        • St. Vincenz-Krankenhaus GmbH
      • Papenburg, Germany, 26871
        • Active, not recruiting
        • Kardiologische Praxis Papenburg - Site 6071
      • Papenburg, Germany, 26871
        • Active, not recruiting
        • Kardiologische Praxis Papenburg - Site 6072
      • Passau, Germany, 94032
        • Active, not recruiting
        • Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan
      • Pirna, Germany, 01796
        • Active, not recruiting
        • Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH
      • Potsdam, Germany, 14469
        • Active, not recruiting
        • VieSante Herzmedizin Potsdam
      • Potsdam, Germany, 14471
        • Active, not recruiting
        • Kardiologische Gemeinschaftspraxis
      • Radebeul, Germany, 01445
        • Active, not recruiting
        • Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann
      • Riesa, Germany, 01587
        • Active, not recruiting
        • Gemeinschaftspraxis Herz Riesa
      • Rostock, Germany, 18057
        • Active, not recruiting
        • Universitätsmedizin Rostock
      • Schwerin, Germany, 19057
        • Active, not recruiting
        • MVZ Schwerin West GmbH
      • Schwäbisch Hall, Germany, 74523
        • Active, not recruiting
        • Facharztpraxis für Kardiologie und Innere Medizin
      • Singen, Germany, 78224
        • Active, not recruiting
        • Klinik Singen
      • Sonneberg, Germany, 96515
        • Active, not recruiting
        • MEDINOS Klinik Sonneberg
      • Straubing, Germany, 94315
        • Active, not recruiting
        • Kardiologische Praxis im Steiner Thor
      • Straubing, Germany, 94315
        • Active, not recruiting
        • Praxis Dr Knöbel u. Partner
      • Strausberg, Germany, 15344
        • Active, not recruiting
        • Praxis Dr. Michael Rother
      • Trier, Germany, 54292
        • Active, not recruiting
        • Diabetologische Schwerpunktpraxis
      • Trier, Germany, 54292
        • Active, not recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
      • Ulm, Germany, 89077
        • Active, not recruiting
        • Studienzentrum der Herzklinik Ulm GbR
      • Unterwellenborn, Germany, 07333
        • Active, not recruiting
        • Praxis Dr. Hansen
      • Völklingen, Germany, 66333
        • Active, not recruiting
        • Herzzentrum Saar
      • Weinheim, Germany, 69469
        • Active, not recruiting
        • GRN Weinheim
      • Wermsdorf, Germany, 04779
        • Active, not recruiting
        • Kardiologische Praxis Al-Zoebi
      • Weyhe, Germany, 28844
        • Active, not recruiting
        • Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße
      • Wolmirstedt, Germany, 39326
        • Active, not recruiting
        • Kardiologische Fachpraxis
      • Wuppertal, Germany, 42103
        • Active, not recruiting
        • Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue
      • Würzburg, Germany, 97080
        • Active, not recruiting
        • Universitatsklinikum Wurzburg
      • Zwiesel, Germany, 94227
        • Active, not recruiting
        • Gemeinschaftspraxis am Angerbrunnen
      • Acquaviva Delle Fonti, Italy, 70021
        • Active, not recruiting
        • Ospedale Generale Regionale "F. Miulli"
      • Agrigento, Italy, 92100
        • Not yet recruiting
        • P.O. Agrigento Ospedale San Giovanni di Dio
        • Contact:
          • Principal Investigator
      • Ancona, Italy, 60127
        • Recruiting
        • IRCCS-INRCA Ancona
        • Contact:
          • Principal Investigator
      • Anzio, Italy, 00042
        • Not yet recruiting
        • Ospedale di Anzio
        • Contact:
          • Principal Investigator
      • Ariccia, Italy, 00072
        • Not yet recruiting
        • Ospedale dei Castelli
        • Contact:
          • Principal Investigator
      • Ascoli Piceno, Italy, 63100
        • Recruiting
        • Ospedale "C. e G. Mazzoni"
        • Contact:
          • Principal Investigator
      • Augusta, Italy, 96011
        • Not yet recruiting
        • P.O. ''E. Muscatello''
        • Contact:
          • Principal Investigator
      • Avellino, Italy, 83100
        • Not yet recruiting
        • A.O. San Giuseppe Moscati
        • Contact:
          • Principal Investigator
      • Avezzano, Italy, 67051
        • Not yet recruiting
        • Ospedale SS Nicola e Filippo
        • Contact:
          • Principal Investigator
      • Bari, Italy, 70123
        • Not yet recruiting
        • Ospedale S. Paolo
        • Contact:
          • Principal Investigator
      • Bari, Italy, 70124
        • Not yet recruiting
        • A.O.U. Consorziale - Policlinico Bari
        • Contact:
          • Principal Investigator
      • Bari, Italy, 70124
        • Not yet recruiting
        • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08016
        • Contact:
          • Principal Investigator
      • Bari, Italy, 70124
        • Not yet recruiting
        • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08017
        • Contact:
          • Principal Investigator
      • Benevento, Italy, 82100
        • Not yet recruiting
        • Azienda Ospedaliera S. Pio presidio G. Rummo
        • Contact:
          • Principal Investigator
      • Bentivoglio, Italy, 40010
        • Not yet recruiting
        • AUSL Bologna Ospedale di Bentivoglio
        • Contact:
          • Principal Investigator
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • ASST Papa Giovanni XXIII
        • Contact:
          • Principal Investigator
      • Bologna, Italy, 40133
        • Not yet recruiting
        • Ospedale Maggiore Carlo Alberto Pizzardi
        • Contact:
          • Principal Investigator
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Policlinico Sant'Orsola Bologna-Malpighi
        • Contact:
          • Principal Investigator
      • Bolzano, Italy, 39100
        • Not yet recruiting
        • Ospedale di Bolzano - Site 08070
        • Contact:
          • Principal Investigator
      • Bolzano, Italy, 39100
        • Active, not recruiting
        • Ospedale di Bolzano - Site 08112
      • Brescia, Italy, 25123
        • Recruiting
        • Spedali Civili di Brescia
        • Contact:
          • Principal Investigator
      • Cagliari, Italy, 09126
        • Not yet recruiting
        • ASSL Cagliari Ospedale Binaghi
        • Contact:
          • Principal Investigator
      • Casale Monferrato, Italy, 15033
        • Not yet recruiting
        • Ospedale Santo Spirito Casale Monferrato
        • Contact:
          • Principal Investigator
      • Caserta, Italy, 81100
        • Active, not recruiting
        • A.O. S. Anna e S. Sebastiano
      • Castelfranco Veneto, Italy, 31033
        • Not yet recruiting
        • ULLS 2 MARCA TREVIGIANA Ospedale di Castelfranco Veneto
        • Contact:
          • Principal Investigator
      • Catania, Italy, 95124
        • Active, not recruiting
        • AOU Policlinico Vittorio Emanuele Presidio Ospedaliero Gaspare Rodolico
      • Catania, Italy, 95126
        • Active, not recruiting
        • Azienda Ospedaliera Cannizzaro
      • Catanzaro, Italy, 88100
        • Not yet recruiting
        • L'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
        • Contact:
          • Principal Investigator
      • Cava Dè Tirreni, Italy, 84013
        • Not yet recruiting
        • Ospedale Civile Santa Maria Incoronata dell'Olmo
        • Contact:
          • Principal Investigator
      • Chieti, Italy, 66100
        • Not yet recruiting
        • Policlinico SS. Annunziata
        • Contact:
          • Principal Investigator
      • Ciriè, Italy, 10073
        • Not yet recruiting
        • ASL TO4 Presidio Riunito di Ciriè-Lanzo
        • Contact:
          • Principal Investigator
      • Cona, Italy, 44124
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara "Arcispedale Sant'Anna"
        • Contact:
          • Principal Investigator
      • Coppito, Italy, 67100
        • Not yet recruiting
        • Ospedale San Salvatore
        • Contact:
          • Principal Investigator
      • Cremona, Italy, 26100
        • Not yet recruiting
        • ASST Cremona - Ospedale di Cremona
        • Contact:
          • Principal Investigator
      • Firenze, Italy, 50122
        • Not yet recruiting
        • Ospedale Santa Maria Nuova
        • Contact:
          • Principal Investigator
      • Firenze, Italy, 50134
        • Not yet recruiting
        • AOU Careggi - Site 08067
        • Contact:
          • Principal Investigator
      • Firenze, Italy, 50134
        • Not yet recruiting
        • AOU Careggi - Site 08081
        • Contact:
          • Principal Investigator
      • Firenze, Italy, 50134
        • Not yet recruiting
        • AOU Careggi - Site 08090
        • Contact:
          • Principal Investigator
      • Foggia, Italy, 71122
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria "Ospedali Riuniti" di Foggia
        • Contact:
          • Principal Investigator
      • Formia, Italy, 04023
        • Not yet recruiting
        • Ospedale Dono Svizzero
        • Contact:
          • Principal Investigator
      • Frosinone, Italy, 03100
        • Not yet recruiting
        • Ospedale Fabrizio Spaziani
        • Contact:
          • Principal Investigator
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino
        • Contact:
          • Principal Investigator
      • Genova, Italy, 16153
        • Recruiting
        • Presidio Ospedaliero S.O. Padre Antero Micone
        • Contact:
          • Principal Investigator
      • Grosseto, Italy, 58100
        • Not yet recruiting
        • Ospedale Della Misericordia
        • Contact:
          • Principal Investigator
      • La Spezia, Italy, 19121
        • Not yet recruiting
        • Ospedale Sant'Andrea
        • Contact:
          • Principal Investigator
      • Lamezia Terme, Italy, 88046
        • Not yet recruiting
        • ASP Catanzaro Presidio Ospedaliero "Giovanni Paolo II"
        • Contact:
          • Principal Investigator
      • Lecce, Italy, 73100
        • Active, not recruiting
        • Ospedale Vito Fazzi
      • Legnago, Italy, 37045
        • Not yet recruiting
        • Ospedale Mater Salutis
        • Contact:
          • Principal Investigator
      • Matera, Italy, 75100
        • Not yet recruiting
        • Presidio Ospedaliero "Madonna delle Grazie"
        • Contact:
          • Principal Investigator
      • Melfi, Italy, 85025
        • Not yet recruiting
        • Presidio ospedaliero San Giovanni di Dio
        • Contact:
          • Principal Investigator
      • Messina, Italy, 98124
        • Not yet recruiting
        • A.O.U. Policlinico "G. Martino"
        • Contact:
          • Principal Investigator
      • Mestre, Italy, 30174
        • Active, not recruiting
        • ULSS 3 SERENISSIMA Ospedale dell'Angelo
      • Milano, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20138
        • Recruiting
        • Centro Cardiologico Monzino
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20122
        • Not yet recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08039
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20122
        • Not yet recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08097
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20149
        • Not yet recruiting
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio -area MIND (ex area EXPO)
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20149
        • Not yet recruiting
        • Ospedale San Luca - Gruppo Istituto Auxologico Italiano
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20161
        • Not yet recruiting
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio -area MIND (ex area EXPO)
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20161
        • Not yet recruiting
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio
        • Contact:
          • Principal Investigator
      • Milano, Italy, 20162
        • Recruiting
        • Ospedale Niguarda
        • Contact:
          • Principal Investigator
      • Mirano, Italy, 30035
        • Active, not recruiting
        • ULSS 3 Serenissima Presidio Ospedaliero di Mirano
      • Modena, Italy, 41125
        • Not yet recruiting
        • AOU Modena Policlinico Modena
        • Contact:
          • Principal Investigator
      • Modena, Italy, 41126
        • Not yet recruiting
        • Ospedale Civile di Baggiovara
        • Contact:
          • Principal Investigator
      • Napoli, Italy, 80131
        • Not yet recruiting
        • A.O.U. Federico II
        • Contact:
          • Principal Investigator
      • Napoli, Italy, 80131
        • Not yet recruiting
        • A.O.R.N. Antonio Cardarelli
        • Contact:
          • Principal Investigator
      • Napoli, Italy, 80131
        • Active, not recruiting
        • A.O.R.N. MONALDI OSPEDALE DEI COLLI Ospedale Monaldi
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Specialistica dei Colli Ospedale Monaldi
        • Contact:
          • Principal Investigator
      • Napoli, Italy, 80131
        • Recruiting
        • Policlinico Università Federico II - Napoli
        • Contact:
          • Principal Investigator
      • Nocera Inferiore, Italy, 84014
        • Active, not recruiting
        • Ospedale Umberto I
      • Novara, Italy, 28100
        • Not yet recruiting
        • AOU Maggiore della Carità di Novara
        • Contact:
          • Principal Investigator
      • Novi Ligure, Italy, 15067
        • Not yet recruiting
        • Ospedale San Giacomo
        • Contact:
          • Principal Investigator
      • Padova, Italy, 35128
        • Not yet recruiting
        • Azienda ospedaliera-Università di Padova
        • Contact:
          • Principal Investigator
      • Palermo, Italy, 90127
        • Recruiting
        • A.O.U. Policlinico "P. Giaccone"
        • Contact:
          • Principal Investigator
      • Palermo, Italy, 90133
        • Recruiting
        • Casa di Cura Triolo Zancla Hospital
        • Contact:
          • Principal Investigator
      • Pavia, Italy, 27100
        • Recruiting
        • ICS Maugeri
        • Contact:
          • Principal Investigator
      • Perugia, Italy, 06126
        • Not yet recruiting
        • USL Umbria I
        • Contact:
          • Principal Investigator
      • Perugia, Italy, 06129
        • Not yet recruiting
        • Azienda Ospedaliera S. Maria della Misericordia di Perugia
        • Contact:
          • Principal Investigator
      • Piacenza, Italy, 29121
        • Not yet recruiting
        • Ospedale Guglielmo da Saliceto
        • Contact:
          • Principal Investigator
      • Pisa, Italy, 56124
        • Not yet recruiting
        • Fondazione Monasterio
        • Contact:
          • Principal Investigator
      • Portogruaro, Italy, 30026
        • Not yet recruiting
        • P. O. Portogruaro
        • Contact:
          • Principal Investigator
      • Potenza, Italy, 85100
        • Not yet recruiting
        • Azienda Ospedaliera Regionale San Carlo di Potenza
        • Contact:
          • Principal Investigator
      • Prato, Italy, 59100
        • Not yet recruiting
        • Nuovo Ospedale Santo Stefano
        • Contact:
          • Principal Investigator
      • Ragusa, Italy, 97100
        • Active, not recruiting
        • Azienda Sanitaria Provinciale di Ragusa Ospedale Giovanni Paolo II
      • Ravenna, Italy, 48121
        • Not yet recruiting
        • Ospedale Santa Maria delle Croci
        • Contact:
          • Principal Investigator
      • Rho, Italy, 20017
        • Not yet recruiting
        • ASST Rhodense - Ospedale di Circolo di Rho
        • Contact:
          • Principal Investigator
      • Rieti, Italy, 02100
        • Active, not recruiting
        • Ospedale San Camillo De Lellis
      • Rimini, Italy, 47923
        • Not yet recruiting
        • Ospedale Infermi AUSL Romagna
        • Contact:
          • Principal Investigator
      • Rivoli, Italy, 10098
        • Recruiting
        • Ospedale degli Infermi di Rivoli
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00161
        • Not yet recruiting
        • Policlinico Umberto I
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00133
        • Not yet recruiting
        • Policlinico Tor Vergata
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00157
        • Not yet recruiting
        • Ospedale Sandro Pertini
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08046
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08121
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00169
        • Not yet recruiting
        • Policlinico Casilino
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00184
        • Not yet recruiting
        • Azienda Ospedaliera San Giovanni Addolorata
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00189
        • Not yet recruiting
        • AOU S. Andrea
        • Contact:
          • Principal Investigator
      • Salerno, Italy, 84131
        • Not yet recruiting
        • A.O. San Giovanni di Dio e Ruggi D'Aragona
        • Contact:
          • Principal Investigator
      • Saronno, Italy, 21047
        • Not yet recruiting
        • ASST Valle Olona P.O. Saronno
        • Contact:
          • Principal Investigator
      • Sarzana, Italy, 19038
        • Not yet recruiting
        • Ospedale S. Bartolomeo
        • Contact:
          • Principal Investigator
      • Sassari, Italy, 07100
        • Not yet recruiting
        • AOU Sassari Ospedale SS. Annunziata
        • Contact:
          • Principal Investigator
      • Sesto San Giovanni, Italy, 20099
        • Not yet recruiting
        • IRCCS Multimedica
        • Contact:
          • Principal Investigator
      • Siena, Italy, 53100
        • Not yet recruiting
        • A.O.U. Senese Ospedale Santa Maria alle Scotte
        • Contact:
          • Principal Investigator
      • Siena, Italy, 53100
        • Not yet recruiting
        • AOU Senese- Policlinico Le Scotte
        • Contact:
          • Principal Investigator
      • Taranto, Italy, 74121
        • Not yet recruiting
        • Casa di cura Villa Verde
        • Contact:
          • Principal Investigator
      • Terni, Italy, 05100
        • Not yet recruiting
        • Azienda Ospedaliera Santa Maria
        • Contact:
          • Principal Investigator
      • Torino, Italy, 10128
        • Active, not recruiting
        • Ospedale Mauriziano Presidio Umberto I
      • Torrette, Italy, 60126
        • Recruiting
        • AOU Ospedali Riuniti di Ancona
        • Contact:
          • Principal Investigator
      • Trento, Italy, 38122
        • Not yet recruiting
        • Ospedale Santa Chiara
        • Contact:
          • Principal Investigator
      • Treviso, Italy, 31100
        • Not yet recruiting
        • ULLS 2 MARCA TREVIGIANA Ospedale Ca' Foncello
        • Contact:
          • Principal Investigator
      • Trieste, Italy, 34149
        • Not yet recruiting
        • Ospedale di Cattinara
        • Contact:
          • Principal Investigator
      • Udine, Italy, 33100
        • Not yet recruiting
        • Ospedale Santa Maria della Misericordia
        • Contact:
          • Principal Investigator
      • Urbino, Italy, 61029
        • Not yet recruiting
        • Ospedale Santa Maria della Misericordia
        • Contact:
          • Principal Investigator
      • Varese, Italy, 21100
        • Not yet recruiting
        • ASST Settelaghi Ospedale di Circolo e Fondazione Macchi
        • Contact:
          • Principal Investigator
      • Verbania, Italy, 28922
        • Not yet recruiting
        • Ospedale Castelli Verbania
        • Contact:
          • Principal Investigator
      • Bath, United Kingdom, BA1 3NG
        • Recruiting
        • Royal United Hospitals Bath NHS Foundation Trust
        • Contact:
          • Principal Investigator
      • Belfast, United Kingdom, BT16 1RH
        • Recruiting
        • South Eastern Ulster Hospital
        • Contact:
          • Principal Investigator
      • Cardiff, United Kingdom, CF64 2XX
        • Recruiting
        • University Hospital of Wales
        • Contact:
          • Principal Investigator
      • Chippenham, United Kingdom, SN15 2SB
        • Recruiting
        • Rowden Surgery
        • Contact:
          • Principal Investigator
      • Craigavon, United Kingdom, BT63 5QQ
        • Recruiting
        • Craigavon Area Hospital
        • Contact:
          • Principal Investigator
      • Darlington, United Kingdom, DL3 6HX
        • Recruiting
        • Darlington Memorial Hospital
        • Contact:
          • Principal Investigator
      • Darlington, United Kingdom, DL3 8SQ
        • Recruiting
        • Carmel Medical Practice
        • Contact:
          • Principal Investigator
      • Dartford, United Kingdom, DA2 8DA
        • Recruiting
        • Dartford and Gravesham NHS Trust Darent Valley Hospital
        • Contact:
          • Principal Investigator
      • Essex, United Kingdom, SS0 0RY
        • Recruiting
        • Southend University Hospital
        • Contact:
          • Principal Investigator
      • Hampshire, United Kingdom, PO8 8DL
        • Recruiting
        • Oaks Healthcare
        • Contact:
          • Principal Investigator
      • Leicester, United Kingdom, LE19 4LY
        • Recruiting
        • North Blaby PCN
        • Contact:
          • Principal Investigator
      • Lincoln, United Kingdom, LN2 5QY
        • Recruiting
        • Lincoln County Hospital
        • Contact:
          • Principal Investigator
      • London, United Kingdom, EC1M 6BQ
        • Recruiting
        • Barts Health NHS Trust/ QMUL
        • Contact:
          • Principal Investigator
      • London, United Kingdom, NW10 4ST
        • Recruiting
        • Freuchen Medical Centre
        • Contact:
          • Principal Investigator
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital Lipid Clinic
        • Contact:
          • Principal Investigator
      • London, United Kingdom, W6 8RP
        • Recruiting
        • Imperial College London
        • Contact:
          • Principal Investigator
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Wythenshawe Hospital
        • Contact:
          • Principal Investigator
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Royal Infirmary
        • Contact:
          • Principal Investigator
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • STRIVE, The James Cook University Hospital
        • Contact:
          • Principal Investigator
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • City Hospital
        • Contact:
          • Principal Investigator
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital Lipid Clinic
        • Contact:
          • Principal Investigator
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • North Manchester General Hospital
        • Contact:
          • Principal Investigator
      • Southampton, United Kingdom, SO30 3JB
        • Recruiting
        • Moorgreen Hospital
        • Contact:
          • Principal Investigator
      • Staffordshire, United Kingdom, DE13 0RB
        • Recruiting
        • Queen's Hospital Lipid Clinic
        • Contact:
          • Principal Investigator
      • Telford, United Kingdom, TF1 6TF
        • Recruiting
        • Princess Royal Hospital
        • Contact:
          • Principal Investigator
      • Torquay, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay and South Devon NHS Foundation Trust
        • Contact:
          • Principal Investigator
      • Trowbridge, United Kingdom, BA14 8LW
        • Recruiting
        • Trowbridge Health Centre
        • Contact:
          • Principal Investigator
      • Truro, United Kingdom, TR1 3LJ
        • Recruiting
        • Royal Cornwall Hospital
        • Contact:
          • Principal Investigator
      • Wales, United Kingdom, LL57 2PW
        • Recruiting
        • North Wales Cardiac Centre
        • Contact:
          • Principal Investigator
      • Wansford, United Kingdom, PE8 6PL
        • Recruiting
        • Wansford and Kings Cliffe Practice
        • Contact:
          • Principal Investigator
      • Watford, United Kingdom, WD18 7QR
        • Recruiting
        • Bridgewater Surgeries
        • Contact:
          • Principal Investigator
      • Watford, United Kingdom, WD25 7NL
        • Recruiting
        • Sheepcot Medical Centre
        • Contact:
          • Principal Investigator

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include participants with primary hypercholesterolemia or mixed dyslipidemia who are being treated with bempedoic acid and/or its fixed dose combination with ezetimibe.

Description

Inclusion Criteria:

  • Written informed consent to participate
  • At least 18 years of age
  • Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia treated or intended to be treated with bempedoic acid and/or its fixed dose combination with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
  • No contraindications exist according to the SmPC of bempedoic acid and/or its fixed-dose combination with ezetimibe
  • No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
  • Life expectancy > 1 year

Exclusion Criteria:

  • As this is a non-interventional study, no explicit exclusion criteria are defined. The prescribing behavior will not be influenced. Only patients will be included where the decision has been made by the treating physician to treat the patients either with bempedoic acid and/or its fixed-dose combination with ezetimibe.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bempedoic acid and/or fixed-dose combination with ezetimibe
Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.
This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Summary of patient characteristics in patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe
Time Frame: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overview of the cardiovascular risk of patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid/ and/or its fixed-dose combination with ezetimibe
Time Frame: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Cardiovascular risk scores will be assessed using the Systematic Coronary Risk Estimation (SCORE) system, Second manifestations of arterial disease (SMART) and Framingham risk scores. The SMART risk score will estimate 10-year risk for very high-risk participants based on clinical patient characteristics. The gender-specific Framingham risk score will be used to estimate 10-year cardiovascular risk for high-risk participants.
Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Summary of changes in plasma low-density lipoprotein cholesterol levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia
Time Frame: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Summary in changes in plasma levels of atherosclerotic cardiovascular disease-modifying cholesterol fragments following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe
Time Frame: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Plasma levels of total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs) and lipoprotein a (Lp[a]) will be assessed.
Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Summary of changes in plasma inflammatory marker hsCRP levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia
Time Frame: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)
Inflammatory status was assessed using high-sensitive C-reactive protein.
Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

Collaborators and Investigators

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

Investigators

  • Study Director: Global Clinical Leader, 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)

January 15, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Bempedoic acid and/or its fixed-dose combination with ezetimibe

3
Subscribe