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)
1 other identifier
observational
5,000
8 countries
443
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
443 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
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
March 20, 2026
March 1, 2026
5.8 years
October 1, 2020
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (4)
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
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
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
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
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)
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (443)
Dr. Armin Öhlinger Kardiologe & innere Medizin
Dornbirn, 6850, Austria
Landeskrankenhaus Feldkirch
Feldkirch, 6807, Austria
LKH-Univ. Klinikum Graz
Graz, 8036, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Internist Dr. med. univ. Stefan Moser
Hörsching, 4063, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
KABEG Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
Konventhospital der Barmherzigen Brüder Linz
Linz, 4020, Austria
Ordination Dr. Johannes Föchterle
Linz, 4040, Austria
Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl
Mattersburg, 7210, Austria
Kompetenz-Zentrum Diabetes
Salzburg, 5026, Austria
Ordination Universitätsdozent Dr. Alexander Kober
Sankt Aegyd am Neuwalde, 3193, Austria
Ordination Dr. med. univ. Evelyn Fließer-Görzer
Sankt Stefan ob Stainz, 8511, Austria
Ordination Dr. Thomas Maca
Vienna, 1010, Austria
Klinik Hietzing, Wiener Gesundheitsverbund
Vienna, 1030, Austria
Zentrum für Klinische Studien Dr. Hanusch GmbH
Vienna, 1060, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090, Austria
Univ.-Prof. Dr. Thomas Stulnig
Vienna, 1130, Austria
Herz Zentrum Währing
Vienna, 1180, Austria
Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung
Vienna, 1210, Austria
ASZ
Aalst, 9300, Belgium
Clinique Saint-Luc Bouge Namur
Bouge, B-5005, Belgium
Epicura Hornu
Boussu, B-7301, Belgium
A.Z. KLINA Brasschaat
Brasschaat, B-2930, Belgium
Clinique Saint-Jean Bruxelles
Brussels, B-1000, Belgium
CHU Brugman
Brussels, B-1020, Belgium
CUB-Hôpital Erasme
Brussels, B-1070, Belgium
UZ Brussel
Brussels, B-1090, Belgium
Clinique de l'Europe Saint Elisabeth
Brussels, B-1180, Belgium
UCL Saint-Luc Woluwé Bruxelles
Brussels, B-1200, Belgium
Private Practice
Ciney, B-5590, Belgium
Az Sint Blazius
Dendermonde, 9200, Belgium
UZ Antwerpen
Edegem, B-2650, Belgium
Z.O.L - Campus St. Jan
Genk, B-3600, Belgium
AZ St-Lucas & Volkskliniek
Ghent, B-9000, Belgium
UZ Gent
Ghent, B-9000, Belgium
GHDC Charleroi - Site Hôpital Saint-Joseph
Gilly, B-6060, Belgium
Private Practice
Gribomont, B-6887, Belgium
Pôle hospitalier Jolimont
Haine-Saint-Paul, B-7100, Belgium
BVBA Med Kab
Halen, B-3545, Belgium
Jessa Ziekenhuis
Hasselt, B-3500, Belgium
CHR Huy
Huy, B-4500, Belgium
JAN YPERMAN Ziekenhuis
Ieper, B-9800, Belgium
AZ Groeninge Kortrijk
Kortrijk, B-8500, Belgium
CHU Tivoli
La Louvière, B-7100, Belgium
UZ Leuven
Leuven, B-3000, Belgium
CHR Citadelle de Liège
Liège, B-4000, Belgium
CHU Liège
Liège, B-4000, Belgium
CHU Charleroi Hopital civil Marie-Curie
Lodelinsart, B-6042, Belgium
CHU Mons Ambroise Paré
Mons, B-7000, Belgium
AZ Sint Jan
Ostend, B-8400, Belgium
AZ Delta
Roeselare, B-8800, Belgium
AZ Glorieux
Ronse, B-9600, Belgium
Sint Trudo
Sint-Truiden, B-3800, Belgium
Sint-Andriesziekenhuis Tielt
Tielt, B-8700, Belgium
CHU UCL Mont-Godinne
Yvoir, B-5530, Belgium
Downtown Clinic Aachen
Aachen, 52062, Germany
Praxis Delonge
Aachen, 52078, Germany
Praxis Osterziel
Amberg, 92224, Germany
MVZ Helios Aue
Aue, 08280, Germany
Kardiologische Praxis Enders
Bad Elster, 08645, Germany
SLK-Klinikum am Plattenwald
Bad Friedrichshall, 74177, Germany
Herzcarre Praxis
Bad Homburg, 61348, Germany
Kardiologische Praxis
Bad Homburg, 61348, Germany
Zentrum für klinische Forschung
Bad Homburg, 61348, Germany
Universitätsklinikum Freiburg - Universitäts-Herzzentrum
Bad Krozingen, 79189, Germany
Praxis am Landratspark
Bad Segeberg, 23795, Germany
Hausärzte am Spritzenhaus
Baiersbronn, 72270, Germany
CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel
Bamberg, 96049, Germany
Kardiologische Praxis
Bechhofen, 66894, Germany
Praxis Rankestraße
Berlin, 10789, Germany
SKP Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbH
Berlin, 10789, Germany
Herzpraxis Berlin MVZ
Berlin, 12165, Germany
Charité - Universitätsmedizin Berlin
Berlin, 12203, Germany
Dres. Seeger & Partner
Berlin, 12627, Germany
Diabetespraxis Dr. Braun
Berlin, 13187, Germany
Lipidambulanz Charite
Berlin, 13353, Germany
Praxiszentrum Biedenkopf
Biedenkopf, 35216, Germany
Praxis Dr. A. Biedermann
Blankenhain, 99444, Germany
Kardiologische Gemeinschaftspraxis Bremerhaven
Bremerhaven, 27574, Germany
Kardiologie im Friedrichspalast Bruchsal
Bruchsal, 76646, Germany
MediClin Reha-Zentrum Spreewald
Burg, 03096, Germany
Studiengesellschaft Könemann und Steinmann GbR
Bünde, 32257, Germany
MVZ am Küchwald
Chemnitz, 09113, Germany
Kardiologische Praxis Stellmach
Chemnitz, 09126, Germany
MVZ Polymed
Chemnitz, 09130, Germany
Uniklinik Köln
Cologne, 50937, Germany
Zentrum für klinische Forschung
Cologne, 51069, Germany
IKAPP
Cologne, 51105, Germany
Praxis Dr. Menzel
Dessau, 06846, Germany
Klinikum Lippe GmbH
Detmold, 32756, Germany
Kardiologische Gemeinschaftspraxis
Dortmund, 44137, Germany
Cardiologicum Dresden/Pirna
Dresden, 01277, Germany
Hausärztliche Gemeinschaftspraxis mit diabetologischem Schwerpunkt
Dresden, 01279, Germany
Dres. Günther/Kolschmann
Dresden, 01307, Germany
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
DZDM Diabeteszentrum Duisburg Mitte
Duisburg, 47051, Germany
Nierenzentrum Düren
Düren, 52351, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Praxis Dilltal
Ehringshausen, 35630, Germany
Praxis Dipl. -Med. Petra Herrmann
Eisenach, 99817, Germany
Kardiologische Praxis
Elsterwerda, 04910, Germany
Gemeinschaftspraxis ISP Erlangen
Erlangen, 91052, Germany
Hausarztzentrum am Germaniaplatz
Essen, 45355, Germany
DIAKO Flensburg
Flensburg, 24939, Germany
Praxis für Nieren und Hochdruck-Krankheiten
Flensburg, 24941, Germany
MVZ Altstadt-Carree Fulda
Fulda, 36037, Germany
Klinikum Fulda
Fulda, 63043, Germany
Praxis Dr. Langel
Gera, 07551, Germany
Cardiocampus Gemeinschaftspraxis für Herz- und Kreislauferkrankungen
Gifhorn, 38518, Germany
Praxis für Gefäßmedizin
Görlitz, 02827, Germany
Universitätsmedizin Göttingen
Göttingen, 37075, Germany
Praxis Dr. Müller
Gräfenhainichen, 06773, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Evangelisches Krankenhaus Hagen-Haspe
Hagen, 58135, Germany
Praxis
Hainburg, 63512, Germany
Cardiologicum Hamburg - Praxis Wandsbek
Hamburg, 22041, Germany
Diabetes Zentrum Wandsbeck
Hamburg, 22041, Germany
MVZ Prof. Mathey, Prof. Schofer
Hamburg, 22527, Germany
Kardiologie am Tibarg
Hamburg, 22549, Germany
Kardiologie List
Hanover, 30177, Germany
Kardiologische Praxis
Hanover, 30559, Germany
Kardiologische Praxis
Haßloch, 67454, Germany
Kardiologische Schwerpunktpraxis
Heidelberg, 69115, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Praxis Heik/Wedig
Heiligenstadt, 37308, Germany
KARDIO-IN Kardiologische Gemeinschaftspraxis
Ingolstadt, 85049, Germany
Kardiologische Praxis
Kaiserslautern, 67655, Germany
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, 76307, Germany
B. Braun Ambulantes Herzzentrum Kassel
Kassel, 34121, Germany
Praxis Dr. Heiner Müller
Katzhütte, 98746, Germany
Nephrologie Kiel
Kiel, 24106, Germany
Gemeinschaftsklinikum Mittelrhein
Koblenz, 56068, Germany
Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz
Konstanz, 78464, Germany
Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann
Kornwestheim, 70806, Germany
Kardiologische Praxis Kyritz
Kyritz, 16866, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Kardiologische Praxis Boudriot
Leipzig, 04129, Germany
MVZ Stoffwechselmedizin Leipzig
Leipzig, 04317, Germany
Praxis Dr. I.Simon-Wagner
Lichtenfels, 96215, Germany
St. Vincenz Krankenhaus
Limburg, 65549, Germany
Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet
Löhne, 32584, Germany
Cardio Centrum Ludwigsburg-Bietigheim
Ludwigsburg, 71634, Germany
Kardiologische Praxisklinik Ludwigshafen
Ludwigshafen, 67071, Germany
Universität zu Lübeck
Lübeck, 23538, Germany
Institut für Präventive Medizin & Klinische Forschung GbR
Magdeburg, 39110, Germany
Cardiopraxis Mainz
Mainz, 55122, Germany
Katholisches Klinikum Mainz
Mainz, 55131, Germany
Universitätsklinikum Mainz
Mainz, 55131, Germany
ZE:RO Praxen
Mannheim, 68165, Germany
UMM Mannheim
Mannheim, 68167, Germany
Kardiologische Praxis
Markkleeberg, 04416, Germany
Praxis Ben-Chur
Meiningen, 98617, Germany
Praxis Haj-Yehia
Moers, 47441, Germany
Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte
Mühldorf, 84453, Germany
Kardiologie Mühldorf am Inn
Mühldorf, 84453, Germany
Herzquartier Mülheim
Mülheim, 45468, Germany
Kardiologie Neuhausen-Nymphenburg
München, 80634, Germany
Dres. Wauer/Windstetter
München, 80799, Germany
Praxis Kiepenkerl
Münster, 48143, Germany
Zentrum für Kardiologie an der Raphaelsklinik Münster
Münster, 48143, Germany
Praxis für Innere Medizin Münster
Münster, 48149, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Internistische Praxisgemeinschaft
Neu-Isenburg, 63263, Germany
Kardiologische Praxis Northeim
Northeim, 37154, Germany
Hausarztpraxis
Oer-Erkenschwick, 45739, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098, Germany
Kardiologische Praxis Papenburg - Site 6071
Papenburg, 26871, Germany
Kardiologische Praxis Papenburg - Site 6072
Papenburg, 26871, Germany
Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan
Passau, 94032, Germany
Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH
Pirna, 01796, Germany
Kinikum Ernst von Bergmann
Potsdam, 14467, Germany
VieSante Herzmedizin Potsdam
Potsdam, 14469, Germany
Kardiologische Gemeinschaftspraxis
Potsdam, 14471, Germany
Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann
Radebeul, 01445, Germany
Internistisch hausärtzliche Gemeinschaftspraxis Dr. Hildebrandt & Dr. Mutscher
Radebeul, 01445, Germany
Gemeinschaftspraxis Herz Riesa
Riesa, 01587, Germany
Universitätsmedizin Rostock
Rostock, 18057, Germany
Facharztpraxis für Kardiologie und Innere Medizin
Schwäbisch Hall, 74523, Germany
MVZ Schwerin West GmbH
Schwerin, 19057, Germany
Nierenzentrum Altmark
Seehausen, 39615, Germany
Zentrum für Prävention und Rehabilitation
Siegen, 57072, Germany
Klinik Singen
Singen, 78224, Germany
MEDINOS Klinik Sonneberg
Sonneberg, 96515, Germany
Kardiologische Praxis im Steiner Thor
Straubing, 94315, Germany
Praxis Dr Knöbel u. Partner
Straubing, 94315, Germany
Praxis Dr. Michael Rother
Strausberg, 15344, Germany
Diabetologische Schwerpunktpraxis
Trier, 54292, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292, Germany
Studienzentrum der Herzklinik Ulm GbR
Ulm, 89077, Germany
Praxis Dr. Hansen
Unterwellenborn, 07333, Germany
Praxis Dr. Dengler/Hohenstatt
Ursensollen, 92289, Germany
Herzzentrum Saar
Völklingen, 66333, Germany
GRN Weinheim
Weinheim, 69469, Germany
Kardiologische Praxis Al-Zoebi
Wermsdorf, 04779, Germany
Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße
Weyhe, 28844, Germany
Forschungszentrum-Ruhr / KliFoCenter GmbH
Witten, 58455, Germany
Kardiologische Praxis Tamm/Hoh
Wittenberg, 06886, Germany
Kardiologische Fachpraxis
Wolmirstedt, 39326, Germany
Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue
Wuppertal, 42103, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Gemeinschaftspraxis am Angerbrunnen
Zwiesel, 94227, Germany
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, 70021, Italy
P.O. Agrigento Ospedale San Giovanni di Dio
Agrigento, 92100, Italy
IRCCS-INRCA Ancona
Ancona, 60127, Italy
Ospedale di Anzio
Anzio, 00042, Italy
Ospedale dei Castelli
Ariccia, 00072, Italy
Ospedale "C. e G. Mazzoni"
Ascoli Piceno, 63100, Italy
A.O. San Giuseppe Moscati
Avellino, 83100, Italy
Ospedale SS Nicola e Filippo
Avezzano, 67051, Italy
Ospedale S. Paolo
Bari, 70123, Italy
A.O.U. Consorziale - Policlinico Bari
Bari, 70124, Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08016
Bari, 70124, Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08017
Bari, 70124, Italy
AUSL Bologna Ospedale di Bentivoglio
Bentivoglio, 40010, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale Maggiore Carlo Alberto Pizzardi
Bologna, 40133, Italy
Policlinico Sant'Orsola Bologna-Malpighi
Bologna, 40138, Italy
Ospedale di Bolzano - Site 08070
Bolzano, 39100, Italy
Ospedale di Bolzano - Site 08112
Bolzano, 39100, Italy
Spedali Civili di Brescia
Brescia, 25123, Italy
Ospedale Santo Spirito Casale Monferrato
Casale Monferrato, 15033, Italy
A.O. S. Anna e S. Sebastiano
Caserta, 81100, Italy
ULLS 2 MARCA TREVIGIANA Ospedale di Castelfranco Veneto
Castelfranco Veneto, 31033, Italy
AOU Policlinico Vittorio Emanuele Presidio Ospedaliero Gaspare Rodolico
Catania, 95124, Italy
Azienda Ospedaliera Cannizzaro
Catania, 95126, Italy
L'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
Catanzaro, 88100, Italy
Ospedale Civile Santa Maria Incoronata dell'Olmo
Cava de' Tirreni, 84013, Italy
Policlinico SS. Annunziata
Chieti, 66100, Italy
ASL TO4 Presidio Riunito di Ciriè-Lanzo
Cirié, 10073, Italy
Azienda Ospedaliero-Universitaria di Ferrara "Arcispedale Sant'Anna"
Cona, 44124, Italy
Ospedale San Salvatore
Coppito, 67100, Italy
Ospedale Santa Maria Nuova
Florence, 50122, Italy
AOU Careggi - Site 08067
Florence, 50134, Italy
AOU Careggi - Site 08081
Florence, 50134, Italy
AOU Careggi - Site 08090
Florence, 50134, Italy
Azienda Ospedaliera Universitaria "Ospedali Riuniti" di Foggia
Foggia, 71122, Italy
Ospedale Policlinico San Martino
Genova, 16132, Italy
Presidio Ospedaliero S.O. Padre Antero Micone
Genova, 16153, Italy
Ospedale della Misericordia
Grosseto, 58100, Italy
Ospedale Sant'Andrea
La Spezia, 19121, Italy
ASP Catanzaro Presidio Ospedaliero "Giovanni Paolo II"
Lamezia Terme, 88046, Italy
Ospedale Vito Fazzi
Lecce, 73100, Italy
Ospedale Mater Salutis
Legnago, 37045, Italy
Presidio Ospedaliero "Madonna delle Grazie"
Matera, 75100, Italy
Presidio ospedaliero San Giovanni di Dio
Melfi, 85025, Italy
A.O.U. Policlinico "G. Martino"
Messina, 98124, Italy
ULSS 3 SERENISSIMA Ospedale dell'Angelo
Mestre, 30174, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08039
Milan, 20122, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08097
Milan, 20122, Italy
Centro Cardiologico Monzino
Milan, 20138, Italy
Ospedale San Luca - Gruppo Istituto Auxologico Italiano
Milan, 20149, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Ospedale Niguarda
Milan, 20162, Italy
ULSS 3 Serenissima Presidio Ospedaliero di Mirano
Mirano, 30035, Italy
AOU Modena Policlinico Modena
Modena, 41125, Italy
A.O.R.N. Antonio Cardarelli
Naples, 80131, Italy
A.O.R.N. MONALDI OSPEDALE DEI COLLI Ospedale Monaldi
Naples, 80131, Italy
A.O.U. Federico Ii
Naples, 80131, Italy
Azienda Ospedaliera Specialistica dei Colli Ospedale Monaldi
Naples, 80131, Italy
Policlinico Università Federico II - Napoli
Naples, 80131, Italy
Ospedale Umberto I
Nocera Inferiore, 84014, Italy
AOU Maggiore della Carità di Novara
Novara, 28100, Italy
Ospedale San Giacomo
Novi Ligure, 15067, Italy
Azienda ospedaliera-Università di Padova
Padua, 35128, Italy
A.O.U. Policlinico "P. Giaccone"
Palermo, 90127, Italy
Casa di Cura Triolo Zancla Hospital
Palermo, 90133, Italy
ICS Maugeri
Pavia, 27100, Italy
USL Umbria I
Perugia, 06126, Italy
Azienda Ospedaliera S. Maria della Misericordia di Perugia
Perugia, 06129, Italy
Ospedale Guglielmo da Saliceto
Piacenza, 29121, Italy
Fondazione Monasterio
Pisa, 56124, Italy
P. O. Portogruaro
Portogruaro, 30026, Italy
Azienda Ospedaliera Regionale San Carlo di Potenza
Potenza, 85100, Italy
Nuovo Ospedale Santo Stefano
Prato, 59100, Italy
Azienda Sanitaria Provinciale di Ragusa Ospedale Giovanni Paolo II
Ragusa, 97100, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
ASST Rhodense - Ospedale di Circolo di Rho
Rho, 20017, Italy
Ospedale San Camillo De Lellis
Rieti, 02100, Italy
Ospedale Infermi AUSL Romagna
Rimini, 47923, Italy
Ospedale degli Infermi di Rivoli
Rivoli, 10098, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Ospedale Sandro Pertini
Roma, 00157, Italy
Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08046
Roma, 00168, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08121
Roma, 00168, Italy
Policlinico Casilino
Roma, 00169, Italy
AOU S. Andrea
Roma, 00189, Italy
A.O. San Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131, Italy
ASST Valle Olona P.O. Saronno
Saronno, 21047, Italy
Ospedale S. Bartolomeo
Sarzana, 19038, Italy
AOU Sassari Ospedale SS. Annunziata
Sassari, 07100, Italy
IRCCS Multimedica
Sesto San Giovanni, 20099, Italy
A.O.U. Senese Ospedale Santa Maria alle Scotte
Siena, 53100, Italy
AOU Senese- Policlinico Le Scotte
Siena, 53100, Italy
Casa di cura Villa Verde
Taranto, 74121, Italy
Azienda Ospedaliera Santa Maria
Terni, 05100, Italy
Ospedale Mauriziano Presidio Umberto I
Torino, 10128, Italy
AOU Ospedali Riuniti di Ancona
Torrette, 60126, Italy
Ospedale Santa Chiara
Trento, 38122, Italy
ULLS 2 MARCA TREVIGIANA Ospedale Ca' Foncello
Treviso, 31100, Italy
Ospedale di Cattinara
Trieste, 34149, Italy
Ospedale Santa Maria della Misericordia
Udine, 33100, Italy
Ospedale Santa Maria della Misericordia
Urbino, 61029, Italy
ASST Settelaghi Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
Ospedale Castelli Verbania
Verbania, 28922, Italy
ZGT
Almelo, 7609 PP, Netherlands
Meander Mc
Amersfoort, 3813 TZ, Netherlands
AUMC
Amsterdam, 1105 AZ, Netherlands
Mc Leeuwarden
Amsterdam, 8934 AD, Netherlands
Rijnstate
Arnhem, 6815 AD, Netherlands
AMPHIA
Breda, 4818 CK, Netherlands
Albert Schweitzer
Dordrecht, 3318 AT, Netherlands
ZGV
Ede, 6716 RP, Netherlands
Maxima Medisch Centrum
Eindhoven, 5631 BM, Netherlands
GHZ
Gouda, 2803 HH, Netherlands
Spaarne Gasthuis
Haarlem, 2035 RC, Netherlands
Saxenburgh Medisch Centrum
Hardenberg, 7772 SE, Netherlands
Tergooi Mc
Hilversum, 1212 VG, Netherlands
Treant Bethesda Hoogeveen
Hoogeveen, 7900 RA, Netherlands
Dijklander
Hoorn, 1624 NP, Netherlands
ALRIJNE
Leiderdorp, 2353 GA, Netherlands
MUMC+
Maastricht, 6229 HX, Netherlands
Erasmus Mc
Rotterdam, 3015 GD, Netherlands
Franciscus Gasthuis
Rotterdam, 3045 PM, Netherlands
MAASSTAD
Rotterdam, 3079 DZ, Netherlands
Isala Zwolle
Zwolle, 8025 AB, Netherlands
Hospital General de Albacete
Albacete, 02006, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, 28922, Spain
Hospital Virgen de los Lirios
Alcoy, 03804, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Universitario Torrecárdenas
Almería, 04009, Spain
Hospital Universitario Central de Asturias
Asturias, 33011, Spain
Clínica Mapfre Salud Gijón
Asturias, 33202, Spain
Hospital Universitario San Agustin
Asturias, 33410, Spain
Hospital Universitario Nuestra Señora del Perpetuo Socorro
Badajoz, 06010, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital de Bellvitge
Barcelona, 08902, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Hospital Universitario de Burgos
Burgos, 09003, Spain
Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
Hospital General Universitario de Castellón
Castellon, 12004, Spain
Hospital Universitario San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital del Henares
Coslada, Madrid, 28822, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital de Denia
Denia, 03700, Spain
Hospital UNiversitario de Donostia
Donostia / San Sebastian, 20014, Spain
Hospital de Fuenlabrada
Fuenlabrada Madrid, 28942, Spain
Hospital Universitario de Cabueñes
Gijón, 33394, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18013, Spain
Hospital Universitario San Cecilio
Granada, 18016, Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, 21110, Spain
Hospital Universitario Médico-Quirúrgico de Jaén
Jaén, 23007, Spain
Hospital Jerez de la Frontera
Jerez de La Frontera, Cádiz, 11407, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, 35010, Spain
Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario de León
León, 24008, Spain
Hospital San Pedro
Logroño, 26006, Spain
Hospital Universitario la Princesa
Madrid, 28006, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Ruber Internacional
Madrid, 28034, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Clínico Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital HM Montepríncipe
Madrid, 28660, Spain
Hospital Universitario de Torrejón
Madrid, 28850, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majdahonda Madrid, 28222, Spain
Hospital Costa del Sol
Marbella Málaga, 29603, Spain
Consulta de Cardiología Dr. Javier Mora Robles
Málaga, 29002, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital de Mendaro
Mendaro, 20850, Spain
Hospital General Universitario Reina Sofía
Murcia, 30003, Spain
Hospital Clínico Universitario Virgen Arrixaca
Murcia, 30120, Spain
Hospital Universitario Son LLatzer
Palma de Mallorca, 07193, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Hospital de Sagunto
Port de Sagunt, 46520, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital de Valme
Seville, 41014, Spain
Hospital Universitario Vírgen del Rocío
Seville, 411013, Spain
Hospital General Universitario de Toledo
Toledo, 45007, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Vithas Valencia 9 de Octubre
Valencia, 46015, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46016, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026, Spain
Hospital Universitario Rio Hortega
Valladolid, 47130, Spain
Hospital de La Plana
Villarreal, Castellón, 12540, Spain
Hospital Clinico Universitaro Lozano Blesa
Zaragoza, 50009, Spain
Diabetologie & Endokrinologie Baden
Baden, 5400, Switzerland
University Hospital Basel
Basel, 4031, Switzerland
Inselspital, Universitätsspital Bern
Bern, 3010, Switzerland
Praxis Dr. med Urs Beat Gröflin
Binningen, 4102, Switzerland
Hochgebirgsklinik Davos
Davos, 7265, Switzerland
Spital Lachen AG
Lachen, 8853, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011, Switzerland
University of Lausanne
Lausanne, 1011, Switzerland
Kantonsspital Baselland
Liestal, 4410, Switzerland
EOC Ente Ospedaliero Cantonale
Lugano, 6900, Switzerland
MIP Associazione Medico in Pratica c/o Studio Medico Cardiologico Acquistapace
Lugano, 6900, Switzerland
Praxis Prof. Dr. med. Gottfried Rudofsky
Olten, 4600, Switzerland
HÔPITAL RIVIERA-CHABLAIS, VAUD-VALAIS, Centre hospitalier de Rennaz
Rennaz, 1847, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, CH-9007, Switzerland
Spital Thun
Thun, 3600, Switzerland
Prof. Dr. med. Stephane Bosquet
Yverdon-les-Bains, 1400, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
South Eastern Ulster Hospital
Belfast, BT16 1RH, United Kingdom
University Hospital of Wales
Cardiff, CF64 2XX, United Kingdom
Rowden Surgery
Chippenham, SN15 2SB, United Kingdom
Craigavon Area Hospital
Craigavon, BT63 5QQ, United Kingdom
Darlington Memorial Hospital
Darlington, DL3 6HX, United Kingdom
University Hospital North Durham
Durham, DH1 5TW, United Kingdom
Oaks Healthcare
Hampshire, PO8 8DL, United Kingdom
West Morland General Hospital
Kendal, LA9 7RG, United Kingdom
North Blaby PCN
Leicester, LE19 4LY, United Kingdom
Barts Health NHS Trust/ QMUL
London, EC1M 6BQ, United Kingdom
Freuchen Medical Centre
London, NW10 4ST, United Kingdom
Royal Free Hospital Lipid Clinic
London, NW3 2QG, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Imperial College London
London, W6 8RP, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M23 9LT, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
STRIVE, The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
North Tees Hospital
Northumbria, TS19 8PE, United Kingdom
City Hospital
Nottingham, NG5 1PB, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Whiston Hospital
Prescot, L35 5DR, United Kingdom
North Manchester General Hospital
Salford, M6 8HD, United Kingdom
Queen's Hospital Lipid Clinic
Staffordshire, DE13 0RB, United Kingdom
Princess Royal Hospital
Telford, TF1 6TF, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, TQ2 7AA, United Kingdom
Trowbridge Health Centre
Trowbridge, BA14 8LW, United Kingdom
North Wales Cardiac Centre
Wales, LL57 2PW, United Kingdom
Wansford and Kings Cliffe Practice
Wansford, PE8 6PL, United Kingdom
Bridgewater Surgeries
Watford, WD18 7QR, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 8, 2020
Study Start
January 15, 2021
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/