Clinical trial NCT04579367: Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Mixed Dyslipidemia
Keywords: Hypercholesterolemia
Mixed dyslipidemia
Bempedoic acid and/or its fixed-dose combination with ezetimibe
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
Other outcomes:
Locations:
city: Dornbirn
country: Austria
facility: Dr. Armin Öhlinger Kardiologe & innere Medizin
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Graz
country: Austria
facility: Institut für Herz- und Gefäßerkrankungen GmbH
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Horsching
country: Austria
facility: Internist Dr. med. univ. Stefan Moser
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Klagenfurt am Worthersee
country: Austria
facility: KABEG Klinikum Klagenfurt am Wörthersee
city: Linz
country: Austria
facility: Konventhospital der Barmherzigen Brüder Linz
city: Linz
country: Austria
facility: Ordination Dr. Johannes Föchterle
city: Mattersburg
country: Austria
facility: Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl
city: Melk
country: Austria
facility: Landesklinikum Melk
city: Salzburg
country: Austria
facility: Kompetenz-Zentrum Diabetes
city: Sankt Aegyd Am Neuwalde
country: Austria
facility: Ordination Universitätsdozent Dr. Alexander Kober
city: Sankt Stefan Ob Stainz
country: Austria
facility: Ordination Dr. med. univ. Evelyn Fließer-Görzer
city: Villach
country: Austria
facility: Landeskrankenhaus Villach
city: Wien
country: Austria
facility: Ordination Dr. Thomas Maca
city: Wien
country: Austria
facility: Klinik Hietzing, Wiener Gesundheitsverbund
city: Wien
country: Austria
facility: Zentrum für Klinische Studien Dr. Hanusch GmbH
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: Univ.-Prof. Dr. Thomas Stulnig
city: Wien
country: Austria
facility: Herz Zentrum Währing
city: Wien
country: Austria
facility: Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung
city: Wien
country: Austria
facility: Schnürer & Fritsch - Gruppenpraxis für Innere Medizin
city: Aalst
country: Belgium
facility: ASZ
city: Bouge
country: Belgium
facility: Clinique Saint-Luc Bouge Namur
city: Boussu
country: Belgium
facility: Epicura Hornu
city: Brasschaat
country: Belgium
facility: A.Z. KLINA Brasschaat
city: Bruxelles
country: Belgium
facility: Clinique Saint-Jean Bruxelles
city: Bruxelles
country: Belgium
facility: CHU Brugman
city: Bruxelles
country: Belgium
facility: CUB-Hôpital Erasme
city: Bruxelles
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Clinique de l'Europe Saint Elisabeth
city: Bruxelles
country: Belgium
facility: UCL Saint-Luc Woluwé Bruxelles
city: Ciney
country: Belgium
facility: Private Practice
city: Dendermonde
country: Belgium
facility: Az Sint Blazius
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: Z.O.L - Campus St. Jan
city: Ghent
country: Belgium
facility: AZ St-Lucas & Volkskliniek
city: Ghent
country: Belgium
facility: UZ Gent
city: Gilly
country: Belgium
facility: GHDC Charleroi - Site Hôpital Saint-Joseph
city: Gribomont
country: Belgium
facility: Private Practice
city: Haine-Saint-Paul
country: Belgium
facility: Pôle hospitalier Jolimont
city: Halen
country: Belgium
facility: BVBA Med Kab
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Huy
country: Belgium
facility: CHR Huy
city: Ieper
country: Belgium
facility: JAN YPERMAN Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHR Citadelle de Liège
city: Liège
country: Belgium
facility: CHU Liège
city: Lodelinsart
country: Belgium
facility: CHU Charleroi Hopital civil Marie-Curie
city: Mons
country: Belgium
facility: CHU Mons Ambroise Paré
city: Oostende
country: Belgium
facility: AZ Sint Jan
city: Roeselare
country: Belgium
facility: AZ Delta
city: Ronse
country: Belgium
facility: AZ Glorieux
city: Sint Truiden
country: Belgium
facility: Sint Trudo
city: Tielt
country: Belgium
facility: Sint-Andriesziekenhuis Tielt
city: Tienen
country: Belgium
facility: Private Practice
city: Yvoir
country: Belgium
facility: CHU UCL Mont-Godinne
city: Aachen
country: Germany
facility: Downtown Clinic Aachen
city: Aachen
country: Germany
facility: Praxis Delonge
city: Amberg
country: Germany
facility: Praxis Osterziel
city: Aue
country: Germany
facility: MVZ Helios Aue
city: Bad Elster
country: Germany
facility: Kardiologische Praxis Enders
city: Bad Friedrichshall
country: Germany
facility: SLK-Klinikum am Plattenwald
city: Bad Homburg
country: Germany
facility: Herzcarre Praxis
city: Bad Homburg
country: Germany
facility: Kardiologische Praxis
city: Bad Homburg
country: Germany
facility: Zentrum für klinische Forschung
city: Bad Krozingen
country: Germany
facility: Universitätsklinikum Freiburg - Universitäts-Herzzentrum
city: Bad Segeberg
country: Germany
facility: Praxis am Landratspark
city: Baiersbronn
country: Germany
facility: Hausärzte am Spritzenhaus
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel
city: Bechhofen
country: Germany
facility: Kardiologische Praxis
city: Berlin
country: Germany
facility: Praxis Rankestraße
city: Berlin
country: Germany
facility: SKP Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbH
city: Berlin
country: Germany
facility: Herzpraxis Berlin MVZ
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Dres. Seeger & Partner
city: Berlin
country: Germany
facility: Diabetespraxis Dr. Braun
city: Berlin
country: Germany
facility: Lipidambulanz Charite
city: Biedenkopf
country: Germany
facility: Praxiszentrum Biedenkopf
city: Blankenhain
country: Germany
facility: Praxis Dr. A. Biedermann
city: Bonn
country: Germany
facility: MVZ für Innere Medizin
city: Bremerhaven
country: Germany
facility: Kardiologische Gemeinschaftspraxis Bremerhaven
city: Bruchsal
country: Germany
facility: Kardiologie im Friedrichspalast Bruchsal
city: Bunde
country: Germany
facility: Studiengesellschaft Könemann und Steinmann GbR
city: Burg
country: Germany
facility: MediClin Reha-Zentrum Spreewald
city: Bünde
country: Germany
facility: Studiengesellschaft Könemann und Steinmann GbR
city: Chemnitz
country: Germany
facility: MVZ am Küchwald
city: Chemnitz
country: Germany
facility: Kardiologische Praxis Stellmach
city: Chemnitz
country: Germany
facility: MVZ Polymed
city: Dessau
country: Germany
facility: Praxis Dr. Menzel
city: Detmold
country: Germany
facility: Klinikum Lippe GmbH
city: Dortmund
country: Germany
facility: Kardiologische Gemeinschaftspraxis
city: Dresden
country: Germany
facility: Cardiologicum Dresden/Pirna
city: Dresden
country: Germany
facility: Hausärztliche Gemeinschaftspraxis mit diabetologischem Schwerpunkt
city: Dresden
country: Germany
facility: Dres. Günther/Kolschmann
city: Dresden
country: Germany
facility: Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Duisburg
country: Germany
facility: DZDM Diabeteszentrum Duisburg Mitte
city: Düren
country: Germany
facility: Nierenzentrum Düren
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Ehringshausen
country: Germany
facility: Praxis Dilltal
city: Eisenach
country: Germany
facility: Praxis Dipl. -Med. Petra Herrmann
city: Elsterwerda
country: Germany
facility: Kardiologische Praxis
city: Erlangen
country: Germany
facility: Gemeinschaftspraxis ISP Erlangen
city: Essen
country: Germany
facility: Hausarztzentrum am Germaniaplatz
city: Flensburg
country: Germany
facility: DIAKO Flensburg
city: Flensburg
country: Germany
facility: Praxis für Nieren und Hochdruck-Krankheiten
city: Fulda
country: Germany
facility: MVZ Altstadt-Carree Fulda
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Gera
country: Germany
facility: Praxis Dr. Langel
city: Gifhorn
country: Germany
facility: Cardiocampus Gemeinschaftspraxis für Herz- und Kreislauferkrankungen
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Gräfenhainichen
country: Germany
facility: Praxis Dr. Müller
city: Görlitz
country: Germany
facility: Praxis für Gefäßmedizin
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hagen
country: Germany
facility: Evangelisches Krankenhaus Hagen-Haspe
city: Hainburg
country: Germany
facility: Praxis
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg - Praxis Wandsbek
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wandsbeck
city: Hamburg
country: Germany
facility: MVZ Prof. Mathey, Prof. Schofer
city: Hamburg
country: Germany
facility: Kardiologie am Tibarg
city: Hannover
country: Germany
facility: Kardiologie List
city: Hannover
country: Germany
facility: Kardiologische Praxis
city: Haßloch
country: Germany
facility: Kardiologische Praxis
city: Heidelberg
country: Germany
facility: Kardiologische Schwerpunktpraxis
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Heiligenstadt
country: Germany
facility: Praxis Heik/Wedig
city: Ingolstadt
country: Germany
facility: KARDIO-IN Kardiologische Gemeinschaftspraxis
city: Kaiserslautern
country: Germany
facility: Kardiologische Praxis
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach
city: Kassel
country: Germany
facility: B. Braun Ambulantes Herzzentrum Kassel
city: Katzhütte
country: Germany
facility: Praxis Dr. Heiner Müller
city: Kiel
country: Germany
facility: Nephrologie Kiel
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein
city: Konstanz
country: Germany
facility: Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz
city: Kornwestheim
country: Germany
facility: Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann
city: Kyritz
country: Germany
facility: Kardiologische Praxis Kyritz
city: Köln
country: Germany
facility: Uniklinik Köln
city: Köln
country: Germany
facility: Zentrum für klinische Forschung
city: Köln
country: Germany
facility: IKAPP
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: Kardiologische Praxis Boudriot
city: Leipzig
country: Germany
facility: MVZ Stoffwechselmedizin Leipzig
city: Lichtenfels
country: Germany
facility: Praxis Dr. I.Simon-Wagner
city: Limburg
country: Germany
facility: St. Vincenz Krankenhaus
city: Lohne
country: Germany
facility: Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet
city: Ludwigsburg
country: Germany
facility: Cardio Centrum Ludwigsburg-Bietigheim
city: Ludwigshafen
country: Germany
facility: Kardiologische Praxisklinik Ludwigshafen
city: Luebeck
country: Germany
facility: Universität zu Lübeck
city: Lutherstadt Wittenberg
country: Germany
facility: Kardiologische Praxis Tamm/Hoh
city: Magdeburg
country: Germany
facility: Institut für Präventive Medizin & Klinische Forschung GbR
city: Mainz
country: Germany
facility: Cardiopraxis Mainz
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Mannheim
country: Germany
facility: ZE:RO Praxen
city: Mannheim
country: Germany
facility: UMM Mannheim
city: Markkleeberg
country: Germany
facility: Kardiologische Praxis
city: Meiningen
country: Germany
facility: Praxis Ben-Chur
city: Moers
country: Germany
facility: Praxis Haj-Yehia
city: Mühldorf
country: Germany
facility: Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte
city: Mühldorf
country: Germany
facility: Kardiologie Mühldorf am Inn
city: Mülheim an der Ruhr
country: Germany
facility: Herzquartier Mülheim
city: München
country: Germany
facility: Kardiologie Neuhausen-Nymphenburg
city: München
country: Germany
facility: Dres. Wauer/Windstetter
city: Münster
country: Germany
facility: Praxis Kiepenkerl
city: Münster
country: Germany
facility: Zentrum für Kardiologie an der Raphaelsklinik Münster
city: Münster
country: Germany
facility: Praxis für Innere Medizin Münster
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Neu Isenburg
country: Germany
facility: Internistische Praxisgemeinschaft
city: Northeim
country: Germany
facility: Kardiologische Praxis Northeim
city: Oer-Erkenschwick
country: Germany
facility: Hausarztpraxis
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH
city: Papenburg
country: Germany
facility: Kardiologische Praxis Papenburg - Site 6071
city: Papenburg
country: Germany
facility: Kardiologische Praxis Papenburg - Site 6072
city: Passau
country: Germany
facility: Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan
city: Pirna
country: Germany
facility: Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH
city: Potsdam
country: Germany
facility: Kinikum Ernst von Bergmann
city: Potsdam
country: Germany
facility: VieSante Herzmedizin Potsdam
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis
city: Radebeul
country: Germany
facility: Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann
city: Radebeul
country: Germany
facility: Internistisch hausärtzliche Gemeinschaftspraxis Dr. Hildebrandt & Dr. Mutscher
city: Riesa
country: Germany
facility: Gemeinschaftspraxis Herz Riesa
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Schwerin
country: Germany
facility: MVZ Schwerin West GmbH
city: Schwäbisch Hall
country: Germany
facility: Facharztpraxis für Kardiologie und Innere Medizin
city: Seehausen
country: Germany
facility: Nierenzentrum Altmark
city: Siegen
country: Germany
facility: Zentrum für Prävention und Rehabilitation
city: Singen
country: Germany
facility: Klinik Singen
city: Sonneberg
country: Germany
facility: MEDINOS Klinik Sonneberg
city: Straubing
country: Germany
facility: Kardiologische Praxis im Steiner Thor
city: Straubing
country: Germany
facility: Praxis Dr Knöbel u. Partner
city: Strausberg
country: Germany
facility: Praxis Dr. Michael Rother
city: Trier
country: Germany
facility: Diabetologische Schwerpunktpraxis
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Ulm
country: Germany
facility: Studienzentrum der Herzklinik Ulm GbR
city: Unterwellenborn
country: Germany
facility: Praxis Dr. Hansen
city: Ursensollen
country: Germany
facility: Praxis Dr. Dengler/Hohenstatt
city: Völklingen
country: Germany
facility: Herzzentrum Saar
city: Weinheim
country: Germany
facility: GRN Weinheim
city: Wermsdorf
country: Germany
facility: Kardiologische Praxis Al-Zoebi
city: Weyhe
country: Germany
facility: Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße
city: Witten
country: Germany
facility: Forschungszentrum-Ruhr / KliFoCenter GmbH
city: Wolmirstedt
country: Germany
facility: Kardiologische Fachpraxis
city: Wuppertal
country: Germany
facility: Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zwiesel
country: Germany
facility: Gemeinschaftspraxis am Angerbrunnen
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Generale Regionale "F. Miulli"
city: Agrigento
country: Italy
facility: P.O. Agrigento Ospedale San Giovanni di Dio
city: Ancona
country: Italy
facility: IRCCS-INRCA Ancona
city: Anzio
country: Italy
facility: Ospedale di Anzio
city: Ariccia
country: Italy
facility: Ospedale dei Castelli
city: Ascoli Piceno
country: Italy
facility: Ospedale "C. e G. Mazzoni"
city: Avellino
country: Italy
facility: A.O. San Giuseppe Moscati
city: Avezzano
country: Italy
facility: Ospedale SS Nicola e Filippo
city: Bari
country: Italy
facility: Ospedale S. Paolo
city: Bari
country: Italy
facility: A.O.U. Consorziale - Policlinico Bari
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08016
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08017
city: Benevento
country: Italy
facility: Azienda Ospedaliera S. Pio presidio G. Rummo
city: Bentivoglio
country: Italy
facility: AUSL Bologna Ospedale di Bentivoglio
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Ospedale Maggiore Carlo Alberto Pizzardi
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Bologna-Malpighi
city: Bolzano
country: Italy
facility: Ospedale di Bolzano - Site 08070
city: Bolzano
country: Italy
facility: Ospedale di Bolzano - Site 08112
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Casale Monferrato
country: Italy
facility: Ospedale Santo Spirito Casale Monferrato
city: Caserta
country: Italy
facility: A.O. S. Anna e S. Sebastiano
city: Castelfranco Veneto
country: Italy
facility: ULLS 2 MARCA TREVIGIANA Ospedale di Castelfranco Veneto
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele Presidio Ospedaliero Gaspare Rodolico
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Catanzaro
country: Italy
facility: L'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
city: Cava Dè Tirreni
country: Italy
facility: Ospedale Civile Santa Maria Incoronata dell'Olmo
city: Chieti
country: Italy
facility: Policlinico SS. Annunziata
city: Ciriè
country: Italy
facility: ASL TO4 Presidio Riunito di Ciriè-Lanzo
city: Cona
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara "Arcispedale Sant'Anna"
city: Coppito
country: Italy
facility: Ospedale San Salvatore
city: Firenze
country: Italy
facility: Ospedale Santa Maria Nuova
city: Firenze
country: Italy
facility: AOU Careggi - Site 08067
city: Firenze
country: Italy
facility: AOU Careggi - Site 08081
city: Firenze
country: Italy
facility: AOU Careggi - Site 08090
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria "Ospedali Riuniti" di Foggia
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Genova
country: Italy
facility: Presidio Ospedaliero S.O. Padre Antero Micone
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
city: La Spezia
country: Italy
facility: Ospedale Sant'Andrea
city: Lamezia Terme
country: Italy
facility: ASP Catanzaro Presidio Ospedaliero "Giovanni Paolo II"
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
city: Matera
country: Italy
facility: Presidio Ospedaliero "Madonna delle Grazie"
city: Melfi
country: Italy
facility: Presidio ospedaliero San Giovanni di Dio
city: Messina
country: Italy
facility: A.O.U. Policlinico "G. Martino"
city: Mestre
country: Italy
facility: ULSS 3 SERENISSIMA Ospedale dell'Angelo
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08039
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08097
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milano
country: Italy
facility: Ospedale San Luca - Gruppo Istituto Auxologico Italiano
city: Milano
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Ospedale Niguarda
city: Mirano
country: Italy
facility: ULSS 3 Serenissima Presidio Ospedaliero di Mirano
city: Modena
country: Italy
facility: AOU Modena Policlinico Modena
city: Napoli
country: Italy
facility: A.O.R.N. Antonio Cardarelli
city: Napoli
country: Italy
facility: A.O.R.N. MONALDI OSPEDALE DEI COLLI Ospedale Monaldi
city: Napoli
country: Italy
facility: A.O.U. Federico Ii
city: Napoli
country: Italy
facility: Azienda Ospedaliera Specialistica dei Colli Ospedale Monaldi
city: Napoli
country: Italy
facility: Policlinico Università Federico II - Napoli
city: Nocera Inferiore
country: Italy
facility: Ospedale Umberto I
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara
city: Novi Ligure
country: Italy
facility: Ospedale San Giacomo
city: Padova
country: Italy
facility: Azienda ospedaliera-Università di Padova
city: Palermo
country: Italy
facility: A.O.U. Policlinico "P. Giaccone"
city: Palermo
country: Italy
facility: Casa di Cura Triolo Zancla Hospital
city: Pavia
country: Italy
facility: ICS Maugeri
city: Perugia
country: Italy
facility: USL Umbria I
city: Perugia
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia di Perugia
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Pisa
country: Italy
facility: Fondazione Monasterio
city: Portogruaro
country: Italy
facility: P. O. Portogruaro
city: Potenza
country: Italy
facility: Azienda Ospedaliera Regionale San Carlo di Potenza
city: Prato
country: Italy
facility: Nuovo Ospedale Santo Stefano
city: Ragusa
country: Italy
facility: Azienda Sanitaria Provinciale di Ragusa Ospedale Giovanni Paolo II
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Rho
country: Italy
facility: ASST Rhodense - Ospedale di Circolo di Rho
city: Rieti
country: Italy
facility: Ospedale San Camillo De Lellis
city: Rimini
country: Italy
facility: Ospedale Infermi AUSL Romagna
city: Rivoli
country: Italy
facility: Ospedale degli Infermi di Rivoli
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08046
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08121
city: Roma
country: Italy
facility: Policlinico Casilino
city: Roma
country: Italy
facility: AOU S. Andrea
city: Salerno
country: Italy
facility: A.O. San Giovanni di Dio e Ruggi D'Aragona
city: Saronno
country: Italy
facility: ASST Valle Olona P.O. Saronno
city: Sarzana
country: Italy
facility: Ospedale S. Bartolomeo
city: Sassari
country: Italy
facility: AOU Sassari Ospedale SS. Annunziata
city: Sesto San Giovanni
country: Italy
facility: IRCCS Multimedica
city: Siena
country: Italy
facility: A.O.U. Senese Ospedale Santa Maria alle Scotte
city: Siena
country: Italy
facility: AOU Senese- Policlinico Le Scotte
city: Taranto
country: Italy
facility: Casa di cura Villa Verde
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
city: Torino
country: Italy
facility: Ospedale Mauriziano Presidio Umberto I
city: Torrette
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Treviso
country: Italy
facility: ULLS 2 MARCA TREVIGIANA Ospedale Ca' Foncello
city: Trieste
country: Italy
facility: Ospedale di Cattinara
city: Udine
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Urbino
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Varese
country: Italy
facility: ASST Settelaghi Ospedale di Circolo e Fondazione Macchi
city: Verbania
country: Italy
facility: Ospedale Castelli Verbania
city: Almelo
country: Netherlands
facility: ZGT
city: Amersfoort
country: Netherlands
facility: Meander Mc
city: Amsterdam
country: Netherlands
facility: AUMC
city: Amsterdam
country: Netherlands
facility: Mc Leeuwarden
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: AMPHIA
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer
city: Ede
country: Netherlands
facility: ZGV
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Gouda
country: Netherlands
facility: GHZ
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Hardenberg
country: Netherlands
facility: Saxenburgh Medisch Centrum
city: Hilversum
country: Netherlands
facility: Tergooi Mc
city: Hoogeveen
country: Netherlands
facility: Treant Bethesda Hoogeveen
city: Hoorn
country: Netherlands
facility: Dijklander
city: Leeuwarden
country: Netherlands
facility: BOVEN IJ
city: Leiderdorp
country: Netherlands
facility: ALRIJNE
city: Maastricht
country: Netherlands
facility: MUMC+
city: Rotterdam
country: Netherlands
facility: Erasmus Mc
city: Rotterdam
country: Netherlands
facility: MAASSTAD
city: Tiel
country: Netherlands
facility: SKB
city: Winterswijk
country: Netherlands
facility: ZRT
city: Zwolle
country: Netherlands
facility: Isala Zwolle
city: A Coruña
country: Spain
facility: Hospital Abente y Lago
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Alcoi
country: Spain
facility: Hospital Virgen de los Lirios
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Almeria
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Asturias
country: Spain
facility: Hospital Universitario Central de Asturias
city: Asturias
country: Spain
facility: Clínica Mapfre Salud Gijón
city: Asturias
country: Spain
facility: Hospital Universitario San Agustin
city: Asturias
country: Spain
facility: Hospital Vital Álvarez-Buylla
city: Bacelona
country: Spain
facility: Hospital Vall d'Hebron
city: Badajoz
country: Spain
facility: Hospital Universitario Nuestra Señora del Perpetuo Socorro
city: Badalona, Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínico de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Castellón de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Coslada, Madrid
country: Spain
facility: Hospital del Henares
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Denia
country: Spain
facility: Hospital de Denia
city: Donostia
country: Spain
facility: Hospital UNiversitario de Donostia
city: Fuenlabrada Madrid
country: Spain
facility: Hospital de Fuenlabrada
city: Gijon
country: Spain
facility: Hospital Universitario de Cabueñes
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Hospital Universitario Médico-Quirúrgico de Jaén
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: La Coruña
country: Spain
facility: Hospital San Rafael
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrín
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria
city: León
country: Spain
facility: Hospital Universitario de León
city: Lleida
country: Spain
facility: HOSPITAL UNIVERSITARi ARNAU DE VILANOVA
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Central de la Defensa Gómez-Ulla
city: Madrid
country: Spain
facility: Hospital HM Montepríncipe
city: Madrid
country: Spain
facility: Hospital Universitario de Torrejón
city: Majadahonda Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Majdahonda Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Malaga
country: Spain
facility: Consulta de Cardiología Dr. Javier Mora Robles
city: Marbella Málaga
country: Spain
facility: Hospital Costa del Sol
city: Mendaro
country: Spain
facility: Hospital de Mendaro
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son LLatzer
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Port De Sagunt
country: Spain
facility: Hospital de Sagunto
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan
city: Sabadell, Barcelona
country: Spain
facility: Corporación Sanitaria Parc Taulí
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Salt, Girona
country: Spain
facility: Hospital Santa Caterina
city: Sant Joan Despi, Barcelona
country: Spain
facility: Complexe hospitalari Moisès Broggi
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Vírgen del Rocío
city: Soria
country: Spain
facility: Complejo Asistencial Universitario de Soria
city: Tarragona
country: Spain
facility: Hospital de Sant Pau i Santa Tecla
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Terrassa Barcelona
country: Spain
facility: Hospital Universitario Mútua de Terrassa
city: Toledo
country: Spain
facility: Hospital General Universitario de Toledo
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Vithas Valencia 9 de Octubre
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Vigo Pontevedra
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitaro Lozano Blesa
city: Baden
country: Switzerland
facility: Diabetologie & Endokrinologie Baden
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
city: Binningen
country: Switzerland
facility: Praxis Dr. med Urs Beat Gröflin
city: Davos
country: Switzerland
facility: Hochgebirgsklinik Davos
city: Frauenfeld
country: Switzerland
facility: Schlossberg Ärztezentrum Frauenfeld
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lachen
country: Switzerland
facility: Spital Lachen AG
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: Lausanne
country: Switzerland
facility: University of Lausanne
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Lugano
country: Switzerland
facility: EOC Ente Ospedaliero Cantonale
city: Lugano
country: Switzerland
facility: MIP Associazione Medico in Pratica c/o Studio Medico Cardiologico Acquistapace
city: Olten
country: Switzerland
facility: Praxis Prof. Dr. med. Gottfried Rudofsky
city: Rennaz
country: Switzerland
facility: HÔPITAL RIVIERA-CHABLAIS, VAUD-VALAIS, Centre hospitalier de Rennaz
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Thun
country: Switzerland
facility: Spital Thun
city: Yverdon-les-Bains
country: Switzerland
facility: Prof. Dr. med. Stephane Bosquet
city: Zürich
country: Switzerland
facility: Diagnostisches und Therapeutisches Herzzentrum
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
city: Belfast
country: United Kingdom
facility: South Eastern Ulster Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Chippenham
country: United Kingdom
facility: Rowden Surgery
city: Craigavon
country: United Kingdom
facility: Craigavon Area Hospital
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: Darlington
country: United Kingdom
facility: Carmel Medical Practice
city: Dartford
country: United Kingdom
facility: Dartford and Gravesham NHS Trust Darent Valley Hospital
city: Durham
country: United Kingdom
facility: University Hospital North Durham
city: Essex
country: United Kingdom
facility: Southend University Hospital
city: Hampshire
country: United Kingdom
facility: Oaks Healthcare
city: Kendal
country: United Kingdom
facility: West Morland General Hospital
city: Leicester
country: United Kingdom
facility: North Blaby PCN
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust/ QMUL
city: London
country: United Kingdom
facility: Freuchen Medical Centre
city: London
country: United Kingdom
facility: Royal Free Hospital Lipid Clinic
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Imperial College London
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Middlesbrough
country: United Kingdom
facility: STRIVE, The James Cook University Hospital
city: Northumbria
country: United Kingdom
facility: North Tees Hospital
city: Nottingham
country: United Kingdom
facility: City Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital Lipid Clinic
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Prescot
country: United Kingdom
facility: Whiston Hospital
city: Salford
country: United Kingdom
facility: North Manchester General Hospital
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
city: Staffordshire
country: United Kingdom
facility: Queen's Hospital Lipid Clinic
city: Telford
country: United Kingdom
facility: Princess Royal Hospital
city: Torquay
country: United Kingdom
facility: Torbay and South Devon NHS Foundation Trust
city: Trowbridge
country: United Kingdom
facility: Trowbridge Health Centre
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wales
country: United Kingdom
facility: North Wales Cardiac Centre
city: Wansford
country: United Kingdom
facility: Wansford and Kings Cliffe Practice
city: Watford
country: United Kingdom
facility: Bridgewater Surgeries
city: Watford
country: United Kingdom
facility: Sheepcot Medical Centre
Study officials:
affiliation: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: