Hypercholesterolemia Clinical Trial
— MILOSOfficial 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)
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Austria | Dr. Armin Öhlinger Kardiologe & innere Medizin | Dornbirn | |
Austria | Landeskrankenhaus Feldkirch | Feldkirch | |
Austria | Institut für Herz- und Gefäßerkrankungen GmbH | Graz | |
Austria | LKH-Univ. Klinikum Graz | Graz | |
Austria | Medizinische Universität Graz | Graz | |
Austria | Internist Dr. med. univ. Stefan Moser | Horsching | |
Austria | Medizinische Universität Innsbruck | Innsbruck | |
Austria | KABEG Klinikum Klagenfurt am Wörthersee | Klagenfurt am Worthersee | |
Austria | Konventhospital der Barmherzigen Brüder Linz | Linz | |
Austria | Ordination Dr. Johannes Föchterle | Linz | |
Austria | Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl | Mattersburg | |
Austria | Landesklinikum Melk | Melk | |
Austria | Kompetenz-Zentrum Diabetes | Salzburg | |
Austria | Ordination Universitätsdozent Dr. Alexander Kober | Sankt Aegyd Am Neuwalde | |
Austria | Ordination Dr. med. univ. Evelyn Fließer-Görzer | Sankt Stefan Ob Stainz | |
Austria | Landeskrankenhaus Villach | Villach | |
Austria | Allgemeines Krankenhaus der Stadt Wien | Wien | |
Austria | Herz Zentrum Währing | Wien | |
Austria | Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung | Wien | |
Austria | Klinik Hietzing, Wiener Gesundheitsverbund | Wien | |
Austria | Ordination Dr. Thomas Maca | Wien | |
Austria | Schnürer & Fritsch - Gruppenpraxis für Innere Medizin | Wien | |
Austria | Zentrum für Klinische Studien Dr. Hanusch GmbH | Wien | |
Belgium | ASZ | Aalst | |
Belgium | Epicura Hornu | Boussu | |
Belgium | A.Z. KLINA Brasschaat | Brasschaat | |
Belgium | CHU Brugman | Bruxelles | |
Belgium | Clinique de l'Europe Saint Elisabeth | Bruxelles | |
Belgium | Clinique Saint-Jean Bruxelles | Bruxelles | |
Belgium | CUB-Hôpital Erasme | Bruxelles | |
Belgium | UCL Saint-Luc Woluwé Bruxelles | Bruxelles | |
Belgium | UZ Brussel | Bruxelles | |
Belgium | Private Practice | Ciney | |
Belgium | Az Sint Blazius | Dendermonde | |
Belgium | UZ Antwerpen | Edegem | |
Belgium | Z.O.L - Campus St. Jan | Genk | |
Belgium | AZ St-Lucas & Volkskliniek | Ghent | |
Belgium | UZ Gent | Ghent | |
Belgium | GHDC Charleroi - Site Hôpital Saint-Joseph | Gilly | |
Belgium | Private Practice | Gribomont | |
Belgium | Pôle hospitalier Jolimont | Haine-Saint-Paul | |
Belgium | BVBA Med Kab | Halen | |
Belgium | Jessa Ziekenhuis | Hasselt | |
Belgium | CHR Huy | Huy | |
Belgium | JAN YPERMAN Ziekenhuis | Ieper | |
Belgium | AZ Groeninge Kortrijk | Kortrijk | |
Belgium | CHU Tivoli | La Louvière | |
Belgium | UZ Leuven | Leuven | |
Belgium | CHR Citadelle de Liège | Liège | |
Belgium | CHU Charleroi Hopital civil Marie-Curie | Lodelinsart | |
Belgium | CHU Mons Ambroise Paré | Mons | |
Belgium | AZ Sint Jan | Oostende | |
Belgium | AZ Delta | Roeselare | |
Belgium | AZ Glorieux | Ronse | |
Belgium | Sint Trudo | Sint Truiden | |
Belgium | Sint-Andriesziekenhuis Tielt | Tielt | |
Belgium | Private Practice | Tienen | |
Belgium | CHU UCL Mont-Godinne | Yvoir | |
Germany | MVZ Helios Aue | Aue | |
Germany | Kardiologische Praxis Enders | Bad Elster | |
Germany | Kardiologische Praxis | Bad Homburg | |
Germany | Universitätsklinikum Freiburg - Universitäts-Herzzentrum | Bad Krozingen | |
Germany | Praxis am Landratspark | Bad Segeberg | |
Germany | CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel | Bamberg | |
Germany | Kardiologische Praxis | Bechhofen | |
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Diabetespraxis Dr. Braun | Berlin | |
Germany | Dres. Seeger & Partner | Berlin | |
Germany | Herzpraxis Berlin MVZ | Berlin | |
Germany | Lipidambulanz Charite | Berlin | |
Germany | Praxis Rankestraße | Berlin | |
Germany | Praxiszentrum Biedenkopf | Biedenkopf | |
Germany | Praxis Dr. A. Biedermann | Blankenhain | |
Germany | MVZ für Innere Medizin | Bonn | |
Germany | Kardiologie im Friedrichspalast Bruchsal | Bruchsal | |
Germany | Studiengesellschaft Könemann und Steinmann GbR | Bunde | |
Germany | MediClin Reha-Zentrum Spreewald | Burg | |
Germany | Kardiologische Praxis Stellmach | Chemnitz | |
Germany | MVZ am Küchwald | Chemnitz | |
Germany | MVZ Polymed | Chemnitz | |
Germany | Praxis Dr. Menzel | Dessau | |
Germany | Klinikum Lippe GmbH | Detmold | |
Germany | Kardiologische Gemeinschaftspraxis | Dortmund | |
Germany | Cardiologicum Dresden/Pirna | Dresden | |
Germany | Dres. Günther/Kolschmann | Dresden | |
Germany | Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden | Dresden | |
Germany | Universitätsklinikum Carl Gustav Carus | Dresden | |
Germany | DZDM Diabeteszentrum Duisburg Mitte | Duisburg | |
Germany | Nierenzentrum Düren | Düren | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | Praxis Dilltal | Ehringshausen | |
Germany | Praxis Dipl. -Med. Petra Herrmann | Eisenach | |
Germany | Kardiologische Praxis | Elsterwerda | |
Germany | Gemeinschaftspraxis ISP Erlangen | Erlangen | |
Germany | Hausarztzentrum am Germaniaplatz | Essen | |
Germany | DIAKO Flensburg | Flensburg | |
Germany | Praxis für Nieren und Hochdruck-Krankheiten | Flensburg | |
Germany | MVZ Altstadt-Carree Fulda | Fulda | |
Germany | Praxis Dr. Langel | Gera | |
Germany | Praxis für Gefäßmedizin | Görlitz | |
Germany | Universitätsmedizin Göttingen | Göttingen | |
Germany | Praxis Dr. Müller | Gräfenhainichen | |
Germany | Universitätsmedizin Greifswald | Greifswald | |
Germany | Evangelisches Krankenhaus Hagen-Haspe | Hagen | |
Germany | Praxis | Hainburg | |
Germany | Cardiologicum Hamburg - Praxis Wandsbek | Hamburg | |
Germany | Diabetes Zentrum Wandsbeck | Hamburg | |
Germany | Kardiologie am Tibarg | Hamburg | |
Germany | MVZ Prof. Mathey, Prof. Schofer | Hamburg | |
Germany | Kardiologie List | Hannover | |
Germany | Kardiologische Praxis | Haßloch | |
Germany | Kardiologische Schwerpunktpraxis | Heidelberg | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Praxis Heik/Wedig | Heiligenstadt | |
Germany | KARDIO-IN Kardiologische Gemeinschaftspraxis | Ingolstadt | |
Germany | Kardiologische Praxis | Kaiserslautern | |
Germany | SRH Klinikum Karlsbad-Langensteinbach | Karlsbad | |
Germany | B. Braun Ambulantes Herzzentrum Kassel | Kassel | |
Germany | Praxis Dr. Heiner Müller | Katzhütte | |
Germany | Nephrologie Kiel | Kiel | |
Germany | Gemeinschaftsklinikum Mittelrhein | Koblenz | |
Germany | IKAPP | Köln | |
Germany | Zentrum für klinische Forschung | Köln | |
Germany | Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz | Konstanz | |
Germany | Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann | Kornwestheim | |
Germany | Kardiologische Praxis Kyritz | Kyritz | |
Germany | Kardiologische Praxis Boudriot | Leipzig | |
Germany | MVZ Stoffwechselmedizin Leipzig | Leipzig | |
Germany | Universitätsklinikum Leipzig | Leipzig | |
Germany | Praxis Dr. I.Simon-Wagner | Lichtenfels | |
Germany | St. Vincenz Krankenhaus | Limburg | |
Germany | Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet | Lohne | |
Germany | Cardio Centrum Ludwigsburg-Bietigheim | Ludwigsburg | |
Germany | Kardiologische Praxisklinik Ludwigshafen | Ludwigshafen | |
Germany | Universität zu Lübeck | Luebeck | |
Germany | Kardiologische Praxis Tamm/Hoh | Lutherstadt Wittenberg | |
Germany | Institut für Präventive Medizin & Klinische Forschung GbR | Magdeburg | |
Germany | Cardiopraxis Mainz | Mainz | |
Germany | Katholisches Klinikum Mainz | Mainz | |
Germany | Universitätsklinikum Mainz | Mainz | |
Germany | UMM Mannheim | Mannheim | |
Germany | ZE:RO Praxen | Mannheim | |
Germany | Kardiologische Praxis | Markkleeberg | |
Germany | Praxis Ben-Chur | Meiningen | |
Germany | Praxis Haj-Yehia | Moers | |
Germany | Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte | Mühldorf | |
Germany | Kardiologie Mühldorf am Inn | Mühldorf | |
Germany | Herzquartier Mülheim | Mülheim an der Ruhr | |
Germany | Dres. Wauer/Windstetter | München | |
Germany | Kardiologie Neuhausen-Nymphenburg | München | |
Germany | Praxis für Innere Medizin Münster | Münster | |
Germany | Praxis Kiepenkerl | Münster | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Zentrum für Kardiologie an der Raphaelsklinik Münster | Münster | |
Germany | Internistische Praxisgemeinschaft | Neu Isenburg | |
Germany | Hausarztpraxis | Oer-Erkenschwick | |
Germany | St. Vincenz-Krankenhaus GmbH | Paderborn | |
Germany | Kardiologische Praxis Papenburg - Site 6071 | Papenburg | |
Germany | Kardiologische Praxis Papenburg - Site 6072 | Papenburg | |
Germany | Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan | Passau | |
Germany | Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH | Pirna | |
Germany | Kardiologische Gemeinschaftspraxis | Potsdam | |
Germany | VieSante Herzmedizin Potsdam | Potsdam | |
Germany | Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann | Radebeul | |
Germany | Gemeinschaftspraxis Herz Riesa | Riesa | |
Germany | Universitätsmedizin Rostock | Rostock | |
Germany | Facharztpraxis für Kardiologie und Innere Medizin | Schwäbisch Hall | |
Germany | MVZ Schwerin West GmbH | Schwerin | |
Germany | Klinik Singen | Singen | |
Germany | MEDINOS Klinik Sonneberg | Sonneberg | |
Germany | Kardiologische Praxis im Steiner Thor | Straubing | |
Germany | Praxis Dr Knöbel u. Partner | Straubing | |
Germany | Praxis Dr. Michael Rother | Strausberg | |
Germany | Diabetologische Schwerpunktpraxis | Trier | |
Germany | Krankenhaus der Barmherzigen Brüder Trier | Trier | |
Germany | Studienzentrum der Herzklinik Ulm GbR | Ulm | |
Germany | Praxis Dr. Hansen | Unterwellenborn | |
Germany | Herzzentrum Saar | Völklingen | |
Germany | GRN Weinheim | Weinheim | |
Germany | Kardiologische Praxis Al-Zoebi | Wermsdorf | |
Germany | Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße | Weyhe | |
Germany | Kardiologische Fachpraxis | Wolmirstedt | |
Germany | Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue | Wuppertal | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Germany | Gemeinschaftspraxis am Angerbrunnen | Zwiesel | |
Italy | Ospedale Generale Regionale "F. Miulli" | Acquaviva Delle Fonti | |
Italy | P.O. Agrigento Ospedale San Giovanni di Dio | Agrigento | |
Italy | IRCCS-INRCA Ancona | Ancona | |
Italy | Ospedale di Anzio | Anzio | |
Italy | Ospedale dei Castelli | Ariccia | |
Italy | Ospedale "C. e G. Mazzoni" | Ascoli Piceno | |
Italy | P.O. ''E. Muscatello'' | Augusta | |
Italy | A.O. San Giuseppe Moscati | Avellino | |
Italy | Ospedale SS Nicola e Filippo | Avezzano | |
Italy | A.O.U. Consorziale - Policlinico Bari | Bari | |
Italy | Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08016 | Bari | |
Italy | Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08017 | Bari | |
Italy | Ospedale S. Paolo | Bari | |
Italy | Azienda Ospedaliera S. Pio presidio G. Rummo | Benevento | |
Italy | AUSL Bologna Ospedale di Bentivoglio | Bentivoglio | |
Italy | ASST Papa Giovanni XXIII | Bergamo | |
Italy | Ospedale Maggiore Carlo Alberto Pizzardi | Bologna | |
Italy | Policlinico Sant'Orsola Bologna-Malpighi | Bologna | |
Italy | Ospedale di Bolzano - Site 08070 | Bolzano | |
Italy | Ospedale di Bolzano - Site 08112 | Bolzano | |
Italy | Spedali Civili di Brescia | Brescia | |
Italy | ASSL Cagliari Ospedale Binaghi | Cagliari | |
Italy | Ospedale Santo Spirito Casale Monferrato | Casale Monferrato | |
Italy | A.O. S. Anna e S. Sebastiano | Caserta | |
Italy | ULLS 2 MARCA TREVIGIANA Ospedale di Castelfranco Veneto | Castelfranco Veneto | |
Italy | AOU Policlinico Vittorio Emanuele Presidio Ospedaliero Gaspare Rodolico | Catania | |
Italy | Azienda Ospedaliera Cannizzaro | Catania | |
Italy | L'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro | Catanzaro | |
Italy | Ospedale Civile Santa Maria Incoronata dell'Olmo | Cava Dè Tirreni | |
Italy | Policlinico SS. Annunziata | Chieti | |
Italy | ASL TO4 Presidio Riunito di Ciriè-Lanzo | Ciriè | |
Italy | Azienda Ospedaliero-Universitaria di Ferrara "Arcispedale Sant'Anna" | Cona | |
Italy | Ospedale San Salvatore | Coppito | |
Italy | ASST Cremona - Ospedale di Cremona | Cremona | |
Italy | AOU Careggi - Site 08067 | Firenze | |
Italy | AOU Careggi - Site 08081 | Firenze | |
Italy | AOU Careggi - Site 08090 | Firenze | |
Italy | Ospedale Santa Maria Nuova | Firenze | |
Italy | Azienda Ospedaliera Universitaria "Ospedali Riuniti" di Foggia | Foggia | |
Italy | Ospedale Dono Svizzero | Formia | |
Italy | Ospedale Fabrizio Spaziani | Frosinone | |
Italy | Ospedale Policlinico San Martino | Genova | |
Italy | Presidio Ospedaliero S.O. Padre Antero Micone | Genova | |
Italy | Ospedale della Misericordia | Grosseto | |
Italy | Ospedale Sant'Andrea | La Spezia | |
Italy | ASP Catanzaro Presidio Ospedaliero "Giovanni Paolo II" | Lamezia Terme | |
Italy | Ospedale Vito Fazzi | Lecce | |
Italy | Ospedale Mater Salutis | Legnago | |
Italy | Presidio Ospedaliero "Madonna delle Grazie" | Matera | |
Italy | Presidio ospedaliero San Giovanni di Dio | Melfi | |
Italy | A.O.U. Policlinico "G. Martino" | Messina | |
Italy | ULSS 3 SERENISSIMA Ospedale dell'Angelo | Mestre | |
Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | |
Italy | Centro Cardiologico Monzino | Milano | |
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08039 | Milano | |
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08097 | Milano | |
Italy | IRCCS Ospedale Galeazzi-Sant'Ambrogio | Milano | |
Italy | IRCCS Ospedale Galeazzi-Sant'Ambrogio -area MIND (ex area EXPO) | Milano | |
Italy | IRCCS Ospedale Galeazzi-Sant'Ambrogio -area MIND (ex area EXPO) | Milano | |
Italy | Ospedale Niguarda | Milano | |
Italy | Ospedale San Luca - Gruppo Istituto Auxologico Italiano | Milano | |
Italy | ULSS 3 Serenissima Presidio Ospedaliero di Mirano | Mirano | |
Italy | AOU Modena Policlinico Modena | Modena | |
Italy | Ospedale Civile di Baggiovara | Modena | |
Italy | A.O.R.N. Antonio Cardarelli | Napoli | |
Italy | A.O.R.N. MONALDI OSPEDALE DEI COLLI Ospedale Monaldi | Napoli | |
Italy | A.O.U. Federico Ii | Napoli | |
Italy | Azienda Ospedaliera Specialistica dei Colli Ospedale Monaldi | Napoli | |
Italy | Policlinico Università Federico II - Napoli | Napoli | |
Italy | Ospedale Umberto I | Nocera Inferiore | |
Italy | AOU Maggiore della Carità di Novara | Novara | |
Italy | Ospedale San Giacomo | Novi Ligure | |
Italy | Azienda ospedaliera-Università di Padova | Padova | |
Italy | A.O.U. Policlinico "P. Giaccone" | Palermo | |
Italy | Casa di Cura Triolo Zancla Hospital | Palermo | |
Italy | ICS Maugeri | Pavia | |
Italy | Azienda Ospedaliera S. Maria della Misericordia di Perugia | Perugia | |
Italy | USL Umbria I | Perugia | |
Italy | Ospedale Guglielmo da Saliceto | Piacenza | |
Italy | Fondazione Monasterio | Pisa | |
Italy | P. O. Portogruaro | Portogruaro | |
Italy | Azienda Ospedaliera Regionale San Carlo di Potenza | Potenza | |
Italy | Nuovo Ospedale Santo Stefano | Prato | |
Italy | Azienda Sanitaria Provinciale di Ragusa Ospedale Giovanni Paolo II | Ragusa | |
Italy | Ospedale Santa Maria delle Croci | Ravenna | |
Italy | ASST Rhodense - Ospedale di Circolo di Rho | Rho | |
Italy | Ospedale San Camillo De Lellis | Rieti | |
Italy | Ospedale Infermi AUSL Romagna | Rimini | |
Italy | Ospedale degli Infermi di Rivoli | Rivoli | |
Italy | AOU S. Andrea | Roma | |
Italy | Azienda Ospedaliera San Giovanni Addolorata | Roma | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08046 | Roma | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08121 | Roma | |
Italy | Ospedale Sandro Pertini | Roma | |
Italy | Policlinico Casilino | Roma | |
Italy | Policlinico Tor Vergata | Roma | |
Italy | Policlinico Umberto I | Roma | |
Italy | A.O. San Giovanni di Dio e Ruggi D'Aragona | Salerno | |
Italy | ASST Valle Olona P.O. Saronno | Saronno | |
Italy | Ospedale S. Bartolomeo | Sarzana | |
Italy | AOU Sassari Ospedale SS. Annunziata | Sassari | |
Italy | IRCCS Multimedica | Sesto San Giovanni | |
Italy | A.O.U. Senese Ospedale Santa Maria alle Scotte | Siena | |
Italy | AOU Senese- Policlinico Le Scotte | Siena | |
Italy | Casa di cura Villa Verde | Taranto | |
Italy | Azienda Ospedaliera Santa Maria | Terni | |
Italy | Ospedale Mauriziano Presidio Umberto I | Torino | |
Italy | AOU Ospedali Riuniti di Ancona | Torrette | |
Italy | Ospedale Santa Chiara | Trento | |
Italy | ULLS 2 MARCA TREVIGIANA Ospedale Ca' Foncello | Treviso | |
Italy | Ospedale di Cattinara | Trieste | |
Italy | Ospedale Santa Maria della Misericordia | Udine | |
Italy | Ospedale Santa Maria della Misericordia | Urbino | |
Italy | ASST Settelaghi Ospedale di Circolo e Fondazione Macchi | Varese | |
Italy | Ospedale Castelli Verbania | Verbania | |
United Kingdom | Royal United Hospitals Bath NHS Foundation Trust | Bath | |
United Kingdom | South Eastern Ulster Hospital | Belfast | |
United Kingdom | University Hospital of Wales | Cardiff | |
United Kingdom | Rowden Surgery | Chippenham | |
United Kingdom | Craigavon Area Hospital | Craigavon | |
United Kingdom | Carmel Medical Practice | Darlington | |
United Kingdom | Darlington Memorial Hospital | Darlington | |
United Kingdom | Dartford and Gravesham NHS Trust Darent Valley Hospital | Dartford | |
United Kingdom | Southend University Hospital | Essex | |
United Kingdom | Oaks Healthcare | Hampshire | |
United Kingdom | North Blaby PCN | Leicester | |
United Kingdom | Lincoln County Hospital | Lincoln | |
United Kingdom | Barts Health NHS Trust/ QMUL | London | |
United Kingdom | Freuchen Medical Centre | London | |
United Kingdom | Imperial College London | London | |
United Kingdom | Royal Free Hospital Lipid Clinic | London | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | Wythenshawe Hospital | Manchester | |
United Kingdom | STRIVE, The James Cook University Hospital | Middlesbrough | |
United Kingdom | City Hospital | Nottingham | |
United Kingdom | Derriford Hospital Lipid Clinic | Plymouth | |
United Kingdom | North Manchester General Hospital | Salford | |
United Kingdom | Moorgreen Hospital | Southampton | |
United Kingdom | Queen's Hospital Lipid Clinic | Staffordshire | |
United Kingdom | Princess Royal Hospital | Telford | |
United Kingdom | Torbay and South Devon NHS Foundation Trust | Torquay | |
United Kingdom | Trowbridge Health Centre | Trowbridge | |
United Kingdom | Royal Cornwall Hospital | Truro | |
United Kingdom | North Wales Cardiac Centre | Wales | |
United Kingdom | Wansford and Kings Cliffe Practice | Wansford | |
United Kingdom | Bridgewater Surgeries | Watford | |
United Kingdom | Sheepcot Medical Centre | Watford |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company |
Austria, Belgium, Germany, Italy, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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) | |
Secondary | 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) | ||
Secondary | 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 | 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) | |
Secondary | 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 | 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) |
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