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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04579367
Other study ID # DSE-BMP-01-20-EU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date September 2025

Study information

Verified date September 2023
Source Daiichi Sankyo, Inc.
Contact Daiichi Sankyo Contact for Clinical Trial Information
Phone 908-992-6400
Email CTRinfo@dsi.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bempedoic acid and/or its fixed-dose combination with ezetimibe
This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  United Kingdom, 

Outcome

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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