DyslipidemiaSANTORININCT04271280
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
An observational study of Dyslipidemia and Cardiovascular Diseases, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 540 sites in 14 countries.
Trial summary
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia
- What is being tested?
- Non-interventional
- How many people
- 9,559 participants
- Where
- 540 sitesin 14 countries
- Study dates
- 17 Mar 2020to 11 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High risk and very high-risk participants requiring lipid-modifying therapies
Who may be able to join
- Very High Risk and High Risk dyslipidemic patients requiring LMTs
- Not simultaneously participating in any interventional study
- Providing written informed consent for participation in the study (Informed consent form)
- Life expectancy > 1 year
Who cannot join
- Not applicable; non-interventional study
Trial locations and contacts
540 sites in 14 countries.
540 sites in 14 countries
Germany139 sites
Downtown Clinic Aachen
Aachen, 52062
Kardiologische Praxis Aachen
Aachen, 52062
Praxis Delonge
Aachen, 52078
Kliniken an der Paar - Krankenhaus Aichach
Aichach, 86551
Oberpfalz Research GbR
Amberg, 92224
MVZ Aue
Aue, 08280
Kardiologische Praxis
Bad Elster, 08645
Kardiologische Praxis
Bad Homburg, 61348
Universitäts-Herz-Zentrum Freiburg-Bad Krozingen
Bad Krozingen, 79189
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, 61231
Herz - u. Diabeteszentrum NRW
Bad Oeynhausen, 32545
Praxis am Landratspark
Bad Segeberg, 23795
Gemeinschaftspraxis für Herz und Lunge
Bamberg, 96049
Kardiologische Praxis
Bechhofen, 66894
Diabetespraxis Prenzlauer Allee
Berlin, 10409
Praxis Rankestraße
Berlin, 10789
MVZ Dres. Ramdohr - Praxis für Cardiovascular und Ultraschalldiagnostik
Berlin, 12034
Praxis Dr. Matthias Claus
Berlin, 12559
Kardiologische Facharztpraxis Dr. Anne Winkelmann
Berlin, 13053
Charité Campus Virchow
Berlin, 13353
Vivantes Humboldt-Klinikum
Berlin, 13509
Vivantes Klinikum Spandau
Berlin, 13585
Marienhaus-Klinikum Eifel Bitburg
Bitburg, 54634
Städtisches Klinikum Brandenburg
Brandenburg an der Havel, 14770
Kardiologie an der Paulikirche
Braunschweig, 38102
Kardiologie im Friedrichspalast Bruchsal
Bruchsal, 76646
MediClin Reha-Zentrum Spreewald
Burg, 03096
MVZ am Küchwald
Chemnitz, 09113
Praxis Dipl.med Schermaul
Chemnitz, 09122
Kardiologische Praxis
Chemnitz, 09126
MVZ Polymed
Chemnitz, 09130
St. Josefs-Hospital Cloppenburg
Cloppenburg, 49661
Klinikum Coburg GmbH
Coburg, 96450
MVZ Gesundes Herz
Cologne, 51105
Praxis Dr. Menzel
Dessau, 06846
Klinikum Lippe GmbH
Detmold, 32756
Kardiologische Gemeinschaftspraxis
Dortmund, 44137
Sankt-Johannes-Hospital
Dortmund, 44137
Kardiologische Gemeinschaftspraxis Dres. Wetzel/Willgeroth
Dortmund, 44141
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, 01099
Praxis Dr. Methfessel
Dresden, 01159
Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH
Dresden, 01277
Studienzentrum Dr. Faulmann
Dresden, 01279
Dres. Günther/Kolschmann
Dresden, 01307
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Praxis Dres. Jänsch/Varnai
Dresden, 01309
Praxis Dipl. - Med. Petra Herrmann - Fachärztin für Innere Medizin
Eisenach, 99817
Kardiologische Praxis
Elsterwerda, 04910
Elisabeth Krankenhaus Essen
Essen, 45138
Universitätsklinikum Essen
Essen, 45147
Medizentrum Essen Borbeck
Essen, 45355
Klinikum Frankfurt Hoechst GmbH
Frankfurt, 65929
MVZ Altstadt-Carree Fulda GmbH
Fulda, 36037
Evangelisches Krankenhaus Gelsenkirchen
Gelsenkirchen, 45879
Kardiologische Praxis
Gera, 07551
Praxis für Gefäßmedizin
Görlitz, 02827
Kardiologische Praxis
Gotha, 99867
Universitätsmedizin Göttingen
Göttingen, 37075
Praxis für Herzkreislauferkrankungen Greiz
Greiz, 07973
Evangelisches Krankenhaus Hagen-Haspe
Hagen, 58135
Gemeinschaftspraxis Dres. J. Hintze und M. Grundner
Hainstadt, 63512
Cardiologicum Hamburg-Wandsbek
Hamburg, 22041
Kardiologie am Tibarg
Hamburg, 22459
MVZ Prof. Detlef Mathey, Prof. Schofer GmbH
Hamburg, 22527
Kardiologische Praxis
Hanover, 30559
Kardiologische Praxis
Haßloch, 67454
Kardiologische Schwerpunktpraxis
Heidelberg, 69115
Praxis für Angiologie und Hämatologie
Heidelberg, 69120
Uniklinikum Heidelberg
Heidelberg, 69120
Praxis
Homburg, 66424
Kardiologie Oberschwaben - Bodensee Herz- und Gefäßpraxis
Isny, 88316
Kardiologische Praxis
Jena, 07743
Kardiopraxis Schirmer
Kaiserslautern, 67655
Kardiologie/Internistenteam Kamen
Kamen, 59174
SRH Klinikum Karlsbad-Langensteinbach
Karlsbach, 76307
B. Braun Ambulantes Herzzentrum MVZ GmbH
Kassel, 34121
CC Cleve-Studiencenter
Kleve, 47533
Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz
Konstanz, 78464
Praxis für Innere Medizin / Kardiologie - Dr. med. E. Persicke / Dr. med. O. Scheuermann
Kornwestheim, 70806
Kardiologische Gemeinschaftspraxis
Leipzig, 04103
MediClin MVZ Leipzig
Leipzig, 04109
Praxis für Gefäßerkrankungen und Gerinnungsstörungen Leipzig
Leipzig, 04109
Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
Leipzig, 04249
MVZ Stoffwechselmedizin Leipzig
Leipzig, 04317
Universitätsklinikum Leipzig
Leipzig, 4103
Kardiologische Fachpraxis
Lengerich, 49525
Praxis Dr. med. Ilka Simon-Wagner
Lichtenfels, 96215
St. Vincenz-Krankenhaus
Limburg, 65549
Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet
Löhne, 32584
Kardiologische Praxis Lohne
Löhne, 49393
Klinikum Lüdenscheid
Lüdenscheid, 58515
Cardio Centrum Ludwigsburg-Bietigheim
Ludwigsburg, 71634
Kardiologische Praxisklinik Ludwigshafen
Ludwigshafen, 67071
Dres. Erdmann/Schütz/Sicken
Lünen, 44534
St.Vincenz - u. Elisabeth-Hospital
Mainz, 55131
Universitätsklinikum Mainz Site 6186
Mainz, 55131
Universitätsklinikum Mainz Site 6187
Mainz, 55131
zero Praxen Mannheim
Mannheim, 68165
Universitätsklinikum Mannheim
Mannheim, 68167
Kardiologische Praxis
Markkleeberg, 04416
Praxis Dr. Ben-Chur
Meiningen, 98617
Kardiologie-Praxis
Moers, 47441
Gemeinschaftspraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
Mühldorf, 84453
Herzquartier Mühlheim, Kardiologische Gemeinschaftspraxis Dres. med. A. Krapivsky & P. Kekes
Mühlheim, 45468
Zentrum für Diabetes und Gefäßerkrankungen Münster
Münster, 48145
Praxis für Innere Medizin
Münster, 48149
Universitätsklinikum Münster
Münster, 48149
Praxis für Innere Medizin und Angiologie
Nordhausen, 99734
Kardiologische Praxis Northeim
Northeim, 37154
Gemeinschaftspraxis Drs. Haggenmiller/Jeserich Kardiologie-Angiologie-Innere Medizin
Nuremberg, 90402
Kardiologie am Weißen Turm
Nuremberg, 90402
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098
Kardiologische Praxis
Panitzsch, 04451
Kardiologische Praxis Papenburg (Site 6097)
Papenburg, 26871
Kardiologische Praxis Papenburg (Site 6098)
Papenburg, 26871
Kardiologische Praxis
Pirmasens, 66954
Cardiologicum Dresden/Pirna
Pirna, 01796
Kardiologie Potsdam
Potsdam, 14471
Kardiologische Gemeinschaftspraxis Potsdam
Potsdam, 14471
Paracelsus-Harz-Klinik Bad Suderode
Quedlinburg, 06485
Drs. Bauer/Buresch/Kösler
Regensburg, 93059
Gemeinschaftspraxis Herz Riesa
Riesa, 01587
Universitätsmedizin Rostock
Rostock, 18057
Zentrum für Prävention und Rehabilitation
Siegen, 57072
Kardiologische Praxis
Stahnsdorf, 14532
Praxis Dr. Birkenhagen
Stollberg, 09366
Drs. Knoebel @ Partner
Straubing, 94315
Praxis Dr. Michael Rother
Strausberg, 15344
Diabetologische Schwerpunktpraxis
Trier, 54292
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292
Studienzentrum der Herzklinik Ulm GbR
Ulm, 89077
Praxis Dr. Sabine Hansen
Unterwellenborn, 07333
Praxis für Prävention und Therapie
Villingen-Schwenningen, 78048
SHG Klinik Völklingen
Völklingen, 66333
GRN Klinik Weinheim
Weinheim, 69469
Forschungszentrum-Ruhr KliFoCenter GmbH
Witten, 58455
Klinikum Worms
Worms, 67550
Praxis Dr. Woitek
Wurzen, 04808
Praxis T. Schwarz
Zwenkau, 04442
Italy85 sites
INRCA -Ospedale U. Sestilli di Ancona
Ancona, The Marches, 60124
Ospedali Riuniti "Umberto I - Lancisi - Salesi
Ancona, The Marches, 60126
ASL Roma 6 - Ospedali Riuniti Anzio - Nettuno
Anzio, Lazio, 00042
Ospedale di Arzignano
Arzignano, Veneto, 36071
Presidio ospedaliero Cardinal Massaia - A.S.L. AT (SOC Diabetologia e Malattie Metaboliche)
Asti, Piedmont, 14100
A.O. San Giuseppe Moscati (U.O.C. Cardiologia/UTIC)
Avellino, Campania, 83100
A.O. San Giuseppe Moscati
Avellino, Campania, 83100
Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli"
Bari, Apulia, 70021
A.O.U. Consorziale - Policlinico Bari (Dipartimento di Medicina Interna)
Bari, Apulia, 70124
A.O.U. Consorziale - Policlinico Bari
Bari, Apulia, 70124
A.O.R.N. San Pio - P.O. RUMMO
Benevento, Campania, 82100
Ospedale di Bentivoglio
Bentivoglio, Emilia-Romagna, 40010
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Lombardy, 24127
Ospedale Maggiore di Bologna
Bologna, Emilia-Romagna, 40133
A.O.U di Bologna-Policlinico S.Orsola-Malpighi (U.O. Medicina Interna)
Bologna, Emilia-Romagna, 40138
Policlinico Sant'Orsola-Malpighi (U.O. Cardiologia)
Bologna, Emilia-Romagna, 40138
Ospedale di Bolzano (U.O. Cardiologia e Prove Funzionali)
Bolzano, Trentino-Alto Adige, 39100
ASST Spedali Civili P.O di Brescia
Brescia, Lombardy, 25123
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (U.O Medicina Generale 2)
Brescia, Lombardy, 25123
Fondazione Poliambulanza Istituto Ospedaliero - Brescia
Brescia, Lombardy, 25124
Ospedale di Carpi
Carpi, Emilia-Romagna, 41012
Azienda Ospedaliera di Rilievo Nazionale(A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta
Caserta, Campania, 81100
Ospedale Cannizzaro
Catania, Sicily, 95126
Azienda Ospedaliera Universitaria Mater Domini - Site 8042
Catanzaro, Calabria, 88100
Azienda Ospedaliera Universitaria Mater Domini - Site 8053
Catanzaro, Calabria, 88100
Azienda Ospedaliera Universitaria Mater Domini - Site 8059
Catanzaro, Calabria, 88100
Ospedale Civile Santa Maria Incoronata dell'Olmo
Cava de' Tirreni, Campania, 84013
Ospedale Civile SS. Annunziata (MEDICINA INTERNA- DIPARTIMENTO DI MEDICINA E SCIENZE DELL'INVECCHIAMENTO)
Chieti, Abruzzo, 66013
Ospedale San Giuseppe
Empoli, Tuscany, 50053
Arcispedale Sant'Anna Ferrara (U.O. Cardiologia)
Ferrara, Emilia-Romagna, 44124
Azienda Ospedaliera-Universitaria S. Anna di Ferrara (Dipartimento medico)
Ferrara, Emilia-Romagna, 44124
A.O.U. Careggi (S.O.D. Malattie Aterotrombotiche) - Site 8020
Florence, Tuscany, 50134
A.O.U. Careggi - Site 8041
Florence, Tuscany, 50134
A.O.U. Careggi - Site 8093
Florence, Tuscany, 50134
A.O.U. Ospedali Riuniti
Foggia, Apulia, 71122
Presidio Ospedaliero Vito Fazzi
Lecce, Apulia, 73100
Ospedale Mater Salutis
Legnago, Veneto, 37045
Ospedale S. Andrea - Usl Toscana Sud Est
Massa Marittima, Tuscany, 58024
A.O.U. Policlinico "G. Martino" (U.O. Cardiologia)
Messina, Sicily, 98125
IRCCS Multimedica
Milan, Lombardy, 20099
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Centro Cardiologico Monzino - IRCCS (Unità Prevenzione dell'Aterosclerosi)
Milan, Lombardy, 20141
Centro Cardiologico Monzino - IRCCS
Milan, Lombardy, 20141
Istituto Clinico Sant'Ambrogio
Milan, Lombardy, 20149
IRCCS Istituto Ortopedico Galeazzi
Milan, Lombardy, 20161
Grande Ospedale Metropolitano di Niguarda
Milan, Lombardy, 20162
Presidio Ospedaliero di Mirano - ULSS 3 Serenissima
Mirano, Veneto, 30035
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, 41124
Ospedale Civile di Baggiovara- AOU di Modena
Modena, Emilia-Romagna, 41126
Ospedale Regina Montis Regalis
Mondovì, Piedmont, 12084
A.O.R.N. Cardarelli
Naples, Campania, 80131
A.O.R.N. Ospedale dei Colli
Naples, Campania, 80131
A.O.U. FEDERICO II (U.O.C. Diabetologia)
Naples, Campania, 80131
A.O.U. Federico II
Naples, Campania, 80131
Ospedale Buccheri La Ferla
Palermo, Sicily, 90123
Triolo Zancle Hospital
Palermo, Sicily, 90133
USL Umbria I
Perugia, Umbria, 06126
A.O. Santa Maria della Misericordia
Perugia, Umbria, 06129
Ospedale SS Cosma e Damiano di Pescia - Azienda Usl Toscana centro
Pescia, Tuscany, 51017
Ospedale Unico della Valtidone
Piacenza, Emilia-Romagna, 29015
Ospedale Guglielmo da Saliceto
Piacenza, Emilia-Romagna, 29121
Università di Pisa
Pisa, Tuscany, 56100
Fondazione Toscana Gabriele Monasterio
Pisa, Tuscany, 56124
Ospedale Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, 56124
Ospedale di Santo Stefano di Prato - Azienda Usl Toscana centro (UO di Cardiologia)
Prato, Tuscany, 59100
Ospedale Santo Stefano di Prato - Azienda Usl Toscana Centro
Prato, Tuscany, 59100
Ospedale Macerata
Province of Macerata, The Marches, 62100
Ospedale Giovanni Paolo II
Ragusa, Sicily, 97100
Arcispedale Santa Maria Nuova - Azienda USL/IRCCS Reggio Emilia
Reggio Emilia, Emilia-Romagna, 42123
Ospedale dei Castelli - ASL Roma 6
Rome, Lazio, 00040
Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 00128
Policlinico Umberto I
Rome, Lazio, 00161
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Ospedale Policlinico Casilino
Rome, Lazio, 00169
Azienda Ospedaliera San Giovanni Addolorata
Rome, Lazio, 00184
A.O.U. "San Giovanni di Dio e Ruggi d'Aragona"
Salerno, Campania, 84131
Ospedale Civile SS Annunziata (Dipartimento di Medicina Clinica e Sperimentale)
Sassari, Sardinia, 07100
Ospedale Civile San Rocco
Sessa Aurunca, Campania, 81037
Azienda Ospedaliero-Universitaria Senese Dipartimento Delle Scienze Mediche U.O.C. Medicina Interna e della Complessità
Siena, Tuscany, 53100
Ospedale Le Scotte
Siena, Tuscany, 53100
Ospedale degli Infermi di Rivoli
Turin, Piedmont, 10098
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
Presidio Ospedaliero "Santa Maria della Misericordia" di Udine
Udine, Friuli, 33100
Ospedale dei Castelli
Verbania, Piedmont, 28925
Ospedale G. Jazzolino
Vibo Valentia, Calabria, 89900
Spain72 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006
Hospital Principe de Asturias
Alcalá de Henares, Madrid, 28805
Hospital Universitario Fundación Alcorcón
Alcorcón, 28922
H. San Eloy
Barakaldo, Basque Country, 48902
H. Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
H de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
H. del Mar Site 11041
Barcelona, 08003
H. del Mar Site 11065
Barcelona, 08003
H. Univ. Basurto
Bilbao, Basque Country, 48013
H. Univ. de Basurto
Bilbao, Basque Country, 48013
H. Univ. Basurto
Bilbao, 48013
C S Colloto
Colloto, Castille and León, 33010
Centro de Salud Colloto
Colloto, 33010
Hospital de Alta Resolución de Sierra Norte
Constantina, Andalusia, 41450
H. Reina Sofia
Córdoba, Andalusia, 14004
Hospital de Alta Resolución de Ecija
Écija, Andalusia, 41400
Complejo Hospitalario Univ. El Ferrol
Ferrol, Galicia, 15405
H. Universitario Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Univ. Getafe
Getafe, 28905
H Juan Ramón Jiménez de Huelva
Huelva, Andalusia, 21005
H. Infanta Elena
Huelva, Andalusia, 21080
Centro Médico Puerto
Jerez de la Frontera, Andalusia, 11402
HG. Univ. De Jérez
Jerez de la Frontera, Andalusia, 11407
Hospital de Jerez
Jerez de la Frontera, 11407
H. Universitari Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Clinica Privada Orotava
La Orotava, Canary Islands, 38300
Hospital de Alta Resolución de Lebrija
Lebrija, Andalusia, 41570
H Universitario De León
León, Castille and León, 24008
H Clínico de Salamanca
León, Castille and León, 37007
Hospital Universitario de la Princesa Site 11054
Madrid, 28006
Hospital Universitario de la Princesa Site 11062
Madrid, 28006
Hospital Universitario de la Princesa Site 11075
Madrid, 28006
H Gregorio Marañon
Madrid, 28007
Hospital Universitario Gregorio Marañon
Madrid, 28007
Clinica Universitaria de Navarra
Madrid, 28027
Clínica Universitaria de Navarra
Madrid, 28027
Fundación Jiménez Díaz
Madrid, 28029
H. Univ. Clínico San Carlos
Madrid, 28029
H. Univ. La Paz-Carlos III
Madrid, 28029
H. Universitario La Paz-Carlos III
Madrid, 28029
Hospital La Paz-Carlos III
Madrid, 28029
H. Univ. Ramón y Cajal
Madrid, 28034
Fundación Jiménez Díaz
Madrid, 28040
H. Universitario 12 de octubre
Madrid, 28041
H Carlos Haya
Málaga, Andalusia, 29010
H. Costa del Sol
Marbella, Málaga, 29603
H. Clínico Virgen de la Arrixaca
Murcia, 30120
Complejo Hospitalario de Ourense
Ourense, Galicia, 32005
Complejo Hospitalario Universitario de Ourense (CHOU) Site 11003
Ourense, 32005
Complejo Hospitalario Universitario de Ourense (CHOU) Site 11052
Ourense, 32005
H Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
H. San Joan de Reus
Reus, 41009
Hospital Parc Tauli
Sabadell, 08208
C S de la Alamedilla
Salamanca, Castille and León, 37003
Hospital Clínico de Salamanca
Salamanca, 37007
H. Univ. Infanta Sofía
San Sebastián de los Reyes, Madrid, 28709
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28709
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, 8970
Hospital Universitario Marqués de Valdecilla
Santander, 39008
H. Clínico Univ. Santiago de Compostela
Santiago de Compostela, Galicia, 15706
H. General de Segovia
Segovia, Castille and León, 40002
Hospital General de Segovia
Segovia, 40002
H. Univ. Virgen Macarena
Seville, Andalusia, 41009
H. San Agustín
Seville, Andalusia, 41700
Hospital Universitario Virgen de la Macarena
Seville, 41009
Hospital Sant Pau i Santa Tecla
Tarragona, 43003
Hospital HM de Torrelodones
Torrelodones, 28250
H. Alta Resolución de Utrera
Utrera, Andalusia, 41710
Hospital de Alta Resolución de La Janda
Vejer de la Frontera, Andalusia, 11150
Complejo Asistencial de Zamora
Zamora, Castille and León, 49022
Centro de Salud Fuentes Norte
Zaragoza, 50002
United Kingdom51 sites
The Atherstone Surgery
Atherstone, CV9 1EU
Heart of Bath Medical Partnership
Bath, Somerset, BA1 2SR
Ormeau Clinical Trials Ltd
Belfast, Northern Ireland, BT7 2EB
Layton Medical Centre
Blackpool, FY3 7EN
Waterloo Medical Care
Blackpool, FY4 3AD
Glan Clwyd Hospital
Bodelwyddan, Wales, LL18 5UJ
Brockwood Medical Practice
Brockham, Surrey, RH3 7NJ
Llanedeyrn Health Centre
Cardiff, CF23 9PN
Ely Bridge Surgery
Cardiff, CF5 4AD
Carlisle Healthcare
Carlisle, North Cumbria, CA2 7HY
Lakeside Surgery
Corby, Northamptonshire, NN17 2UR
Craigavon Area Hospital
Craigavon, Armagh, BT63 5QQ
Carmel Medical Practice
Darlington, County Durham
Holderness Health Surgery
Hedon
Burbage Surgery
Hinckley, Leicestershire, LE10 2SE
Great Western Hospital Swindon
Huddersfield, Wiltshire, SN3 6BB
Huddersfield Hospital
Huddersfield, Yorkshire, HD3 3EA
Hull Royal Infirmary
Hull, HU3 2JZ
Manor Park Medical Practice
Leicester, East Midlands, LE4 8EA
Oak Tree Surgery
Liskeard, Cornwall, PL14 3XA
Liverpool Heart & Chest Hospital NHS Trust
Liverpool, Merseyside, L14 3PE
Barts Health NHS Trust
London, Greater London, EC1M 6BQ
Church End Medical
London, Greater London, NW10 9HP
Breckland Alliance
London, Norfolk
Newquay Health Centre
Newquay, Cornwall, TR7 1RU
North Tyneside General Hospital
North Shields, Tyne and Wear, NE29 8NH
Danes Camp Medical Centre
Northampton, Northamptonshire, NN4 0NY
Temple Sowerby Medical Practice
Penrith, CA10 1RW
The Alverton Practice
Penzance, Cornwall, TR18 4DX
Wansford and Kings Cliffe Practice
Peterborough, PE8 6PL
Pickering Medical Practice
Pickering, North Yorkshire, YO18 8BL
Knowle House Surgery
Plymouth, Cornwall, PL5 3JB
The Adam Practice
Poole, Dorset
Panthera Preston
Preston, PR1 6YA
The Boathouse Sugery
Reading, Berkshire, RG8 7DP
Clifton Medical Centre
Rotherham, South Yorkshire, S65 1DA
Sherbourne Medical Centre
Royal Leamington Spa, Warwickshire, CV32 4RA
Ecclesfield Group Practice
Sheffield
Princess Royal Hospital
Shrewsbury, Shropshire, SY3 8XQ
Staploe Medical Centre
Soham, Surrey, CB7 5JD
Southend University Hospital
Southend, Essex, SS0 0RY
Branch End Surgery
Stocksfield, Northumberland, NE43 7LL
Sunderland Royal Hospital
Sunderland, Tyne and Wear, SR4 7TP
Huddersfield Hospital
Swindon, West Yorkshire, HD3 3EA
Great Western Hospital Swindon
Swindon, Wiltshire, SN3 6BB
Princess Royal Hospital
Telford, Shropshire, TF1 6TF
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
Whitby Group Practice
Whitby, North Yorkshire, YO21 1SD
Fellview Healthcare
Whitehaven, Cumbria, CA28 7QE
Royal Albert Edward Infirmary
Wigan, WN6 9EP
The Friarsgate Practice
Winchester, Hampshire, SO22 6EL
France36 sites
4 Rue Larrey
Angers, 49900
Cabinet médical Louis Blanc
Anzin, 59410
Clinique d'Argonay
Argonay, 74370
Hôpital Henri Duffaut
Avignon, 84902
Centre de Cardiologie et d'exploration de la Côte Basque
Bayonne, 64100
151 rue Georges Clémenceau
Breteuil, 27160
4 Rue du Capitaine Drillien
Chalon-sur-Saône, 71100
Centre Hospitalier de Chateauroux
Châteauroux, 36000
CH Compiègne
Compiègne, 60200
Centre Hopsitalier Alpes Leman, 552 Route de Findrol
Contamine-sur-Arve, 74130
619 Rue de Saint Vaast
Flesselles, 80260
CHU Grenoble
Grenoble, 38000
2 Boulevard Victor Hugo
Istres, 13800
2 Rue du Dr Schweitzer
La Rochelle, 17000
Hôpital Louis Pasteur
Le Coudray, 28630
222 Avenue du Mont Gaillard
Le Havre, 76620
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Institut Cœur Poumons, Boulevard du Pr Leclercq
Lille, 59000
Centre Hospitalier de Lisieux, 4 Rue Roger Aini
Lisieux, 14100
Centre Hospitalier La Timone
Marseille, 13005
Clinique de Meudon
Meudon-la-Forêt, 92360
Clinique du Pont de Chaume
Montauban, 82000
Clinique du Millénaire
Montpellier, 34000
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Hôpital Guillaume et René Laennec
Nantes, 44093
Centre Hospitalier de Nice
Nice, 06300
CHU Carémeau
Nîmes, 30000
Cabinet médical du docteur Cohen
Paris, 75012
Cabinet de cardiologie
Paris, 75014
Hôpital Pitié Salpétrière
Paris, 75651
Centre Hospitalier de Pau
Pau, 64000
Clinique Sant Hilaire
Rouen, 76000
82 Avenue de Pontaillac
Royan, 17200
Hôpital Sainte Musse
Toulon, 83100
Centre Hospitalier Toulouse
Toulouse, 31059
Hôpital Guy Chatillez
Tourcoing, 59200
Netherlands35 sites
Jeroen Bosch Hospital
's-Hertogenbosch, 5223 GV
Ziekenhuis Groep Twente (ZGT)
Almelo, 7609 PP
ZiekenhuisGroepTwente, Zilvermeeuw 1
Almelo, 7609 PP
Meander Medical Center
Amersfoort, 3813 TZ
Meander Medisch Centrum, Maatweg 3
Amersfoort, 3813 TZ
Bovenij Zekenhuis
Amsterdam, 1030 BD
Albert Schweitzerlaan 31
Apeldoorn, 7334 DZ
Gelre Ziekenhuis
Apeldoorn, 7334 DZ
Tergooi
Blaricum, 1261 AN
Ijsselland Ziekenhuis, Prins Constanijnweg 2
Capelle aan den IJssel, 2906 ZC
IJsselland Ziekenhuis
Capelle aan den IJssel, 2906 ZC
Reinier de Graafweg 5
Delft, 2625 AD
Nico Bolkesteinlaan 75
Deventer, 7416 SE
Van Weel Bethesda
Dirksland, 3247 BW
Slingeland
Doetinchem, 7009 BL
Gelderse Vallei
Ede, 6716 RP
Medisch Spectrum Twente
Enschede, 7512 KZ
Admiraal de Ruijten Ziekenhuis
Goes, 4462 RA
Groene Hart Gouda
Gouda, 2800 BB
Boerhaavelaan 22
Haarlem, 2035 RC
Ropcke Zweers hospital, Jan Weitkamplaan 4-a
Hardenberg, 7772 SE
Saxenburgh Medisch Centrum
Hardenberg, 7772 TS
Ziekenhuis St Jansdal
Harderwijk, 3844 DG
Dr G.H. Amshoffweg 1
Hoogeveen, 7909 AA
Treant Zorggroep
Hoogeveen, 7909 AA
LUMC
Leiden, 2333 ZA
Ikazai Ziekenhuis
Rotterdam, 3083 AN
Els Borst
The Hague, 2545 AA
Rivierenland ziekenhuis Tiel
Tiel, 4002 WP
ETZ
Tilburg, 5022 GC
Nistelrodeseweg 10
Uden, 5406 PT
University Medical Center Utrecht
Utrecht, 3584 CX
Diakonessenhuis Utrecht
Utrecht, 3585 KE
Maxima Medisch Centrum
Veldhoven, 5504 DB
Zaans Medisch Centrum
Zaandam, 1502 DV
Belgium27 sites
ASZ
Aalst, 9300
Imeldaziekenhuis
Bonheiden, 2820
Clinique Saint-Luc
Bouge, 5004
AZ KLINA
Brasschaat, 2930
CHU Saint Pierre
Brussels, 1000
CHU Brugmann
Brussels, 1020
CUB Hospital Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
Cliniques de l'Europe
Brussels, 1180
Private practice
De Haan, 8420
Private practice
De Pinte, 9840
AZ Sint Blasius
Dendermonde, 9200
AZ Sint Lucas
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
Cabinet de médecine générale
Gribomont, 6887
CH Jolimont-Lobbes
Haine-Saint-Paul, 7100
CHR de Huy
Huy, 4500
Jan Yperman Hospital
Ieper, 8900
AZ Groeninge VZW
Kortrijk, 8500
CHC Liège
Liège, 4000
AZ Delta
Roeselare, 8800
AZ Glorieux
Ronse, 9600
Sint Trudo
Sint-Truiden, 3800
Private practice
Tienen, 3300
BVBA Dr CAPIAU
Wetteren, 9230
CHU UCL Namur
Yvoir, 5530
Z Sint Elisabeth Zottegem
Zottegem, 9620
Finland25 sites
Mehiläinen Leppävaara
Espoo, 02600
Geri-Med Oy
Helsinki, 00100
Pihlajalinna Dextra
Helsinki, 00180
Pihlajalinna (Site 04-007)
Joensuu, 80100
Pihlajalinna (Site 04-022)
Joensuu, 80100
StudyCor Oy
Jyväskylä, 40620
Terveystalo Kalajoki
Kalajoki, 85100
Aava Kerava Medical Center
Kerava, 04200
Terveystalo Kokkola
Kokkola, 67100
Mehiläinen Kuopio
Kuopio, 70400
Lappeenrannan Työterveys - Site 4024
Lappeenranta, 53600
Lappeenrannan Työterveys - Site 4025
Lappeenranta, 53600
Terveystalo
Loimaa, 32200
Oulu University Hospital
Oulu, 90220
Satasairaala
Pori, 28500
Sastamalan seudun sosiaali- ja terveyspalvelut
Sastamala, 38200
Seinäjoki Central Hospital
Seinäjoki, 60220
Terveystalo Tampere
Tampere, 33100
Tampere University Hospital
Tampere, 33520
Mehiläinen Turku Kauppiaskatu
Turku, 20100
Turku University Hospital
Turku, 20520
Turku University Hospital
Turku, 20521
Terveystalo Myyrmäki (Site 04015)
Vantaa, 01600
Terveystalo Myyrmäki (Site 04017)
Vantaa, 01600
Finla Työterveys Vantaa
Vantaa, 1380
Austria18 sites
Krankenhaus St. Josef Braunau GmbH
Braunau am Inn, 5280
LKH-Univ. Klinikum Graz
Graz, 8036
Medizinische Universität Graz
Graz, 8036
Medizinische Universität Innsbruck
Innsbruck, 6020
KABEG Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Konventhospital der Barmherzigen Brüder Linz
Linz, 4020
Privatklinik Wehrle-Diakonissen
Salzburg, 5026
Ordination Universitätsdozent Dr. Alexander Kober
Sankt Aegyd am Neuwalde, 3193
Ordination Dr. med. univ. Evelyn Fließer-Görzer
Sankt Stefan, 8511
Ordination Dr. Thomas Maca / Evangelische KH Wien
Vienna, 1010
Ordination Dr. Thomas Maca / Evangelisches KH Wien
Vienna, 1010
Krankenhaus Rudolfstiftung
Vienna, 1030
Zentrum für Klinische Studien Dr. Hanusch GmbH
Vienna, 1060
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090
Ordination Dr. Reinhard Sock
Vienna, 1100
Krankenhaus Hietzing mit neurologischem Zentrum Rosenhügel
Vienna, 1130
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
Internistische Facharztpraxis Frau Dr. Carmen Gelsinger
Zams, 6511
Denmark12 sites
Hjerteklinik Osterbro
Copenhagen, 2100
Amager Hospital
Copenhagen, 2300
Bispebjerg-Frederiksberg Hospital
Copenhagen, 2400
Bispebjerg/ Frederiksberg Hospital
Copenhagen, 4200
Sydvestjysk Sygehus Esbjerg
Esbjerg, 6700
Frederiksberg Hjerteklinik
Frederiksberg, 2000
Frederiksberg Hjerteklinik
Frederiksberg, 8009
Stroke center Rigshospitalet
Glostrup Municipality, 232600
Rigshospitalet (Copenhagen University Hospital) - Glostrup (Glostrup Hospital)
Glostrup Municipality, 2600
Gentofte Hospital
Hellerup, 2900
Kobenhavns Universitet - Holbaek Sygehus
Holbæk, 4300
Slagelse sygehus
Slagelse, 4200
Portugal11 sites
Instituto do Coração
Carnaxide, 2794-006
Centro Hospitalar Universitario do Algarve
Faro, 8000-386
Associação Protetora de Diabéticos de Portugal
Lisbon, 1250-189
Hospital Egas Moniz (CHLO)
Lisbon, 1349-019
Hospital Lusíadas de Lisboa, Lisboa
Lisbon, 1500-458
Centro Hospitalar Lisboa Norte - Site 10005
Lisbon, 1649-028
Centro Hospitalar Lisboa Norte - Site 10006
Lisbon, 1649-028
Clínica Cuida Mais
Mangualde, 3530-191
Centro Hospitalar Universitário São João (CHUSJ)
Porto, 4200-319
Instituto CUF Porto
Porto, 4460-188
Centro Hospitalar de Entre Douro e Vouga
Santa Maria da Feira, 4520-179
Sweden11 sites
Falu Lasarett, Diab/Endo-mottagning
Falun, 79182
Sahlgrenska University Hospital
Gothenburg, 41345
Östra Sahlgrenska Universitetssjukhuset - Ostra Sjukhuse
Gothenburg, 41685
Värmdö Vårdcentral
Gustavsberg, 13444
Öbackakliniken
Härnösand, 87131
Länssjukhuset Ryhov
Jönköping, 55305
Capio Citykliniken
Lund, 22221
Skåne University Hospital
Malmö, 20502
Cityheart
Stockholm, 11157
Södersjukhuset Stockholm
Stockholm, 11883
Karolinska University Hospital, Huddinge
Stockholm, 14186
Switzerland11 sites
Kantonsspital Baden AG
Baden, 5404
Universitätsspital Basel
Basel, 4031
Hôpitaux Universitaires de Genève
Geneva, 1205
University of Lausanne Unisanté
Lausanne, 1010
Cardio Center Luzern
Lucerne, 6003
Kardiolab
Olten, 4600
Solothurner Spitäler AG
Olten, 4600
Kantonsspital St. Gallen
Sankt Gallen, 9007
Cardiologue FMH
Yverdon-les-Bains, 1400
Klinik Hirslanden
Zurich, 8032
Universitätsspital Zürich
Zurich, 8091
Ireland7 sites
Beaumont Hospital
Beaumont, Dublin
Cork University Hospital
Cork, T23
Mater Private Hospital
Dublin, D07 WKW8
St. James Hospital
Dublin, D08 NHY1
Beacon Hospital
Dublin, D18 AK68
Turloughmore Health Centre
Galway
Tramore Medical Clinic
Tramore, Waterford
About this study
Official title: Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal Study (SANTORINI)
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.
Read the detailed description
Suffering from hypercholesterolemia is a major health concern in Europe. Appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. Despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. As this is a non-interventional study, only data from routine clinical practice will be documented.
- Conditions
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Being tested
- Non-interventional
- Keywords
- High-risk dyslipidemic, Low-density lipoprotein cholesterol, Cardiovascular disease, Lipid modifying therapies, Dyslipidemia, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Medical subject headings
- Dyslipidemias, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Participants are classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
Blood plasma samples were used to assess LDL-C levels.
Measured: Baseline up to 12 months post-enrollment
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Clinical events were assessed based on information captured in patient files/medical records.
Measured: Baseline up to 12 months post-enrollment
Secondary outcomes (5)
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels.
Measured: Baseline up to 12 months post-enrollment
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess Apolipoprotein B levels.
Measured: Baseline up to 12 months post-enrollment
Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess lipid Protein A levels.
Measured: Baseline up to 12 months post-enrollment
Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess hsCRP levels.
Measured: Baseline up to 12 months post-enrollment
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
The safety outcome measure reports clinical events based on information captured in patient files/medical records. Participants may have reported more than one clinical event associated with any LMT.
Measured: Baseline up to 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start17 Mar 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 9,559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact for Clinical Trial Information, Study director, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271280
- Sponsor's protocol ID
- DSE-HCL-01-19-EU
- Acronym
- SANTORINI
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2020
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toplak H, Komen JJ, Bardet A, Catapano AL, Ray KK; SANTORINI Investigators. Low-density lipoprotein cholesterol management and goal attainment at 1 year in patients with diabetes, pre-diabetes and normoglycaemia: results from the European, prospective, observational SANTORINI study. BMJ Open. 2026 Jun 29;16(6):e108737. doi: 10.1136/bmjopen-2025-108737.
PubMed 42373176Ray KK, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Boachie C, Lee B, Soronen J, Becker C, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI study investigators. Potential impact on cholesterol goal achievement and predicted cardiovascular risk by the addition of ezetimibe and bempedoic acid on top of statins: a simulation from the SANTORINI study. Am J Prev Cardiol. 2026 Mar 24;27:101577. doi: 10.1016/j.ajpc.2026.101577. eCollection 2026 Jun.
PubMed 42291044Connolly D, Fuat A, McCormack T, Mcnally D, Garstang J, Ryan J, Reed A, Robinson D, Catapano AL, Ray KK. Real-world changes in lipid-lowering therapy use and LDL-C goal attainment in high and very high cardiovascular risk patients in the UK: a secondary analysis of the European SANTORINI study 1-year follow-up. BMJ Open. 2026 Apr 24;16(4):e114031. doi: 10.1136/bmjopen-2025-114031.
PubMed 42031497Aguiar C, Aguiar P, Sequeira Duarte J, Gil V, Mimoso J, Monteiro P, Pinto FJ, Pinto F, Raposo J, von Hafe P, Ruivo JA, Teixeira C, Catapano AL, Ray KK. Lipid-lowering therapy and LDL cholesterol control among high- and very high-risk patients in Portugal: An analysis of the SANTORINI study. Rev Port Cardiol. 2026 Feb;45(2):51-64. doi: 10.1016/j.repc.2025.10.003. Epub 2025 Nov 28. English, Portuguese.
PubMed 41319792Arca M, Calabro P, Solini A, Pirillo A, Gambacurta R, Ray KK, Catapano AL; SANTORINI Italian Group. Challenges in achieving LDL-C goals: Insights from the Italian SANTORINI study cohort. Nutr Metab Cardiovasc Dis. 2026 Feb;36(2):104412. doi: 10.1016/j.numecd.2025.104412. Epub 2025 Oct 14.
PubMed 41125511Mostaza JM, Garcia-Ortiz L, Suarez Tembra MA, Talavera Calle P, Chimeno Garcia J, Escolar Perez V, Diaz-Diaz JL, Manzano-Espinosa L, Catapano AL, Ray KK, Diaz Moya G, Pedro-Botet Montoya J; en representacion del grupo de investigadores de SANTORINI Espana. Failure of LDL-C goals achievement and underuse of lipid-lowering therapies in patients at high and very high cardiovascular risk: Spanish subset from the European SANTORINI study. Rev Clin Esp (Barc). 2025 Feb;225(2):78-84. doi: 10.1016/j.rceng.2024.11.004. Epub 2024 Nov 28.
PubMed 39613100Ray KK, Haq I, Bilitou A, Manu MC, Burden A, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI Study Investigators. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. Lancet Reg Health Eur. 2023 Apr 5;29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun.
PubMed 37090089
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal Study (SANTORINI)
- ClinicalTrials.gov ID
- NCT04271280
- Acronym / sponsor ID
- SANTORINI / DSE-HCL-01-19-EU
- Conditions
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Keywords
- High-risk dyslipidemic, Low-density lipoprotein cholesterol, Cardiovascular disease, Lipid modifying therapies, Dyslipidemia, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,559 participants (actual)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.
Detailed description
Suffering from hypercholesterolemia is a major health concern in Europe. Appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. Despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. As this is a non-interventional study, only data from routine clinical practice will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | – | Other: Non-interventionalParticipants are classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High risk and very high-risk participants requiring lipid-modifying therapies
Key inclusion criteria (4 listed)
- Very High Risk and High Risk dyslipidemic patients requiring LMTs
- Not simultaneously participating in any interventional study
- Providing written informed consent for participation in the study (Informed consent form)
- Life expectancy > 1 year
Key exclusion criteria (1 listed)
- Not applicable; non-interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalThis is a non-interventional study. | Other | High Risk and Very High Risk Dyslipidemic Participants |
Primary outcome
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
Time frame: Baseline up to 12 months post-enrollment
Blood plasma samples were used to assess LDL-C levels.
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Time frame: Baseline up to 12 months post-enrollment
Clinical events were assessed based on information captured in patient files/medical records.
5 secondary outcomes
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Time frame: Baseline up to 12 months post-enrollment
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants
Time frame: Baseline up to 12 months post-enrollment
Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants
Time frame: Baseline up to 12 months post-enrollment
Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants
Time frame: Baseline up to 12 months post-enrollment
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
Time frame: Baseline up to 12 months post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42373176Toplak H, Komen JJ, Bardet A, Catapano AL, Ray KK; SANTORINI Investigators. Low-density lipoprotein cholesterol management and goal attainment at 1 year in patients with diabetes, pre-diabetes and normoglycaemia: results from the European, prospective, observational SANTORINI study. BMJ Open. 2026 Jun 29;16(6):e108737. doi: 10.1136/bmjopen-2025-108737.
- Derived from this study: PubMed 42291044Ray KK, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Boachie C, Lee B, Soronen J, Becker C, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI study investigators. Potential impact on cholesterol goal achievement and predicted cardiovascular risk by the addition of ezetimibe and bempedoic acid on top of statins: a simulation from the SANTORINI study. Am J Prev Cardiol. 2026 Mar 24;27:101577. doi: 10.1016/j.ajpc.2026.101577. eCollection 2026 Jun.
- Derived from this study: PubMed 42031497Connolly D, Fuat A, McCormack T, Mcnally D, Garstang J, Ryan J, Reed A, Robinson D, Catapano AL, Ray KK. Real-world changes in lipid-lowering therapy use and LDL-C goal attainment in high and very high cardiovascular risk patients in the UK: a secondary analysis of the European SANTORINI study 1-year follow-up. BMJ Open. 2026 Apr 24;16(4):e114031. doi: 10.1136/bmjopen-2025-114031.
- Derived from this study: PubMed 41319792Aguiar C, Aguiar P, Sequeira Duarte J, Gil V, Mimoso J, Monteiro P, Pinto FJ, Pinto F, Raposo J, von Hafe P, Ruivo JA, Teixeira C, Catapano AL, Ray KK. Lipid-lowering therapy and LDL cholesterol control among high- and very high-risk patients in Portugal: An analysis of the SANTORINI study. Rev Port Cardiol. 2026 Feb;45(2):51-64. doi: 10.1016/j.repc.2025.10.003. Epub 2025 Nov 28. English, Portuguese.
- Derived from this study: PubMed 41125511Arca M, Calabro P, Solini A, Pirillo A, Gambacurta R, Ray KK, Catapano AL; SANTORINI Italian Group. Challenges in achieving LDL-C goals: Insights from the Italian SANTORINI study cohort. Nutr Metab Cardiovasc Dis. 2026 Feb;36(2):104412. doi: 10.1016/j.numecd.2025.104412. Epub 2025 Oct 14.
- Derived from this study: PubMed 39613100Mostaza JM, Garcia-Ortiz L, Suarez Tembra MA, Talavera Calle P, Chimeno Garcia J, Escolar Perez V, Diaz-Diaz JL, Manzano-Espinosa L, Catapano AL, Ray KK, Diaz Moya G, Pedro-Botet Montoya J; en representacion del grupo de investigadores de SANTORINI Espana. Failure of LDL-C goals achievement and underuse of lipid-lowering therapies in patients at high and very high cardiovascular risk: Spanish subset from the European SANTORINI study. Rev Clin Esp (Barc). 2025 Feb;225(2):78-84. doi: 10.1016/j.rceng.2024.11.004. Epub 2024 Nov 28.
- Derived from this study: PubMed 37090089Ray KK, Haq I, Bilitou A, Manu MC, Burden A, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI Study Investigators. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. Lancet Reg Health Eur. 2023 Apr 5;29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Contact for Clinical Trial Information study director
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
540 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia and Cardiovascular Diseases, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 540 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 540 sites in Germany, Italy, Spain, United Kingdom, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants (time frame: Baseline up to 12 months post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04271280, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.