1,426
Participants
Start Date
March 21, 2017
Primary Completion Date
February 28, 2021
Study Completion Date
February 28, 2021
Edoxaban-based Regimen
15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
VKA-based Regimen
Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
Wilhelminenspital, Vienna
Universitätsklinik für Innere Medizin II, Vienna
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Vienna
Hopitaux Universitaires de Geneve, Geneva
ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen, Antwerp
UZA - Universtiair Ziekenhuis Antwerpen, Edegem
Bern University Hospital, Bern
Jessa Ziekenhuis- Campus Virga Jessa, Hasselt
ZOL Genk, Campus Sint-Jan, Genk
Universitatsspital Basel, Basel
Herzzentrum Leipzig, Leipzig
Clinic Wels-Grieskirchen GmbH, Grieskirchen
Universitaetsklinik fuer Innere Medizin III, Innsbruck
Cardiocentro Ticino, Lugano
Medizinische Universitaet Graz, Graz
AZ Delta Roeselare, Roeselare
Klinikum Klagenfurt am Worthersee, Klagenfurt
ASZ Aalst - Aalst campus, Aalst
Mt. Sinai Hospital, New York
Northshore Community Hospital, Manhasset
NY Presbyterian - Brooklyn Methodist Hospital, Brooklyn
St. Francis Hospital, East Hills
Ospedale S. Croce e Carle, Cuneo
Charite Universitatsmedizin Berlin, Berlin
St. Joseph's Physicians, East Syracuse
Rochester General Hospital, Geneva
Complexo Hospitalario Universitario de A Coruna, A Coruña
Complexo hospitalario universitario de Santiago de Compostela, A Coruña
Immanuel Klinikum Bernau Herzzentrum Brandenburg, Berlin
Penn State Health, Milton S. Hershey Medical Center, Hershey
Pinnacle Health, Wormleysburg
WellSpan York Hospital, York
Complejo Asistencial de Granada, Granada
St. Luke's University Health Network, Bethlehem
Geisinger Wyoming Valley Medical Center, Wilkes-Barre
Doylestown Health Cardiothoracic Surgery, Doylestown
Medstar Washington Hospital Center, Washington D.C.
Hospital Universitario Donostia, Donostia / San Sebastian
ASST Ovest Milanese - Presidio Ospedallero di Legnana, Legnano
Medical Facility Associates, Washington D.C.
Istituto Clinico Humanitas, Rozzano
Asklepios St. Georg Abteilung fuer Kardiologie, Hamburg
Ospedale San Raffaele, Milan
Centro Cardiologico Monzino IRCCS, Milan
ASST Grande Ospedale Metropolitano Niguarda, Milan
Washington Adventist Hospital, Takoma Park
Inova Heart and Vascular Institute, Falls Church
Segeberger Kliniken, Bad Segeberg
Azienda Socio Sanitaria Territoriale di Lecco, Lecco
Universitaetsklinik Schleswig-Holstein Campus Kiel, Kiel
ASST Spedali Civili di Brescia-UO Cardiologia, Brescia
CAMC Memorial Hospital, Charleston
Klinikum Oldenburg AöR, Oldenburg
Fondazione IRCCS Policlinico San Matteo, Pavia
IRCCS Policlinico San Matteo, Pavia
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health, Greensboro
East Carolina Heart Institute, Greenville
Hospital La Luz QuironSalud, Madrid
Hospital Universitario La Princesa, Madrid
Hospital Universitario Ramón y Cajal, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Universitario La Paz, Madrid
Gesundheit Nord gGmbH, Bremen
Hospital Universitario Virgen de la Victoria, Málaga
Hospital Virgen de la Arrixaca, Murcia
Clinique Pasteur / GCVI, Toulouse
Cardiology Associate Research, Daytona Beach
UF Health Jacksonville, Jacksonville
Tallahassee Research Institute, Inc., Tallahassee
Hospital Universitario Central de Asturias, Oviedo
Memorial Healthcare Systems, Hollywood
Clinique Saint Augustin, Bordeaux
International Research Partners, LLC., Doral
CHU de Bordeaux Hopital du Haut Leveque, Pessac
Watson Clinic Center for Research, Lakeland
CHU Arnaud de Villeneuve, Montpellier
Clinique du Millenaire Service de Cardiologie Interventionelle, Montpellier
Azienda Ospedaliera di Padova, Padua
University of Alabama at Birmingham, Birmingham
Klinikum Fulda gAG, Fulda
Hospital Universitario Alvaro Cunqueiro, Vigo
Azienda Ospedaliera Integrata di Verona, Verona
SCRI - Centennial Medical Center, Nashville
Valdecilla Hospital, Santander
Jackson Heart Clinic, Jackson
Policlinico Sant'Orsola-Malpighi, Bologna
Universitätsklinikum Düsseldorf, Düsseldorf
Hospital Universitario Virgen Macarena, Seville
Hospital Universitario Virgen del Rocio, Seville
Helios Herzzentrum Wuppertal, Wuppertal
IRCCS-ASMN Reggio Emilia, Reggio Emilia
Promedica Toledo Hospital, Toledo
Klinikum der Stadt Ludwigshafen, Dortmund
St. Johannes - Hospital, Dortmund
Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie, Essen
Hospital Clinico de Valencia, Valencia
Hospital Clinico Universitario de Valladolid, Valladolid
Michigan Heart, St. Joseph Mercy Health System, Ypsilanti
MidMichigan Medical Center Midland, Midland
Sparrow Clinical Research Institute, Lansing
University of Iowa Hospitals and Clinics, Iowa City
UOC Emodinamica III, Siena
Aurora St. Luke's Medical Center, Milwaukee
Fondazione Toscana Gabriele Monasterio, Massa
Krankenhaus der Barmherzigen, Trier
HealthEast Medical Research Institute, Saint Paul
Universitatsmedizin Mainz, Zentrum fur Kardiologie, Mainz
Essentia Health, Duluth
Mayo Clinic Rochester, Rochester
Azienda Ospedaliero-Universitaria Pisana, Pisa
Black Hills Cardiovascular Research, Rapid City
Institut Coeur Poumon - CHRU de Lille, Lille
Ospedali Riuniti Torrette Di Ancona, Ancona
Rush University Medical Center, Chicago
Kerckhoff-Klinik, Bad Nauheim
Carle Foundation Hospital, Urbana
Clinical Investigators LLC, St Louis
Nouvel Hopital Civil, Strasbourg
Heidelberg University Hospital, Heidelberg
Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III, Tübingen
Arkansas Site Management Services, Little Rock
Citta di Lecce Hospital, Lecce
Oklahoma Heart Hospital Research Foundation, Oklahoma City
Institut Mutualiste Montsouris, Paris
Legacy Heart Center, Plano
Hopital Bichat, Paris
CHU de Rouen, Rouen
Clinique Saint-Hilaire, Rouen
St. Vincent Heart Center, Indianapolis
Houston Methodist Research Institute, Houston
University of Texas Health Science Center Houston, Houston
MediClin Herzzentrum Lahr/Baden, Lahr
Seton Heart Institute, Austin
Clinica Mediterranea, Napoli
A.A Dei Colli Monaldi UOC Cardiologia Interventistica, Napoli
Deutsches Herzzentrum Munchen, München
Universitatsklinikum Essen, Klinik fur Kardiologie, München
Klinikum rechts der Isar der Technischen Universitat Munchen, München
AOU S.Giovanni Di Dio e Ruggi D'Aragona, Salerno
University of Arizona Sarver Heart Center, Tucson
New Mexico Heart Institute, Albuquerque
Magna Graecia University, Catanzaro
Universitatsklinikum Ulm, Ulm
Renown Regional Medical Center, Reno
Cedar-Sinai Heart Institute, Los Angeles
UCLA Cardiovascular Center, Los Angeles
Loma Linda University Medical Center, Loma Linda
Uniklinikum Regensburg, Med II, Regensburg
Hopital Henri Mondor, Créteil
University of California - San Francisco, San Francisco
Centro Cuore Morgagni, Pedara
AOU Policlinico Vittorio Emanuele, Catania
Universitatsklinikum Wurzburg, Würzburg
Providence Heart and Vascular Institute, Portland
Southern Oregon Cardiology, Medford
Herz und Gefaess Klinik, Bad Neustadt an der Saale
Virginia Mason Medical Center, Seattle
Providence Sacred Heart Medical Research Center, Spokane
Santa Barbara Cottage Hospital, Santa Barbara
Maine Medical Center, Scarborough
Baystate Health, Springfield
University of Massachusetts Memorial Medical Center, Worcester
Hackensack University Medical Center, Hackensack
The Valley Hospital, Paramus
Stony Brook University Medical Center, Stony Brook
Hospital Erasme, Brussels
CHU de Liege, Liège
University of Alberta Hospital, Edmonton
Kingston Health Sciences Centre, Kingston
London Health Sciences Centre, London
Newmarket Cardiac Surgery Research Incorporated, Newmarket
Sunnybrook Health Sciences Centre, Toronto
University Health Network, Toronto
Montreal Heart Institute, Montreal
Hamilton General Hospital, Hamilton
Universitè Laval, Québec
Horizon Health Network, Saint John
CHU d'Angers, Angers
IRCCS Policlinico San Donato, San Donato Milanese
Seoul National University Hospital, Seoul
Yonsei University Severance Hospital, Seoul
Asan Medical Center, Seoul
Heart Center Dresden, University Clinic Technical University Dresden, Dresden
Universitatsklinikum Halle (Saale), Halle
AO San Camillo Forlanini, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome
AOU Careggi, Interventistica Cardiologica Strutturale, Rome
Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica, Rome
Nagoya Heart Center, Toyohashi
Toyohashi Heart Center, Aichi
Kokura Memorial Hospital, Kitakyushu
Ogaki Municipal Hospital, Ōgaki
Sapporo Higashi Tokushukai Hospital, Sapporo
Tsukuba Medical Center Hospital, Amakubo
Teikyo University Hospital, Tokyo
Iwate Medical University Hospital, Morioka
Tokai University Hospital, Isehara
St. Marianna University School of Medicine Hospital, Kawasaki
Saiseikai Yokohamashi Tobu Hospital, Yokohama
Sendai Kousei Hospital, Sendai
Osaka City University Hospital, Abeno Ward
Kishiwada Tokushukai Hospital, Kishiwada
Keio University Hospital, Shinjuku
New Tokyo Hospital, Chiba
Shonan Kamakura General Hospital, Kanagawa
Toyama University Hospital, Toyama
Academic Medical Center, Amsterdam
University Medical Center Groningen, Groningen
Medisch Centrum Leeuwarden, Leeuwarden
Erasmus Medical Center, Rotterdam
HagaZiekenhuis, The Hague
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok
University Clinical Centre in Gdańsk, Gdansk
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan
Seoul St. Mary's Hospital, Seoul
Korean University Anam Hospital, Seoul
Hospital Universitari Germans Trias I Pujol, Badalona
Hospital General Universitario de Alicante, Alicante
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clinico y Provincial de Barcelona, Barcelona
BSUH, Cardiac Research Unit, Brighton
Papworth Hospital NHS Foundation Trust, Cambridge
Royal Edinburgh Infirmary, Edinburgh
Guys St Thomas Hospital, London
Trent Cardiac Centre, Nottingham
Oxford University Hospitals, John Radcliffe Hospital, Oxford
Northern General Hospital, Sheffield
University Hospital of Wales, Heath Park, Cardiff
University Hospitals of Leicester NHS Trust, Leicester
Derriford Hospital, Plymouth
Lead Sponsor
Collaborators (1)
Chiltern International Inc.
INDUSTRY
Daiichi Sankyo
INDUSTRY