Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

PHASE3CompletedINTERVENTIONAL
Enrollment

632

Participants

Timeline

Start Date

March 21, 2017

Primary Completion Date

September 24, 2018

Study Completion Date

September 24, 2018

Conditions
Atrial Fibrillation
Interventions
DRUG

Edoxaban

Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects.

DRUG

VKA-Based Regimen

Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea.

DRUG

VKA-Based Regimen

Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.

DRUG

VKA-Based Regimen

Dosed at INR levels. Standard of Care treatment in France.

DRUG

VKA-Based Regimen

Dosed at INR levels. Standard of Care treatment in Spain.

Trial Locations (75)

112

Taipei Veterans General Hospital, Taipei

1070

Erasme Hospital, Brussels

1090

UZ Brussel, Brussels

1122

Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika, Budapest

1134

Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály, Budapest

2020

ZNA Middelheim, Antwerp

2650

Universitair Ziekenhuis Antwerpen, Edegem

4032

Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika, Debrecen

6725

Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ, Szeged

8036

Hospital Clinic Cardiologia, Barcelona

8900

Zala Megyei Szent Rafael Kórház Kardiológia Osztály, Zalaegerszeg

13353

Charité Universitätsmedizin Berlin - CVK Medizinische Klinik m.S. Kardiologie, Berlin

14021

IKEM, Prague

18057

Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie, Rostock

20251

Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie, Hamburg

27100

Istituto di Cura cittè di Pavia, Pavia

28040

Fundacion Jimenez Diaz, Madrid

29124

"Azienda Ospedaliera di Piacenza Ospedale Guglielmo d Saliceto", Piacenza

30174

Ospedale dell'Angelo, Mestre

33305

Chang Gung Memorial Hospital, Taoyuan

33604

Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin, Bielefeld

37024

Ospedale Santo Cuore, Negrar

40113

Masarykova nemocnice - Kardiologie Krajská zdravotní, a.s., Ústí nad Labem

40225

University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology, Düsseldorf

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital (VGH-TC), Taichung

44124

Arcispedale Sant'Anna, Cona

44137

Klinik für Innere Medizin I, Dortmund

48149

Univ. of Muenster.Cardiovascular Medicine, Münster

50122

Azienda USL Toscana, Florence

52100

Ospedale San Donato, Arezzo

58100

Ospedale della Misericordia, Grosseto

69120

University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology, Heidelberg

69691

St. Anne's University Hospital Brno, International Clinical Research Center, Brno

70021

"Ospedale Ecclesiastico Miulli", Sant'Eramo

72076

Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie, Tübingen

79189

Universitäts Herzzentrum Freiburg-Bad Krozingen Klinik für Kardiologie und Angiologie II, Bad Krozingen

80082

ASST Vimercate, Monza

81030

Pineta Grande Hospital, Castel Volturno

83301

Chang Gung Memorial Hospital, Kaohsiung City

88100

Universita' degli Studi Catanzaro, Catanzaro

89081

Universitätsklinikum Ulm, Ulm

96450

Klinikum Coburg GmbH II.Med.Klinik, Coburg

97080

Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I, Würzburg

T2N 4Z6

University of Calgary, Calgary

L8L 2X2

Hamilton Health Sciences/McMaster University, Hamilton

H1T 1C8

Montreal Heart Institute, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

625 00

FN Brno, Brno

100 34

FN Kralovske Vinohrady, Prague

128 08

VFN v Praze II. Interní klinika - Kardiologie a angiologie, Prague

150 06

University Hospital Motol - Cardiology, Prague

04289

Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie, Leipzig

H 7624

Pecs University Clinical Center, Pécs

00169

Policlinico Casilino, Roma

00168

Largo Agostino Gemelli, Rome

31-501

University Hospital - Szpital Uniwersytecki, Krakow

92-213

Klinika Intensywnej Terapii Kardiologicznej, Lodz

20-954

Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii, Lublin

04-073

Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ, Warsaw

41-800

Oddział Kliniczny Kardiologii SUM Katedra Kardiologii, Zabrze

06351

Samsung Medical Center, Seoul

03080

Seoul National University Hospital, Seoul

03722

Yonsei University Severance Hospital, Seoul

02841

Korea University Anam Hospital, Seoul

138-736

Asan Medical Center, Seoul

03540

Hospital General Universitario, Alicante

08003

Hospital del Mar, Barcelona

03550

Hospital Universitario San Juan de Alicante, Sant Joan d'Alacant

FY3 8NR

Blackpool Teaching Hospitals NHS, Blackpool

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

CB23 3RE

Papworth Hospital NHS Trust, Cambridge

LS1 3EX

Leeds General Infirmary, Leeds

SE5 9RS

King's College Hospital, London

NG5 1PB

Nottingham City Hospital, Nottingham

All Listed Sponsors
lead

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

NCT02942576 - Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation | Biotech Hunter | Biotech Hunter