Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

NACompletedINTERVENTIONAL
Enrollment

607

Participants

Timeline

Start Date

January 24, 2017

Primary Completion Date

October 9, 2018

Study Completion Date

October 9, 2018

Conditions
Atrial Fibrillation
Interventions
DRUG

Edoxaban

Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.

Trial Locations (233)

1001

MEDIVASA s r o, Žilina

1020

C H U Brugmann - Site Victor Horta, Brussels

1021

Budapesti Szent Ferenc Korhaz, Budapest

1023

Budai Irgalmasrendi Korhaz, Budapest

1032

Szent Margit Korhaz, Budapest

1036

Obudai Egeszsegugyi Centrum Kft, Budapest

1106

Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1122

Semmelweis Egyetem, Budapest

1125

Semmelweis Egyetem, Budapest

1135

Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet, Budapest

1145

Uzsoki Utcai Korhaz, Budapest

1202

Second MHAT - Sofia AD, Sofia

1233

Fifth MHAT - Sofia EAD, Sofia

NMTH Tsar Boris III, Sofia

1309

MHAT - National Heart Hospital EAD, Sofia

1431

UMHAT Alexandrovska EAD, Sofia

1527

UMHAT 'Tsaritsa Yoanna - ISUL' EAD, Sofia

1606

Fourth MHAT - Sofia EAD, Sofia

1701

Kardiologicka ambulancia Dr Kolikova, Považská Bystrica

1750

UMHAT 'Sveta Anna' AD, Sofia

2091

Kyiv City Clinical Hospital 1, Kyiv

Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC, Kyiv

2100

Rigshospitalet, København Ø

2260

ZNA Middelheim, Antwerp

2300

AZ Turnhout - Campus Sint-Elisabeth, Turnhout

Amager Hospital, Copenhagen S

2400

Bispebjeg og Fredeiksberg Hospital, Copenhagen

2650

Hvidovre Hospital, Hvidovre

2660

SI Heart Institute of the MoH of Ukraine, Kyiv

2730

Herlev Hospital, Herlev

2800

AZ Sint-Maarten, Mechelen

2900

Gentofte Hospital, Hellerup

2921

Selye Janos Korhaz, Komárom

3000

Universitairsitaire Ziekenhuizen Leuven, Leuven

3300

Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger

3500

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

3550

St-Franciskus Ziekenhuis, Heusden-Zolder

3680

SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102), Kyiv

SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116), Kyiv

4000

C H R de la Citadelle, Liège

UMHAT Sv Georgi EAD, Plovdiv

4001

Medicalgroup s r o, Košice

4002

MHAT-Plovdiv AD, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont (4002), Debrecen

Debreceni Egyetem Klinikai Kozpont (4025), Debrecen

4101

Grof Tisza Istvan Korhaz, Berettyóújfalu

4120

Hospital Virgen del Mar, Almería

4200

Slagelse Sygehus, Slagelse

4300

Holbæk Sygehus, Holbæk

4400

MHAT - Pazardzhik AD, Pazardzhik

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4800

Nykøbing F Sygehus, Nykøbing Falster

5300

MHAT Dr Tota Venkova AD, Gabrovo

5600

Belgyogyaszati es Kardiologiai Maganrendelo, Békéscsaba

5800

MHAT Sv Pantaleymon - Pleven OOD, Pleven

SHATC Pleven EAD, Pleven

UMHAT 'Dr Georgi Stranski' EAD, Pleven

6000

Bacs-Kiskun Megyei Korhaz, Kecskemét

6300

Medical Center Haskovo EOOD, Haskovo

MHAT-Haskovo AD, Haskovo

Studium Egeszseghaz Kft, Kalocsa

6400

MHAT 'Sveta Ekaterina' EOOD, Dimitrovgrad

6500

Principal SMO Kft, Baja

6600

Csongrad Megyei Dr Bugyi Istvan Korhaz, Szentes

6725

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

6800

Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako, Hódmezővásárhely

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

7624

Pecsi Tudomanyegyetem, Pécs

8000

AZ Sint-Jan Brugge, Bruges

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8001

Medispol s r o, Prešov

8003

Hospital del Mar, Barcelona

8023

Hospital Quiron Barcelona, Barcelona

8200

Jeruzsalemhegyi Egeszseghaz, Veszprém

8501

Alian s r o, Bardejov

8800

Regionshospitalet Viborg, Viborg

Kanizsai Dorottya Korhaz, Nagykanizsa

8830

Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat

8900

Zala Megyei Szent Rafael Korhaz, Zalaegerszeg

8901

Interna SK s r o, Svidník

9000

SHATC Cardiolife OOD, Varna

9024

Petz Aladar Megyei Oktato Korhaz, Győr

9300

O L V Ziekenhuis, Aalst

10000

Clinical Hospital Center Sestre Milosrdnice, Zagreb

Clinical Hospital Dubrava, Zagreb

Clinical Hospital Sveti Duh, Zagreb

University Hospital center Zagreb (2108), Zagreb

University Hospital center Zagreb (2110), Zagreb

10003

O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC, Zhytomyr

10004

CI Central City Hospital 2 of Zhytomyr, Zhytomyr

11000

Clinical Center of Serbia, Belgrade

Military Medical Academy, Belgrade

Clinical Center Kragujevac, Kragujevac

11040

Clinical Center Dr Dragisa Misovic Dedinje, Belgrade

Dedinje Cardiovascular Institute, Belgrade

11080

Clinical Center Bezanijska kosa, Belgrade

13419

Dr Arvo Rosenthal LLC, Tallinn

North Estonia Medical Centre Foundation, Tallinn

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

18000

Clinical Center Nis, Niš

18009

Cherkasy Regional Cardiological Center, Cherkasy

CI Cherkasy RH of Cherkasy Regional Council, Cherkasy

18205

Niska Banja, Niška Banja

20000

General Hospital Dubrovnik, Dubrovnik

21018

M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1, Vinnytsia

21204

Institute of Cardiovascular Diseases of Vojvodina, Kamenitz

23000

General Hospital Zadar, Zadar

28007

Hospital General Universitario Gregorio Marañon, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

34000

Clinical Center Kragujevac, Kragujevac

35000

General Hospital Dr Josip Bencevic, Slavonski Brod

36038

First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy, Poltava

41009

Hospital Universitario Virgen Macarena, Seville

42000

General Hospital Varazdin, Varaždin

43024

CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis, Lutsk

45600

Hospital Nuestra Señora del Prado, Talavera de la Reina

47144

Kaunas Clinical Hospital Public Institution, Kaunas

48000

General Hospital Dr Tomislav Bardek, Koprivnica

49217

Special Hospital for medical rehabilitation, Krapinske Toplice

49449

Saules Seimos Medicinos Centras JSC, Kaunas

50177

Elite Medicale JSC, Kaunas

51000

Clinical Hospital Centre Rijeka, Rijeka

51014

Tartu University Hospital, Tartu

61039

GI L T Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv

61103

Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway, Kharkiv

SI Institute of General & Emergency Surgery of NAMS of Ukraine, Kharkiv

SMPI Central Clinical Hospital of Ukrzaliznytsia, Kharkiv

61176

CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU, Kharkiv

65025

CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery, Odesa

65026

Multifield Medical Center of Odesa NMU (University Clinic 1), Odesa

69001

CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU, Zaporizhzhya

76018

Ivano-Frankivsk RCCD of MHU Dept of Arterial Hypertension SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk

Ivano-Frankivsk Regional Clinical Cardiology Dispensary, Ivano-Frankivsk

79015

Regional State Clinical Treatment-Diagnostic Cardiological Centre, Lviv

81104

Cardioconsult s r o, Bratislava

82106

DIAMETABOL s r o, Bratislava

85101

Veria s r o, Bratislava

88000

Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU, Uzhhorod

91131

Cardiology and Rehabilitation Clinic JSC, Klaipėda

92231

Klaipeda Republican Hospital Public Institution, Klaipėda

97401

Stredoslovensky ustav srdcovych a cievnych chorob a s, Banská Bystrica

101389

East Tallinn Central Hospital, Tallinn

119620

SBIH of Moscow City Clinical Hospital 17, Moscow

121522

FSBI Russian Cardiological Scientific and Industrial Complex of the MoH of the RF, Moscow

150062

SBIH of Yaroslavl region Regional Clinical Hospital, Yaroslavl

194017

FSBIH SPb Clinical Hospital of RAS, Saint Petersburg

194044

FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine, Saint Petersburg

StP SHI Clinical hospital of St Luka, Saint Petersburg

195067

SBI of HE Northwestern SMU n a I I Mechnikov, Saint Petersburg

195271

"SHI Center of Occupational Pathology", Saint Petersburg

196084

"LLC Institute of Medical Investigations", Saint Petersburg

196601

SPb SBIH City Hospital 38 n a N A Semashko, Pushkin

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

197110

LLC Medical Institute on Krestovsky, Saint Petersburg

197341

North-West Federal Medical Research Center n a V A Almazov, Saint Petersburg

198205

SPb SBIH City Hospital 15, Saint Petersburg

199004

FSBI Saint-Petersburg Multidisciplinary Centre, Saint Petersburg

199106

SPB SHI Pokrovskaya City Hospital, Saint Petersburg

214019

SBEI HPE Smolensk State Medical University of the MoH of the RF, Smolensk

390026

SBI of Ryazan region Regional Clinical Cardiological Dispensary, Ryazan

454048

City Hospital 1, Chelyabinsk

460000

SBEI HPE Orenburg State Medical University of the MoH of the RF, Orenburg

630008

SBIH of Novosibirsk Region Clinical Emergency Hospital 2, Novosibirsk

634012

FSBI Research Institute for Cardiology of Siberian Branch RAMS, Tomsk

644024

Ultramed, Omsk

650002

"FSBI Scientific-research Institute for Complex Problems of cardiovascular disease", Kemerovo

650055

"Dep Clin Hosp on Station Kemerovo of OAO Russian Railways", Kemerovo

650099

"FSHI MSU of MoIA of RF of Kemerovo Region", Kemerovo

656055

TSHI Altay Territorial Cardiologocal dispensary, Barnaul

256 01

Innera s r o, Benešov

743. 01

Poliklinika Humanitas, Bílovec

625 00

Fakultni nemocnice Brno, Brno

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

550 01

Edumed s.r.o, Broumov

580 22

Nemocnice Havlickuv Brod, p.o., Havlíčkův Brod

500 02

Kardio-Pisova, s.r.o., Hradec Králové

280 00

Oblastni nemocnice Kolin, a.s., Kolín

767 01

Centrum pro choroby srdce a cev, Kroměříž

Kromerizska nemocnice, a.s., Kroměříž

353 01

InterKardioML s r o, Mariánské Lázně

530 02

PV - kardiologie s.r.o., Pardubice

101 00

Ordince pro choroby srdce a cev, Prague

110 00

AVICENA -KARDIOLOGIE, INTERNA s.r.o., Prague

Nemocnice na Frantisku, Prague

148 00

Kardio-Pisova sro, Prague

150 06

Fakultni nemocnice v Motole, Prague

158 00

Corintez s.r.o, Prague

261 01

Poliklinika RAVAK, Příbram

261 95

Oblastni nemocnice Pribram, a.s., Příbram

274 01

Nemocnice Slany, Slaný

541 01

Poliklinika Masarykuv Dum, s.r.o., Trutnov

686 01

Clinical Trials Services s.r.o, Uherské Hradiště

760 01

Krajska nemocnice T Bati a s, Zlín

LV-5417

Daugavpils Regional Hospital, Daugavpils

LV-3001

Jelgava Outpatient Clinic, Jelgava

LV-5201

Dr Iveta Neniske GP Practice, Jēkabpils

LV-3301

Dr R Eglite's Private practice, Kuldīga

LV-3401

Inese Cebere GP practice, Liepāja

LV-1002

Pauls Stradins Clinical University Hospital, Riga

LV-1010

Clinic of GP A Lasmanis ALMA, Riga

LV-1011

GK Neiroklinika, Riga

LV-1012

Health Centre 4, Riga

LV-4201

Dr D Harasimjuka GP Practice, Valmiera

LV-3601

Regional Hospital of Ziemelkurzeme, Ventspils

LT-50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics (5103), Kaunas

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

LT-08661

Vilnius University Hospital Santariskiu Clinic Public Institution, Vilnius

15-270

CERMED, Bialystok

15-765

KLIMED Marek Klimkiewicz, Bialystok

82-300

KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp, Elblag

80-382

Synexus Polska SCM Sp z o o Gdansku, Gdansk

81-157

Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman, Gdynia

81-384

Synexus Polska Sp z o o Oddzial w Gdyni, Gdynia

40-040

Synexus Polska Sp z o o Oddzial w Katowicach, Katowice

31-023

Grazyna Pulka Specjalistyczny Osrodek ALL-MED, Krakow

95-054

Centrum Opieki Zdrowotnej Orkan-Med, Ksawerów

32-590

Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak, Libiąż

90-302

Polimedica Centrum Badań Profilaktyki I Leczenia, Lodz

93-153

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi, Lodz

32-600

Medicome Sp z o o, Oświęcim

24-100

SPZOZ w Pulawach Szpital Specjalistyczny, Puławy

41-709

Janusz Spyra Specjalistyczna Praktyka Lekarska, Ruda Śląska

35-006

Centrum Medyczne Sabamed - Rzeszów, Rzeszów

35-055

Centrum Medyczne Medyk, Rzeszów

81-717

NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog, Sopot

70-506

Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez, Szczecin

01-192

Synexus Polska Sp z o o Oddział w Warszawie, Warsaw

50-088

Synexus Polska Sp z o o Oddział we Wroclawiu, Wroclaw

22-400

KO-MED Centra Kliniczne Zamosc, Zamość

18-404

KLIMED Marek Klimkiewicz, Łomża

984 39

KARDIO 1 s r o, Lučenec

01103

Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY