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

NCT ID: NCT02964949

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 607 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-24
• Study Completion Date: 2018-10-09

Brief Summary

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber.

Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete.

Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Edoxaban 75 mg

Edoxaban 60 mg + edoxaban 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

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.

Edoxaban 60 mg

Edoxaban 60 mg + placebo 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.

Group Type: ACTIVE_COMPARATOR

Edoxaban

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meets protocol-specified criteria for qualification
• Is able to follow the protocol specified contraception methods
• Is willing and able to comply with any restrictions related to food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria

• Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

1. the safety or well-being of the participant or study staff

2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)

3. the analysis of results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

O L V Ziekenhuis

Aalst, , Belgium

ZNA Middelheim

Antwerp, , Belgium

AZ Sint-Jan Brugge

Bruges, , Belgium

C H U Brugmann - Site Victor Horta

Brussels, , Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , Belgium

St-Franciskus Ziekenhuis

Heusden-Zolder, , Belgium

Universitairsitaire Ziekenhuizen Leuven

Leuven, , Belgium

C H R de la Citadelle

Liège, , Belgium

AZ Sint-Maarten

Mechelen, , Belgium

AZ Turnhout - Campus Sint-Elisabeth

Turnhout, , Belgium

MHAT 'Sveta Ekaterina' EOOD

Dimitrovgrad, , Bulgaria

MHAT Dr Tota Venkova AD

Gabrovo, , Bulgaria

Medical Center Haskovo EOOD

Haskovo, , Bulgaria

MHAT-Haskovo AD

Haskovo, , Bulgaria

MHAT - Pazardzhik AD

Pazardzhik, , Bulgaria

MHAT Sv Pantaleymon - Pleven OOD

Pleven, , Bulgaria

SHATC Pleven EAD

Pleven, , Bulgaria

UMHAT 'Dr Georgi Stranski' EAD

Pleven, , Bulgaria

UMHAT Sv Georgi EAD

Plovdiv, , Bulgaria

MHAT-Plovdiv AD

Plovdiv, , Bulgaria

Second MHAT - Sofia AD

Sofia, , Bulgaria

Fifth MHAT - Sofia EAD

Sofia, , Bulgaria

NMTH Tsar Boris III

Sofia, , Bulgaria

MHAT - National Heart Hospital EAD

Sofia, , Bulgaria

UMHAT Alexandrovska EAD

Sofia, , Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL' EAD

Sofia, , Bulgaria

Fourth MHAT - Sofia EAD

Sofia, , Bulgaria

UMHAT 'Sveta Anna' AD

Sofia, , Bulgaria

SHATC Cardiolife OOD

Varna, , Bulgaria

General Hospital Dubrovnik

Dubrovnik, , Croatia

General Hospital Dr Tomislav Bardek

Koprivnica, , Croatia

Special Hospital for medical rehabilitation

Krapinske Toplice, , Croatia

Clinical Hospital Centre Rijeka

Rijeka, , Croatia

General Hospital Dr Josip Bencevic

Slavonski Brod, , Croatia

General Hospital Varazdin

Varaždin, , Croatia

General Hospital Zadar

Zadar, , Croatia

Clinical Hospital Center Sestre Milosrdnice

Zagreb, , Croatia

Clinical Hospital Dubrava

Zagreb, , Croatia

Clinical Hospital Sveti Duh

Zagreb, , Croatia

University Hospital center Zagreb (2108)

Zagreb, , Croatia

University Hospital center Zagreb (2110)

Zagreb, , Croatia

Innera s r o

Benešov, , Czechia

Poliklinika Humanitas

Bílovec, , Czechia

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Edumed s.r.o

Broumov, , Czechia

Nemocnice Havlickuv Brod, p.o.

Havlíčkův Brod, , Czechia

Kardio-Pisova, s.r.o.

Hradec Králové, , Czechia

Oblastni nemocnice Kolin, a.s.

Kolín, , Czechia

Centrum pro choroby srdce a cev

Kroměříž, , Czechia

Kromerizska nemocnice, a.s.

Kroměříž, , Czechia

InterKardioML s r o

Mariánské Lázně, , Czechia

PV - kardiologie s.r.o.

Pardubice, , Czechia

Ordince pro choroby srdce a cev

Prague, , Czechia

AVICENA -KARDIOLOGIE, INTERNA s.r.o.

Prague, , Czechia

Nemocnice na Frantisku

Prague, , Czechia

Kardio-Pisova sro

Prague, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Corintez s.r.o

Prague, , Czechia

Poliklinika RAVAK

Příbram, , Czechia

Oblastni nemocnice Pribram, a.s.

Příbram, , Czechia

Nemocnice Slany

Slaný, , Czechia

Poliklinika Masarykuv Dum, s.r.o.

Trutnov, , Czechia

Clinical Trials Services s.r.o

Uherské Hradiště, , Czechia

Krajska nemocnice T Bati a s

Zlín, , Czechia

Bispebjeg og Fredeiksberg Hospital

Copenhagen, , Denmark

Amager Hospital

Copenhagen S, , Denmark

Gentofte Hospital

Hellerup, , Denmark

Herlev Hospital

Herlev, , Denmark

Holbæk Sygehus

Holbæk, , Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Rigshospitalet

København Ø, , Denmark

Nykøbing F Sygehus

Nykøbing Falster, , Denmark

Slagelse Sygehus

Slagelse, , Denmark

Regionshospitalet Viborg

Viborg, , Denmark

East Tallinn Central Hospital

Tallinn, , Estonia

Dr Arvo Rosenthal LLC

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Principal SMO Kft

Baja, , Hungary

Grof Tisza Istvan Korhaz

Berettyóújfalu, , Hungary

Belgyogyaszati es Kardiologiai Maganrendelo

Békéscsaba, , Hungary

Budapesti Szent Ferenc Korhaz

Budapest, , Hungary

Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Szent Margit Korhaz

Budapest, , Hungary

Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet

Budapest, , Hungary

Uzsoki Utcai Korhaz

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont (4002)

Debrecen, , Hungary

Debreceni Egyetem Klinikai Kozpont (4025)

Debrecen, , Hungary

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako

Hódmezővásárhely, , Hungary

Studium Egeszseghaz Kft

Kalocsa, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Bacs-Kiskun Megyei Korhaz

Kecskemét, , Hungary

Selye Janos Korhaz

Komárom, , Hungary

Kanizsai Dorottya Korhaz

Nagykanizsa, , Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Csongrad Megyei Dr Bugyi Istvan Korhaz

Szentes, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Jeruzsalemhegyi Egeszseghaz

Veszprém, , Hungary

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, , Hungary

Daugavpils Regional Hospital

Daugavpils, , Latvia

Jelgava Outpatient Clinic

Jelgava, , Latvia

Dr Iveta Neniske GP Practice

Jēkabpils, , Latvia

Dr R Eglite's Private practice

Kuldīga, , Latvia

Inese Cebere GP practice

Liepāja, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Clinic of GP A Lasmanis ALMA

Riga, , Latvia

GK Neiroklinika

Riga, , Latvia

Health Centre 4

Riga, , Latvia

Dr D Harasimjuka GP Practice

Valmiera, , Latvia

Regional Hospital of Ziemelkurzeme

Ventspils, , Latvia

Kaunas Clinical Hospital Public Institution

Kaunas, , Lithuania

Saules Seimos Medicinos Centras JSC

Kaunas, , Lithuania

Elite Medicale JSC

Kaunas, , Lithuania

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

Kaunas, , Lithuania

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Cardiology and Rehabilitation Clinic JSC

Klaipėda, , Lithuania

Klaipeda Republican Hospital Public Institution

Klaipėda, , Lithuania

Vilnius University Hospital Santariskiu Clinic Public Institution

Vilnius, , Lithuania

CERMED

Bialystok, , Poland

KLIMED Marek Klimkiewicz

Bialystok, , Poland

KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp

Elblag, , Poland

Synexus Polska SCM Sp z o o Gdansku

Gdansk, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman

Gdynia, , Poland

Synexus Polska Sp z o o Oddzial w Gdyni

Gdynia, , Poland

Synexus Polska Sp z o o Oddzial w Katowicach

Katowice, , Poland

Grazyna Pulka Specjalistyczny Osrodek ALL-MED

Krakow, , Poland

Centrum Opieki Zdrowotnej Orkan-Med

Ksawerów, , Poland

Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak

Libiąż, , Poland

Polimedica Centrum Badań Profilaktyki I Leczenia

Lodz, , Poland

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

Lodz, , Poland

Medicome Sp z o o

Oświęcim, , Poland

SPZOZ w Pulawach Szpital Specjalistyczny

Puławy, , Poland

Janusz Spyra Specjalistyczna Praktyka Lekarska

Ruda Śląska, , Poland

Centrum Medyczne Sabamed - Rzeszów

Rzeszów, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog

Sopot, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez

Szczecin, , Poland

Synexus Polska Sp z o o Oddział w Warszawie

Warsaw, , Poland

Synexus Polska Sp z o o Oddział we Wroclawiu

Wroclaw, , Poland

KO-MED Centra Kliniczne Zamosc

Zamość, , Poland

KLIMED Marek Klimkiewicz

Łomża, , Poland

TSHI Altay Territorial Cardiologocal dispensary

Barnaul, , Russia

City Hospital 1

Chelyabinsk, , Russia

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

Kemerovo, , Russia

Dep Clin Hosp on Station Kemerovo of OAO "Russian Railways

Kemerovo, , Russia

FSHI "MSU of MoIA of RF of Kemerovo Region"

Kemerovo, , Russia

SBIH of Moscow City Clinical Hospital 17

Moscow, , Russia

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

Moscow, , Russia

SBIH of Novosibirsk Region Clinical Emergency Hospital 2

Novosibirsk, , Russia

Ultramed

Omsk, , Russia

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

Orenburg, , Russia

SPb SBIH City Hospital 38 n a N A Semashko

Pushkin, , Russia

SBI of Ryazan region Regional Clinical Cardiological Dispensary

Ryazan, , Russia

FSBIH SPb Clinical Hospital of RAS

Saint Petersburg, , Russia

FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine

Saint Petersburg, , Russia

StP SHI Clinical hospital of St Luka

Saint Petersburg, , Russia

SBI of HE Northwestern SMU n a I I Mechnikov

Saint Petersburg, , Russia

SHI "Center of Occupational Pathology"

Saint Petersburg, , Russia

LLC "Institute of Medical Investigations"

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

LLC Medical Institute on Krestovsky

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

SPb SBIH City Hospital 15

Saint Petersburg, , Russia

FSBI Saint-Petersburg Multidisciplinary Centre

Saint Petersburg, , Russia

SPB SHI Pokrovskaya City Hospital

Saint Petersburg, , Russia

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

Smolensk, , Russia

FSBI Research Institute for Cardiology of Siberian Branch RAMS

Tomsk, , Russia

SBIH of Yaroslavl region Regional Clinical Hospital

Yaroslavl, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, , Serbia

Dedinje Cardiovascular Institute

Belgrade, , Serbia

Clinical Center Bezanijska kosa

Belgrade, , Serbia

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

Niska Banja

Niška Banja, , Serbia

Stredoslovensky ustav srdcovych a cievnych chorob a s

Banská Bystrica, , Slovakia

Alian s r o

Bardejov, , Slovakia

Cardioconsult s r o

Bratislava, , Slovakia

DIAMETABOL s r o

Bratislava, , Slovakia

Veria s r o

Bratislava, , Slovakia

Medicalgroup s r o

Košice, , Slovakia

KARDIO 1 s r o

Lučenec, , Slovakia

Kardiologicka ambulancia Dr Kolikova

Považská Bystrica, , Slovakia

Medispol s r o

Prešov, , Slovakia

Interna SK s r o

Svidník, , Slovakia

MEDIVASA s r o

Žilina, , Slovakia

Hospital Virgen del Mar

Almería, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Quiron Barcelona

Barcelona, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario Clinico San Carlos

Madrid, , Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Parc Sanitari Sant Joan de Deu

Sant Boi de Llobregat, , Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Nuestra Señora del Prado

Talavera de la Reina, , Spain

Cherkasy Regional Cardiological Center

Cherkasy, , Ukraine

CI Cherkasy RH of Cherkasy Regional Council

Cherkasy, , Ukraine

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

Ivano-Frankivsk, , Ukraine

Ivano-Frankivsk Regional Clinical Cardiology Dispensary

Ivano-Frankivsk, , Ukraine

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

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

SI Institute of General & Emergency Surgery of NAMS of Ukraine

Kharkiv, , Ukraine

SMPI Central Clinical Hospital of Ukrzaliznytsia

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

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

Kyiv, , Ukraine

Kyiv City Clinical Hospital 1

Kyiv, , Ukraine

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

Kyiv, , Ukraine

SI Heart Institute of the MoH of Ukraine

Kyiv, , Ukraine

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

Kyiv, , Ukraine

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

Kyiv, , Ukraine

CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis

Lutsk, , Ukraine

Regional State Clinical Treatment-Diagnostic Cardiological Centre

Lviv, , Ukraine

CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery

Odesa, , Ukraine

Multifield Medical Center of Odesa NMU (University Clinic 1)

Odesa, , Ukraine

First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy

Poltava, , Ukraine

Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU

Uzhhorod, , Ukraine

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

Vinnytsia, , Ukraine

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

Zaporizhzhya, , Ukraine

O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC

Zhytomyr, , Ukraine

CI Central City Hospital 2 of Zhytomyr

Zhytomyr, , Ukraine

Countries

Belgium; Bulgaria; Croatia; Czechia; Denmark; Estonia; Hungary; Latvia; Lithuania; Poland; Russia; Serbia; Slovakia; Spain; Ukraine

Other Identifiers

2016-001795-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DU176b-C-E314

Identifier Type: -

Identifier Source: org_study_id