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

Evaluation of Edoxaban in Anticoagulant Naïve Patients With Nonvalvular Atrial Fibrillation (NVAF) and High Creatinine Clearance

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Edoxaban

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • O L V Ziekenhuis
  • Antwerpen, Belgium, 2260
    • ZNA Middelheim
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge
  • Bruxelles, Belgium, 1020
    • C H U Brugmann - Site Victor Horta
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
  • Heusden-Zolder, Belgium, 3550
    • St-Franciskus Ziekenhuis
  • Leuven, Belgium, 3000
    • Universitairsitaire Ziekenhuizen Leuven
  • Liege, Belgium, 4000
    • C H R de la Citadelle
  • Mechelen, Belgium, 2800
    • AZ Sint-Maarten
  • Turnhout, Belgium, 2300
    • AZ Turnhout - Campus Sint-Elisabeth
• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • MHAT 'Sveta Ekaterina' EOOD
  • Gabrovo, Bulgaria, 5300
    • MHAT Dr Tota Venkova AD
  • Haskovo, Bulgaria, 6300
    • Medical Center Haskovo EOOD
  • Haskovo, Bulgaria, 6300
    • MHAT-Haskovo AD
  • Pazardzhik, Bulgaria, 4400
    • MHAT - Pazardzhik AD
  • Pleven, Bulgaria, 5800
    • MHAT Sv Pantaleymon - Pleven OOD
  • Pleven, Bulgaria, 5800
    • SHATC Pleven EAD
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr Georgi Stranski' EAD
  • Plovdiv, Bulgaria, 4000
    • UMHAT Sv Georgi EAD
  • Plovdiv, Bulgaria, 4002
    • MHAT-Plovdiv AD
  • Sofia, Bulgaria, 1606
    • Fourth MHAT - Sofia EAD
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska EAD
  • Sofia, Bulgaria, 1202
    • Second MHAT - Sofia AD
  • Sofia, Bulgaria, 1233
    • Fifth MHAT - Sofia EAD
  • Sofia, Bulgaria, 1233
    • NMTH Tsar Boris III
  • Sofia, Bulgaria, 1309
    • MHAT - National Heart Hospital EAD
  • Sofia, Bulgaria, 1527
    • UMHAT 'Tsaritsa Yoanna - ISUL' EAD
  • Sofia, Bulgaria, 1750
    • UMHAT 'Sveta Anna' AD
  • Varna, Bulgaria, 9000
    • SHATC Cardiolife OOD
• Croatia
  • Dubrovnik, Croatia, 20000
    • General Hospital Dubrovnik
  • Koprivnica, Croatia, 48000
    • General Hospital Dr Tomislav Bardek
  • Krapinske Toplice, Croatia, 49217
    • Special Hospital for medical rehabilitation
  • Rijeka, Croatia, 51000
    • Clinical Hospital Centre Rijeka
  • Slavonski Brod, Croatia, 35000
    • General Hospital Dr Josip Bencevic
  • Varazdin, Croatia, 42000
    • General Hospital Varazdin
  • Zadar, Croatia, 23000
    • General Hospital Zadar
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sveti Duh
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sestre Milosrdnice
  • Zagreb, Croatia, 10000
    • University Hospital center Zagreb (2108)
  • Zagreb, Croatia, 10000
    • University Hospital center Zagreb (2110)
• Czechia
  • Benesov, Czechia, 256 01
    • Innera s r o
  • Bilovec, Czechia, 743. 01
    • Poliklinika Humanitas
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Broumov, Czechia, 550 01
    • EDUMED s.r.o
  • Havlickuv Brod, Czechia, 580 22
    • Nemocnice Havlickuv Brod, p.o.
  • Hradec Kralove, Czechia, 500 02
    • Kardio-Pisova, s.r.o.
  • Kolin, Czechia, 280 00
    • Oblastni nemocnice Kolin, a.s.
  • Kromeriz, Czechia, 767 01
    • Centrum pro choroby srdce a cev
  • Kromeriz, Czechia, 767 01
    • Kromerizska Nemocnice, a.s.
  • Marianske Lazne, Czechia, 353 01
    • InterKardioML s r o
  • Pardubice, Czechia, 530 02
    • PV - kardiologie s.r.o.
  • Prague, Czechia, 158 00
    • Corintez s.r.o
  • Praha, Czechia, 148 00
    • Kardio-Pisova sro
  • Praha 1, Czechia, 110 00
    • AVICENA -KARDIOLOGIE, INTERNA s.r.o.
  • Praha 1, Czechia, 110 00
    • Nemocnice Na Frantisku
  • Praha 10, Czechia, 101 00
    • Ordince pro choroby srdce a cev
  • Praha 5, Czechia, 150 06
    • Fakultni Nemocnice V Motole
  • Pribram 8, Czechia, 261 01
    • Poliklinika RAVAK
  • Příbram, Czechia, 261 95
    • Oblastní nemocnice Příbram, a.s.
  • Slany, Czechia, 274 01
    • Nemocnice Slany
  • Trutnov, Czechia, 541 01
    • Poliklinika Masarykuv Dum, s.r.o.
  • Uherske Hradiste, Czechia, 686 01
    • Clinical Trials Services s.r.o
  • Zlin, Czechia, 760 01
    • Krajska nemocnice T Bati a s
• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjeg og Fredeiksberg Hospital
  • Copenhagen S, Denmark, 2300
    • Amager Hospital
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Holbæk, Denmark, 4300
    • Holbæk Sygehus
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • København Ø, Denmark, 2100
    • Rigshospitalet
  • Nykøbing Falster, Denmark, 4800
    • Nykøbing F Sygehus
  • Slagelse, Denmark, 4200
    • Slagelse Sygehus
  • Viborg, Denmark, 8800
    • Regionshospitalet Viborg
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia, 101389
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 13419
    • Dr Arvo Rosenthal LLC
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• Hungary
  • Baja, Hungary, 6500
    • Principal SMO Kft
  • Bekescsaba, Hungary, 5600
    • Belgyogyaszati es Kardiologiai Maganrendelo
  • Berettyoujfalu, Hungary, 4101
    • Grof Tisza Istvan Korhaz
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Kórház
  • Budapest, Hungary, 1032
    • Szent Margit Kórház
  • Budapest, Hungary, 1023
    • Budai Irgalmasrendi Korhaz
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem
  • Budapest, Hungary, 1021
    • Budapesti Szent Ferenc Korhaz
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Kórház és Rendelőintézet
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem
  • Budapest, Hungary, 1135
    • Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont (4002)
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont (4025)
  • Eger, Hungary, 3300
    • Markhot Ferenc Oktatokorhaz Es Rendelointezet
  • Gyor, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Hodmezovasarhely, Hungary, 6800
    • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
  • Kalocsa, Hungary, 6300
    • Studium Egeszseghaz Kft
  • Kaposvar, Hungary, 7400
    • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Kecskemet, Hungary, 6000
    • Bacs-kiskun Megyei Korhaz
  • Komarom, Hungary, 2921
    • Selye János Kórház
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Korhaz
  • Nyiregyhaza, Hungary, 4400
    • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Szentes, Hungary, 6600
    • Csongrad Megyei Dr Bugyi Istvan Korhaz
  • Veszprem, Hungary, 8200
    • Jeruzsalemhegyi Egeszseghaz
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Kórház
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Daugavpils Regional Hospital
  • Jekabpils, Latvia, LV-5201
    • Dr Iveta Neniske GP Practice
  • Jelgava, Latvia, LV-3001
    • Jelgava Outpatient Clinic
  • Kuldiga, Latvia, LV-3301
    • Dr R Eglite's Private practice
  • Liepaja, Latvia, LV-3401
    • Inese Cebere GP practice
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1010
    • Clinic of GP A Lasmanis ALMA
  • Riga, Latvia, LV-1011
    • GK Neiroklinika
  • Riga, Latvia, LV-1012
    • Health Centre 4
  • Valmiera, Latvia, LV-4201
    • Dr D Harasimjuka GP Practice
  • Ventspils, Latvia, LV-3601
    • Regional Hospital of Ziemelkurzeme
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Kaunas, Lithuania, 47144
    • Kaunas Clinical Hospital Public Institution
  • Kaunas, Lithuania, 49449
    • Saules Seimos Medicinos Centras JSC
  • Kaunas, Lithuania, 50177
    • Elite Medicale JSC
  • Kaunas, Lithuania, LT-50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics (5103)
  • Klaipeda, Lithuania, 91131
    • Cardiology and Rehabilitation Clinic JSC
  • Klaipeda, Lithuania, 92231
    • Klaipeda Republican Hospital Public Institution
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Clinic Public Institution
• Poland
  • Bialystok, Poland, 15-270
    • CERMED
  • Bialystok, Poland, 15-765
    • KLIMED Marek Klimkiewicz
  • Elblag, Poland, 82-300
    • KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp
  • Gdansk, Poland, 80-382
    • Synexus Polska SCM Sp z o o Gdansku
  • Gdynia, Poland, 81-157
    • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman
  • Gdynia, Poland, 81-384
    • Synexus Polska Sp z o o Oddzial w Gdyni
  • Katowice, Poland, 40-040
    • Synexus Polska Sp z o o Oddzial w Katowicach
  • Krakow, Poland, 31-023
    • Grazyna Pulka Specjalistyczny Osrodek All-med
  • Ksawerow, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-Med
  • Libiaz, Poland, 32-590
    • Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak
  • Lodz, Poland, 90-302
    • Polimedica Centrum Badań Profilaktyki I Leczenia
  • Lodz, Poland, 93-153
    • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
  • Lomza, Poland, 18-404
    • KLIMED Marek Klimkiewicz
  • Oswiecim, Poland, 32-600
    • Medicome Sp z o o
  • Pulawy, Poland, 24-100
    • SPZOZ w Pulawach Szpital Specjalistyczny
  • Ruda Slaska, Poland, 41-709
    • Janusz Spyra Specjalistyczna Praktyka Lekarska
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne MEDYK
  • Rzeszow, Poland, 35-006
    • Centrum Medyczne Sabamed - Rzeszów
  • Sopot, Poland, 81-717
    • NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog
  • Szczecin, Poland, 70-506
    • Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez
  • Warszawa, Poland, 01-192
    • Synexus Polska Sp z o o Oddział w Warszawie
  • Wroclaw, Poland, 50-088
    • Synexus Polska Sp z o o Oddział we Wroclawiu
  • Zamosc, Poland, 22-400
    • KO-MED Centra Kliniczne Zamosc
• Russian Federation
  • Barnaul, Russian Federation, 656055
    • TSHI Altay Territorial Cardiologocal dispensary
  • Chelyabinsk, Russian Federation, 454048
    • City Hospital 1
  • Kemerovo, Russian Federation, 650002
    • FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"
  • Kemerovo, Russian Federation, 650055
    • Dep Clin Hosp on Station Kemerovo of OAO "Russian Railways
  • Kemerovo, Russian Federation, 650099
    • FSHI "MSU of MoIA of RF of Kemerovo Region"
  • Moscow, Russian Federation, 119620
    • SBIH of Moscow City Clinical Hospital 17
  • Moscow, Russian Federation, 121522
    • FSBI Russian Cardiological Scientific and Industrial Complex of the MoH of the RF
  • Novosibirsk, Russian Federation, 630008
    • SBIH of Novosibirsk Region Clinical Emergency Hospital 2
  • Omsk, Russian Federation, 644024
    • Ultramed
  • Orenburg, Russian Federation, 460000
    • SBEI HPE Orenburg State Medical University of the MoH of the RF
  • Pushkin, Russian Federation, 196601
    • SPb SBIH City Hospital 38 n a N A Semashko
  • Ryazan', Russian Federation, 390026
    • SBI of Ryazan region Regional Clinical Cardiological Dispensary
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saint Petersburg, Russian Federation, 194017
    • FSBIH SPb Clinical Hospital of RAS
  • Saint Petersburg, Russian Federation, 194044
    • FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine
  • Saint Petersburg, Russian Federation, 194044
    • StP SHI Clinical hospital of St Luka
  • Saint Petersburg, Russian Federation, 195067
    • SBI of HE Northwestern SMU n a I I Mechnikov
  • Saint Petersburg, Russian Federation, 195271
    • SHI "Center of Occupational Pathology"
  • Saint Petersburg, Russian Federation, 196084
    • LLC "Institute of Medical Investigations"
  • Saint Petersburg, Russian Federation, 197110
    • LLC Medical Institute on Krestovsky
  • Saint Petersburg, Russian Federation, 197341
    • North-West Federal Medical Research Center n a V A Almazov
  • Saint Petersburg, Russian Federation, 198205
    • SPb SBIH City Hospital 15
  • Saint Petersburg, Russian Federation, 199004
    • FSBI Saint-Petersburg Multidisciplinary Centre
  • Saint Petersburg, Russian Federation, 199106
    • SPB SHI Pokrovskaya City Hospital
  • Smolensk, Russian Federation, 214019
    • SBEI HPE Smolensk State Medical University of the MoH of the RF
  • Tomsk, Russian Federation, 634012
    • FSBI Research Institute for Cardiology of Siberian Branch RAMS
  • Yaroslavl', Russian Federation, 150062
    • SBIH of Yaroslavl region Regional Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska Kosa
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11040
    • Clinical Center Dr Dragisa Misovic Dedinje
  • Belgrade, Serbia, 11040
    • Dedinje Cardiovascular Institute
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Kragujevac, Serbia, 11000
    • Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • Clinical Center Nis
  • Niska Banja, Serbia, 18205
    • Niska Banja
  • Sremska Kamenica, Serbia, 21204
    • Institute of Cardiovascular Diseases of Vojvodina
• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Stredoslovensky ustav srdcovych a cievnych chorob a s
  • Bardejov, Slovakia, 8501
    • Alian s r o
  • Bratislava, Slovakia, 81104
    • Cardioconsult s r o
  • Bratislava, Slovakia, 82106
    • DIAMETABOL s r o
  • Bratislava, Slovakia, 85101
    • Veria s r o
  • Kosice, Slovakia, 4001
    • Medicalgroup s r o
  • Lucenec, Slovakia, 984 39
    • KARDIO 1 s r o
  • Povazska Bystrica, Slovakia, 1701
    • Kardiologicka ambulancia Dr Kolikova
  • Presov, Slovakia, 8001
    • Medispol s r o
  • Svidnik, Slovakia, 8901
    • Interna SK s r o
  • Zilina, Slovakia, 1001
    • MEDIVASA s r o
• Spain
  • Almeria, Spain, 4120
    • Hospital Virgen del Mar
  • Barcelona, Spain, 8003
    • Hospital del Mar
  • Barcelona, Spain, 8023
    • Hospital Quiron Barcelona
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Sant Boi de Llobregat, Spain, 8830
    • Parc Sanitari Sant Joan de Déu
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Talavera de la Reina, Spain, 45600
    • Hospital Nuestra Señora del Prado
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Cherkasy Regional Cardiological Center
  • Cherkasy, Ukraine, 18009
    • CI Cherkasy RH of Cherkasy Regional Council
  • Ivano-Frankivsk, Ukraine, 76018
    • Ivano-Frankivsk RCCD of MHU Dept of Arterial Hypertension SHEI Ivano-Frankivsk NMU
  • Ivano-Frankivsk, Ukraine, 76018
    • Ivano-Frankivsk Regional Clinical Cardiology Dispensary
  • Kharkiv, Ukraine, 61039
    • GI L T Malaya Therapy National Institute of the NAMS of Ukraine
  • Kharkiv, Ukraine, 61103
    • Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway
  • Kharkiv, Ukraine, 61103
    • SI Institute of General & Emergency Surgery of NAMS of Ukraine
  • Kharkiv, Ukraine, 61103
    • SMPI Central Clinical Hospital of Ukrzaliznytsia
  • Kharkiv, Ukraine, 61176
    • CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU
  • Kyiv, Ukraine, 01103
    • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Kyiv, Ukraine, 2091
    • Kyiv City Clinical Hospital 1
  • Kyiv, Ukraine, 2091
    • Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC
  • Kyiv, Ukraine, 2660
    • SI Heart Institute of the MoH of Ukraine
  • Kyiv, Ukraine, 3680
    • SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102)
  • Kyiv, Ukraine, 3680
    • SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116)
  • Luts'k, Ukraine, 43024
    • CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
  • Lviv, Ukraine, 79015
    • Regional State Clinical Treatment-Diagnostic Cardiological Centre
  • Odesa, Ukraine, 65025
    • CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery
  • Odesa, Ukraine, 65026
    • Multifield Medical Center of Odesa NMU (University Clinic 1)
  • Poltava, Ukraine, 36038
    • First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy
  • Uzhgorod, Ukraine, 88000
    • Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU
  • Vinnytsya, Ukraine, 21018
    • M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1
  • Zaporizhzhya, Ukraine, 69001
    • CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU
  • Zhytomyr, Ukraine, 10003
    • O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC
  • Zhytomyr, Ukraine, 10004
    • CI Central City Hospital 2 of Zhytomyr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)	In pharmacokinetics, steady state means the overall intake of a drug is about equal to its elimination	After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)	Cmin is a term used in pharmacokinetics that usually refers to the minimum blood plasma concentration that a drug achieves after the drug has been administered and prior to the administration of a second dose	After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacodynamics: Mean exposure using validated assays	Exposure analysis performed with validated Liquid Chromatography/Tandem Mass Spectrometry/Mass Spectrometry (LC/MS/MS) assay with lithium heparin plasma. Categories: Edoxaban and its metabolite (D21-2393)	Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay	Exposure analysis performed with anti-FXa assay, using sodium citrate plasma samples Categories: Edoxaban and D21-2393	Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Number of participants with composite event 1	Composite event 1 includes ischemic or hemorrhagic stroke/transient ischemic attack (TIA) and systemic embolic events (SEE)	within 3 years
Efficacy: Number of participants with composite event 2	Composite event 2 includes stroke/TIA, SEE, myocardial infarction, cardiovascular death, and major bleeding	within 3 years
Safety: Number of participants with major bleeding (including intracranial)	Major bleeding is defined per the International Society on Thrombosis and Haemostasis (ISTH) definition	within 3 years
Safety: Number of participants with clinically relevant bleeding	Clinically relevant bleeding is a combination of major bleeding and clinically relevant non-major (CRNM) bleeding	within 3 years
Safety: Number of participants with any bleeding	Count of participants who experienced any bleeding event	within 3 years

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2017
• Primary Completion (Actual): October 9, 2018
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Nonvalvular Atrial Fibrillation; High Creatinine Clearance; Developmental Phase III; Anticoagulant Naïve
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: DU176b-C-E314; 2016-001795-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No