AzTrials
AzTrials

Atrial FibrillationNCT02964949

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

A study testing Edoxaban in people with Atrial Fibrillation, run by Daiichi Sankyo at 233 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Edoxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
607 participants
Where
233 sitesin 15 countries
Study dates
24 Jan 2017to 9 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Trial locations and contacts

233 sites in 15 countries.

233 sites in 15 countries

Hungary29 sites

  • Principal SMO Kft

    Baja, 6500

  • Belgyogyaszati es Kardiologiai Maganrendelo

    Békéscsaba, 5600

  • Grof Tisza Istvan Korhaz

    Berettyóújfalu, 4101

  • Budapesti Szent Ferenc Korhaz

    Budapest, 1021

  • Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Szent Margit Korhaz

    Budapest, 1032

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Semmelweis Egyetem

    Budapest, 1122

  • Semmelweis Egyetem

    Budapest, 1125

  • Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet

    Budapest, 1135

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont (4002)

    Debrecen, 4032

  • Debreceni Egyetem Klinikai Kozpont (4025)

    Debrecen, 4032

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako

    Hódmezővásárhely, 6800

  • Studium Egeszseghaz Kft

    Kalocsa, 6300

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, 6000

  • Selye Janos Korhaz

    Komárom, 2921

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, 8800

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Csongrad Megyei Dr Bugyi Istvan Korhaz

    Szentes, 6600

  • Jeruzsalemhegyi Egeszseghaz

    Veszprém, 8200

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Russia27 sites

  • TSHI Altay Territorial Cardiologocal dispensary

    Barnaul, 656055

  • City Hospital 1

    Chelyabinsk, 454048

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

    Kemerovo, 650002

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

    Kemerovo, 650055

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

    Kemerovo, 650099

  • SBIH of Moscow City Clinical Hospital 17

    Moscow, 119620

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

    Moscow, 121522

  • SBIH of Novosibirsk Region Clinical Emergency Hospital 2

    Novosibirsk, 630008

  • Ultramed

    Omsk, 644024

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

    Orenburg, 460000

  • SPb SBIH City Hospital 38 n a N A Semashko

    Pushkin, 196601

  • SBI of Ryazan region Regional Clinical Cardiological Dispensary

    Ryazan, 390026

  • FSBIH SPb Clinical Hospital of RAS

    Saint Petersburg, 194017

  • FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine

    Saint Petersburg, 194044

  • StP SHI Clinical hospital of St Luka

    Saint Petersburg, 194044

  • SBI of HE Northwestern SMU n a I I Mechnikov

    Saint Petersburg, 195067

  • SHI "Center of Occupational Pathology"

    Saint Petersburg, 195271

  • LLC "Institute of Medical Investigations"

    Saint Petersburg, 196084

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • LLC Medical Institute on Krestovsky

    Saint Petersburg, 197110

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

    Saint Petersburg, 197341

  • SPb SBIH City Hospital 15

    Saint Petersburg, 198205

  • FSBI Saint-Petersburg Multidisciplinary Centre

    Saint Petersburg, 199004

  • SPB SHI Pokrovskaya City Hospital

    Saint Petersburg, 199106

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

    Smolensk, 214019

  • FSBI Research Institute for Cardiology of Siberian Branch RAMS

    Tomsk, 634012

  • SBIH of Yaroslavl region Regional Clinical Hospital

    Yaroslavl, 150062

Other trials in Russia

Ukraine25 sites

  • Cherkasy Regional Cardiological Center

    Cherkasy, 18009

  • CI Cherkasy RH of Cherkasy Regional Council

    Cherkasy, 18009

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

    Ivano-Frankivsk, 76018

  • Ivano-Frankivsk Regional Clinical Cardiology Dispensary

    Ivano-Frankivsk, 76018

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

    Kharkiv, 61039

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

    Kharkiv, 61103

  • SI Institute of General & Emergency Surgery of NAMS of Ukraine

    Kharkiv, 61103

  • SMPI Central Clinical Hospital of Ukrzaliznytsia

    Kharkiv, 61103

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

    Kharkiv, 61176

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

    Kyiv, 01103

  • Kyiv City Clinical Hospital 1

    Kyiv, 2091

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

    Kyiv, 2091

  • SI Heart Institute of the MoH of Ukraine

    Kyiv, 2660

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

    Kyiv, 3680

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

    Kyiv, 3680

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

    Lutsk, 43024

  • Regional State Clinical Treatment-Diagnostic Cardiological Centre

    Lviv, 79015

  • CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery

    Odesa, 65025

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

    Odesa, 65026

  • First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy

    Poltava, 36038

  • Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU

    Uzhhorod, 88000

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

    Vinnytsia, 21018

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

    Zaporizhzhya, 69001

  • O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC

    Zhytomyr, 10003

  • CI Central City Hospital 2 of Zhytomyr

    Zhytomyr, 10004

Other trials in Ukraine

Czechia24 sites

  • Innera s r o

    Benešov, 256 01

  • Poliklinika Humanitas

    Bílovec, 743. 01

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Edumed s.r.o

    Broumov, 550 01

  • Nemocnice Havlickuv Brod, p.o.

    Havlíčkův Brod, 580 22

  • Kardio-Pisova, s.r.o.

    Hradec Králové, 500 02

  • Oblastni nemocnice Kolin, a.s.

    Kolín, 280 00

  • Centrum pro choroby srdce a cev

    Kroměříž, 767 01

  • Kromerizska nemocnice, a.s.

    Kroměříž, 767 01

  • InterKardioML s r o

    Mariánské Lázně, 353 01

  • PV - kardiologie s.r.o.

    Pardubice, 530 02

  • Ordince pro choroby srdce a cev

    Prague, 101 00

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

    Prague, 110 00

  • Nemocnice na Frantisku

    Prague, 110 00

  • Kardio-Pisova sro

    Prague, 148 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Corintez s.r.o

    Prague, 158 00

  • Poliklinika RAVAK

    Příbram, 261 01

  • Oblastni nemocnice Pribram, a.s.

    Příbram, 261 95

  • Nemocnice Slany

    Slaný, 274 01

  • Poliklinika Masarykuv Dum, s.r.o.

    Trutnov, 541 01

  • Clinical Trials Services s.r.o

    Uherské Hradiště, 686 01

  • Krajska nemocnice T Bati a s

    Zlín, 760 01

Other trials in Czechia

Poland23 sites

  • CERMED

    Bialystok, 15-270

  • KLIMED Marek Klimkiewicz

    Bialystok, 15-765

  • KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp

    Elblag, 82-300

  • Synexus Polska SCM Sp z o o Gdansku

    Gdansk, 80-382

  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman

    Gdynia, 81-157

  • Synexus Polska Sp z o o Oddzial w Gdyni

    Gdynia, 81-384

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40-040

  • Grazyna Pulka Specjalistyczny Osrodek ALL-MED

    Krakow, 31-023

  • Centrum Opieki Zdrowotnej Orkan-Med

    Ksawerów, 95-054

  • Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak

    Libiąż, 32-590

  • Polimedica Centrum Badań Profilaktyki I Leczenia

    Lodz, 90-302

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

    Lodz, 93-153

  • KLIMED Marek Klimkiewicz

    Łomża, 18-404

  • Medicome Sp z o o

    Oświęcim, 32-600

  • SPZOZ w Pulawach Szpital Specjalistyczny

    Puławy, 24-100

  • Janusz Spyra Specjalistyczna Praktyka Lekarska

    Ruda Śląska, 41-709

  • Centrum Medyczne Sabamed - Rzeszów

    Rzeszów, 35-006

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog

    Sopot, 81-717

  • Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez

    Szczecin, 70-506

  • Synexus Polska Sp z o o Oddział w Warszawie

    Warsaw, 01-192

  • Synexus Polska Sp z o o Oddział we Wroclawiu

    Wroclaw, 50-088

  • KO-MED Centra Kliniczne Zamosc

    Zamość, 22-400

Other trials in Poland

Bulgaria19 sites

  • MHAT 'Sveta Ekaterina' EOOD

    Dimitrovgrad, 6400

  • MHAT Dr Tota Venkova AD

    Gabrovo, 5300

  • Medical Center Haskovo EOOD

    Haskovo, 6300

  • MHAT-Haskovo AD

    Haskovo, 6300

  • MHAT - Pazardzhik AD

    Pazardzhik, 4400

  • MHAT Sv Pantaleymon - Pleven OOD

    Pleven, 5800

  • SHATC Pleven EAD

    Pleven, 5800

  • UMHAT 'Dr Georgi Stranski' EAD

    Pleven, 5800

  • UMHAT Sv Georgi EAD

    Plovdiv, 4000

  • MHAT-Plovdiv AD

    Plovdiv, 4002

  • Second MHAT - Sofia AD

    Sofia, 1202

  • Fifth MHAT - Sofia EAD

    Sofia, 1233

  • NMTH Tsar Boris III

    Sofia, 1233

  • MHAT - National Heart Hospital EAD

    Sofia, 1309

  • UMHAT Alexandrovska EAD

    Sofia, 1431

  • UMHAT 'Tsaritsa Yoanna - ISUL' EAD

    Sofia, 1527

  • Fourth MHAT - Sofia EAD

    Sofia, 1606

  • UMHAT 'Sveta Anna' AD

    Sofia, 1750

  • SHATC Cardiolife OOD

    Varna, 9000

Other trials in Bulgaria

Croatia12 sites

  • General Hospital Dubrovnik

    Dubrovnik, 20000

  • General Hospital Dr Tomislav Bardek

    Koprivnica, 48000

  • Special Hospital for medical rehabilitation

    Krapinske Toplice, 49217

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • General Hospital Dr Josip Bencevic

    Slavonski Brod, 35000

  • General Hospital Varazdin

    Varaždin, 42000

  • General Hospital Zadar

    Zadar, 23000

  • Clinical Hospital Center Sestre Milosrdnice

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • Clinical Hospital Sveti Duh

    Zagreb, 10000

  • University Hospital center Zagreb (2108)

    Zagreb, 10000

  • University Hospital center Zagreb (2110)

    Zagreb, 10000

Other trials in Croatia

Latvia11 sites

  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

  • Dr Iveta Neniske GP Practice

    Jēkabpils, LV-5201

  • Jelgava Outpatient Clinic

    Jelgava, LV-3001

  • Dr R Eglite's Private practice

    Kuldīga, LV-3301

  • Inese Cebere GP practice

    Liepāja, LV-3401

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Clinic of GP A Lasmanis ALMA

    Riga, LV-1010

  • GK Neiroklinika

    Riga, LV-1011

  • Health Centre 4

    Riga, LV-1012

  • Dr D Harasimjuka GP Practice

    Valmiera, LV-4201

  • Regional Hospital of Ziemelkurzeme

    Ventspils, LV-3601

Other trials in Latvia

Slovakia11 sites

  • Stredoslovensky ustav srdcovych a cievnych chorob a s

    Banská Bystrica, 97401

  • Alian s r o

    Bardejov, 8501

  • Cardioconsult s r o

    Bratislava, 81104

  • DIAMETABOL s r o

    Bratislava, 82106

  • Veria s r o

    Bratislava, 85101

  • Medicalgroup s r o

    Košice, 4001

  • KARDIO 1 s r o

    Lučenec, 984 39

  • Kardiologicka ambulancia Dr Kolikova

    Považská Bystrica, 1701

  • Medispol s r o

    Prešov, 8001

  • Interna SK s r o

    Svidník, 8901

  • MEDIVASA s r o

    Žilina, 1001

Other trials in Slovakia

Belgium10 sites

  • O L V Ziekenhuis

    Aalst, 9300

  • ZNA Middelheim

    Antwerp, 2260

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • C H U Brugmann - Site Victor Horta

    Brussels, 1020

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • St-Franciskus Ziekenhuis

    Heusden-Zolder, 3550

  • Universitairsitaire Ziekenhuizen Leuven

    Leuven, 3000

  • C H R de la Citadelle

    Liège, 4000

  • AZ Sint-Maarten

    Mechelen, 2800

  • AZ Turnhout - Campus Sint-Elisabeth

    Turnhout, 2300

Other trials in Belgium

Denmark10 sites

  • Bispebjeg og Fredeiksberg Hospital

    Copenhagen, 2400

  • Amager Hospital

    Copenhagen S, 2300

  • Gentofte Hospital

    Hellerup, 2900

  • Herlev Hospital

    Herlev, 2730

  • Holbæk Sygehus

    Holbæk, 4300

  • Hvidovre Hospital

    Hvidovre, 2650

  • Rigshospitalet

    København Ø, 2100

  • Nykøbing F Sygehus

    Nykøbing Falster, 4800

  • Slagelse Sygehus

    Slagelse, 4200

  • Regionshospitalet Viborg

    Viborg, 8800

Other trials in Denmark

Serbia10 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Dr Dragisa Misovic Dedinje

    Belgrade, 11040

  • Dedinje Cardiovascular Institute

    Belgrade, 11040

  • Clinical Center Bezanijska kosa

    Belgrade, 11080

  • Institute of Cardiovascular Diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

  • Niska Banja

    Niška Banja, 18205

Other trials in Serbia

Spain10 sites

  • Hospital Virgen del Mar

    Almería, 4120

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Quiron Barcelona

    Barcelona, 8023

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Parc Sanitari Sant Joan de Deu

    Sant Boi de Llobregat, 8830

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Nuestra Señora del Prado

    Talavera de la Reina, 45600

Other trials in Spain

Lithuania8 sites

  • Kaunas Clinical Hospital Public Institution

    Kaunas, 47144

  • Saules Seimos Medicinos Centras JSC

    Kaunas, 49449

  • Elite Medicale JSC

    Kaunas, 50177

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

    Kaunas, LT-50009

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Cardiology and Rehabilitation Clinic JSC

    Klaipėda, 91131

  • Klaipeda Republican Hospital Public Institution

    Klaipėda, 92231

  • Vilnius University Hospital Santariskiu Clinic Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Estonia4 sites

  • East Tallinn Central Hospital

    Tallinn, 101389

  • Dr Arvo Rosenthal LLC

    Tallinn, 13419

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

About this study

Official title: 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).

Being tested
Edoxaban
Keywords
Nonvalvular Atrial Fibrillation, High Creatinine Clearance, Developmental Phase III, Anticoagulant Naïve
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

    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.

Study groups in NCT02964949
Study groupRoleWhat they receive
Edoxaban 75 mgExperimentalEdoxaban 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.
Receives: Drug: Edoxaban
Edoxaban 60 mgActive comparatorEdoxaban 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.
Receives: Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

  2. 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

    Measured: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)

  3. 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)

    Measured: 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)

  4. 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

    Measured: 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 outcomes (5)

  1. 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)

    Measured: within 3 years

  2. Efficacy: Number of participants with composite event 2

    Composite event 2 includes stroke/TIA, SEE, myocardial infarction, cardiovascular death, and major bleeding

    Measured: within 3 years

  3. Safety: Number of participants with major bleeding (including intracranial)

    Major bleeding is defined per the International Society on Thrombosis and Haemostasis (ISTH) definition

    Measured: within 3 years

  4. Safety: Number of participants with clinically relevant bleeding

    Clinically relevant bleeding is a combination of major bleeding and clinically relevant non-major (CRNM) bleeding

    Measured: within 3 years

  5. Safety: Number of participants with any bleeding

    Count of participants who experienced any bleeding event

    Measured: within 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2016 (estimated)
  2. Study start24 Jan 2017
  3. Primary completion9 Oct 2018
  4. Study completion9 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
607 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964949
Sponsor's protocol ID
DU176b-C-E314
Other IDs
2016-001795-30, 2016
Status last verified
Dec 2018
First submitted
14 Nov 2016
Last updated
12 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A study testing Edoxaban in people with Atrial Fibrillation, run by Daiichi Sankyo at 233 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 233 sites in Hungary, Russia, Ukraine, Czechia, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav) (time frame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02964949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.

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