Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

PHASE3CompletedINTERVENTIONAL
Enrollment

21,105

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

April 30, 2013

Study Completion Date

May 31, 2013

Conditions
StrokeAtrial FibrillationEmbolism
Interventions
DRUG

warfarin tablets

Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months

DRUG

Edoxaban tablets (high dose regimen-60mg)

Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

DRUG

Edoxaban tablets (low dose regimen-30mg)

Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

DRUG

placebo warfarin

placebo warfarin

DRUG

placebo edoxaban

placebo edoxaban

Trial Locations (1009)

16602

Altoona

19522

Fleetwood

23294

Richmond

23502

Norfolk

27408

Greensboro

28207

Charlotte

28557

Morehead City

28655

Morganton

29302

Spartanburg

29651

Greer

30013

Conyers

30039

Snellville

30188

Woodstock

32114

Daytona Beach

33173

Miami

33484

Delray Beach

34748

Leesburg

45505

Springfield

68025

Fremont

71291

West Monroe

80904

Colorado Springs

82220

Belleville

84120

West Valley City

85283

Tempe

85635

Sierra Vista

Unknown

Birmingham

Mobile

Gilbert

Glendale

Lake Havasu City

Tucson

Harrisburg

Hot Springs

Little Rock

Alhambra

Anaheim

Burbank

Chula Vista

Encinitas

Fountain Valley

Glendale

Healdsburg

Lakewood

Long Beach

Los Alamitos

Los Angeles

Los Banos

Mather

Merced

Newport Beach

Oceanside

Pacific Palisades

Palm Springs

Pismo Beach

Redondo Beach

Sacramento

San Diego

Santa Rosa

Torrance

Ventura

Aurora

Denver

Englewood

Greeley

Bridgeport

Guilford

Hamden

Manchester

New Haven

North Haven

Shelton

Stamford

Trumbull

Newark

Washington D.C.

Aventura

Chipley

Clearwater

Daytona Beach

DeBary

Deerfield Beach

Delray Beach

Hialeah

Hollywood

Jacksonville

Jacksonville Beach

Jupiter

Melbourne

Miami

Naples

Orange Park

Orlando

Ormond Beach

Panama City

Pembroke Pines

Pensacola

Plantation

Port Charlotte

Rockledge

Saint Augustine

Sarasota

St. Petersburg

Stuart

Tamarac

Tampa

The Villages

Vero Beach

West Palm Beach

Athens

Atlanta

Covington

Cumming

Savannah

Tucker

Watkinsville

Waycross

Honolulu

Boise

Hayden Lake

Bannockburn

Chicago

Elgin

Joliet

Libertyville

Maywood

Melrose Park

Oak Lawn

Springfield

Winfield

Bloomington

Munster

Ames

Council Bluffs

Iowa City

Shell Rock

Wichita

Bowling Green

Campbellsville

Elizabethtown

Richmond

Marrero

West Monroe

Auburn

Biddeford

Baltimore

Bel Air

Bethesda

Lexington Park

Rockville

Salisbury

Towson

Westminster

Ayer

Boston

Concord

East Bridgewater

Haverhill

Methuen

Worcester

Bay City

Benzonia

Chelsea

Commerce

Detroit

Grand Rapids

Interlochen

Kalamazoo

Lapeer

Midland

Rochester Hills

Saginaw

Troy

Warren

Golden Valley

Minneapolis

Saint Paul

Biloxi

Chesterfield

Joplin

Kansas City

Saint Charles

St Louis

Kalispell

Grand Island

Lincoln

Omaha

Henderson

Belvidere

Brick

Bridgewater

Browns Mills

Cherry Hill

Elizabeth

Haddon Heights

Hamilton

Mine Hill

Ocean City

Passaic

Ridgewood

Somerset

Toms River

Albuquerque

Albany

Brooklyn

Buffalo

Cortlandt Manor

Hawthorne

Jamaica

Mineola

New York

North Massapequa

Saratoga Springs

Troy

Cary

Chapel Hill

Mooresville

Morganton

Oxford

Pinehurst

Statesville

Winston-Salem

Fargo

Oakes

Akron

Canal Fulton

Canton

Cincinnati

Cleveland

Columbus

Cuyahoga Falls

Dayton

Fairfield

Marion

Middletown

Pitsburg

Thornville

Toledo

Willoughby Hills

Bartlesville

Oklahoma City

Bend

Corvallis

Beaver

Chester

Clymer

Danville

Doylestown

Ephrata

Feasterville

Greenville

Johnstown

Lancaster

Lewistown

Newport

Norristown

Philadelphia

Pittsburgh

Pottstown

Scranton

Sellersville

Somerset

State College

Uniontown

Wilkes-Barre

Wynnewood

Yardley

Providence

Anderson

Charleston

Columbia

Florence

Greenville

Mt. Pleasant

Summerville

Taylors

Walterboro

Rapid City

Columbia

Jackson

Johnson City

Nashville

Oak Ridge

Arlington

Austin

Carrollton

Corsicana

Dallas

Fort Worth

Georgetown

Grapevine

Houston

Lubbock

McAllen

Odessa

Plano

San Antonio

Tomball

Wichita Falls

Provo

Danville

Hopewell

Newport News

Springfield

Suffolk

Virginia Beach

Winchester

Bellevue

Kirkland

Renton

Seattle

Spokane

Tacoma

Clarksburg

Madison

Manitowoc

Menomonee Falls

Bahía Blanca

Buenos Aires

Corrientes

Córdoba

Formosa

Godoy Cruz

Mar del Plata

Mendoza

Paraguay

Provincia de Chaco

Provincia de Rio Negro

Provincia de Salta

San Luis

San Miguel de Tucumán

San Salvador de Jujuy

Santa Fe

Sante Fe

Broken Hill

East Gosford

Carina Heights

Milton

Adelaide

Frankston

Ashford

Camperdown

Elizabeth Vale

Joondalup

Melbourne

Parkville

Perth

Antwerp

Arlon

Bruges

Brussels

Genk

Hasselt

Leuven

Liège

Mechelen

Merksem

Moerkerke

Montegnée

Mousron

Torhout

Veurne

Wetteren

Belo Horizonte

Blumenau

Brasília

Campina Grande do Sul

Campinas

Caxias do Sul

Curitiba

Goiânia

Lajeados

Maceió

Marília

Passo Fundo

Porto Alegre

Recife

Ribeirão Preto

Rio de Janeiro

Salvador

Santo André

São José

São Paulo

Uberlândia

Burgas

Dimitrovgrad

Haskovo

Pleven

Plovdiv

Rousse

Sofia

Varna

Calgary

Campbell River

Chilliwack

Coquitlam

Kamloops

Kelowna

New Westminster

Penticton

Quesnel

Victoria

Saint John

Bridgewater

Halifax

Liverpool

Ajax

Beamsville

Brampton

Corunna

Greater Sudbury

Hamilton

Kitchener

Listowel

London

Oshawa

Ottawa

Richmond Hill

Sarnia

Scarborough Village

Toronto

Greenfield Park

Longueuil

Montreal

Québec

Saint Georges de Beauce

Saint-Charles-Borromée

Saint-Jérôme

Saint-Lambert

Terrebonne

Trois-Rivières

Westmount

Saskatoon

Mount Pearl

St. John's

Iquique

La Serena

Osorno

Port Montt

Rancagua

Santiago

Talcahuano

Temuco

Victoria

Viña del Mar

Baotou

Beijing

Changchun

Changsha

Chendu

Chongqing

Guangxi

Guangzhou

Hainan Province

Hangzhou

Harbin

Jinzhou

Lanzhou

Liaoning Province

Nanchang

Shaanxi Province

Shanghai

Shenyang

Shijiazhuang

Tianjin

Wenzhou

Wuhan

Antioquia

Armenia

Barranquilla

Bogotá

Bucaramanga

Cartagena

Envigado

Manizales

Medellín

Dubrovnik

Karlovac

Koprivnica

Krapinski Toplice

Osijek

Rijeka

Slavonski Brod

Split

Varaždin

Zadar

Zagreb

Benátky nad Jizerou

Benešov

Bílovec

Brno

Brno-Lesna

Chrudim

Český Krumlov

Havlickux Brod

Hradec Králové

Hranice

Jindřichův Hradec

Kolín

Kroměříž

Mariánské Lázně

Mladá Boleslav

Náchod

Ostrava

Ostrava-Trebovice

Pardubice

Pilsen

Prague

Příbram

Řevnice

Semily

Slaný

Teplice

Trutnov

Ústí nad Labem

Aarhus N

Copenhagen

Esbjerg

Frederiksberg

Glostrup Municipality

Hellerup

Holbæk

Horsens

Haabneeme

Puusepa

Pärnu

Tallinn

Tartu

Jyväskylä

Kuopio

Lappeenranta

Oulu

Seinäjoki

Tampere

Abbeville

Amiens

Brest

Cambrai

Clamart

La Roche-sur-Yon

Lille

Lyon

Massy

Nantes

Paris

Pau

Pessac

Poitiers

Tours

Valenciennes

Altenburg

Aschaffenburg

Augsburg

Bad Nauheim

Berlin

Bochum

Cloppenburg

Cologne

Dortmund

Dresden

Essen

Frankfurt

Giengen an der Brenz

Görlitz

Großheirath

Hamburg

Heidelberg

Heilbronn

Homburg

Ingelheim

Kallstadt

Kassel

Kiel-Kronshagen

Leipzig

Ludwigshafen

Lübeck

Magdeburg

Mainz

Mannheim

Markkleeberg

München

Nienburg

Northeinm

Offenbach-beiber

Potsdam

Rüdersdorf

Siegen

Stuhr

Ulm

Unterschneidheim

Wardenburg

Wermsdorf

Weyhe

Witten

Woerishofen

Wuppertal

Athens

Larissa

Rhodes

Rio-Patras

Thessaloniki

Trikala

Voula

Ciudad

Clinica

Edificio Multimedica

Nivel

Oficina

Quetzaltenango

Zacapa

Ajka

Baja

Békéscsaba

Budapest

Debrecen

Hódmezővásárhely

Kecskemét

Keeskemet

Kistarcsa

Komárom

Makó

Nagykanizsa

Nyíregyháza

Pécs

Sopron

Szekszárd

Szombathely

Zalaegerszeg

Hyderabad

Vijayawada

Angamaly

Kochi

Thrissur

Ahmedabad

Anddhra Pradesh

Andhra Pradesh

Aurangabad

Bangalore

Bikaner

Chennai

Coimbatore

Delhi

Gujrāt

Indore

Jaipur

Karnataka

Kerala

Kolkata

Ludhiana

Madhya Pradesh

Maharashtra

Mangalore

Mumbai

Nagpur

Nashik

New Delhi

Pune

Punjab

Pūni

Rajasthan

Ramnagar

Shimoga

Surat

Trivandrum

Vadodara

Afula

Beersheba

Dimona

Giv‘atayim

Hadera

Haifa

Holon

Jerusalem

Kfar Saba

Nahariya

Nazareth

Petah Tikva

Poria – Neve Oved

Raanana

Rehovot

Tel Aviv

Tel Litwinsky

Ẕerifin

Bologna

Brescia

Cantania

Casarano

Caserta

Chieti

Cremona

Genova

Grosseto

Legnano

Manerbio

Milan

Monserrato

Napoli

Novara

Ostia Antica

Pavia

Pisa

Pozzuoli

Roma

Santa Maria Capua Vetere

Sassari

Seriate

Siena

Trieste

Venezia Mestre

Kyoto

Lida-shi

Ueda-shi

Minato-ku

Aichi

Aomori

Chiaki

Chiba

Ehime

Fukuoka

Fukushima

Gifu

Gunma

Hiroshima

Hokkai-do

Hokkaido

Hyōgo

Ibaraki

Isesaki-shi

Ishikawa

Kagawa

Kanagawa

Kumamoto

Kyoda

Mie

Miyagi

Nagaoka-shi

Nagasaki

Niigata

Numakunai

Okayama

Osaka

Saitama

Shimane

Shizuoka

Tokushima

Tokyo

Yamaguchi

Yokohama

Guadalajara

Xalapa

Aguascalientes

Chihuahua City

Distrito Federal

Durango

Monterrey

San Luis Potosí City

Yucatán

Almere Stad

Amstelveen

Amsterdam

Dordrecht

Eindhoven

Ewijk

Leiderdorp

Maastricht

Rotterdam

Venlo

Wildervlank

Lower Hutt

Auckland

Christchurch

Dunedin

Hamilton

Nelson

Tauranga

Bodø

Harstad

Haugesund

Oslo

Rud

Arequipa

Callao

Lima

Cebu

Cebu City

Davao City

Pasig

Quezon City

Ostrów

Bydgoszcz

Chojnice

Elblag

Ełk

Gdansk

Inowrocław

Jarosław

Katowice

Komenskiego

Kołobrzeg

Krakow

Kutno

Libiąż

Lodz

Lubartów

Lublin

Pomorskie

Puławy

Płock

Ruda Śląska

Rzeszów

Skierniewice

Sopot

Sucharskiego

Szczecin

Tarnów

Torun

Warsaw

Warzawa

Wroclaw

Amadora

Aveiro

Braga

Coimbra

Leiria

Lisbon

Ponta Delgada

Setúbal

Viseu

Bacau

Brasov

Brăila

Buccuresti

Bucharest

Buzău

Covasna

Dambovita

Iași

Judetul Maramures

Judetul Mures

Judetul Suceava

Judetul Vrancea

Oradea

Timișoara

Barnaul

Chelyabinsk

Kemerovo

Krasnoyarsk

Moscow

Nizhny Novgorod

Novosibirsk

Omsk

Orenburg

Perm

Ryazan

Saint Petersburg

Saratov

Smolensk

Tula

Tyumen

Volgograd

Voronezh

Yaroslavl

Belgrade

Kamenitz

Niš

Niška Banja

Zemun

Zmaj Jovina

Bardejov

Bratislava

Dolný Kubín

Galanta

Košice

Levice

Lučenec

Nitra

Nové Zámky

Prešov

Rimavská Sobota

Alberton

Benoni

Bloemfontein

Cape Town

Diepkloof

Durban

Lyttelton

Parktown West

Port Elizabeth

Potchefstroom

Pretoria

Somerset West

Worcester

Busan

Daegu

Daejeon

Gangwon-do

Gwangju

Gyeonggi-do

Incheon

Pusan

Seoul

A Coruña

Alcoy

Almería

Barcelona

Bilbao

De La Castellana

Donostia / San Sebastian

Figueras

Jaén

Lleida

Madrid

Murcia

Santiago de Compostela

Seville

Vigo

Vitoria-Gasteiz

Alingsås

Enköping

Gothenburg

Halmstad

Karlshamn

Köping

Lindesberg

Luleå

Lund

Malmo

Mora

Mölndal

Örebro

Skene

Umeå

Uppsala

Varberg

Lausanne

Lugano

Changhua

Hualien City

Kaohsiung City

Taichung

Taipei

Taoyuan

Yongkang District

Bangkok

Chang Mai

Khon Kaen

Nakhon Ratchasima

Pathum Thani

Sai Mai

Songkhla

Adana

Ankara

Antalya

Aydin

Erzurum

Eskişehir

Isparta

Istanbul

Izmir

Konya

Sivas

Cherkasy

Chernihiv

Dnipropetrovsk

Donetsk

Ivano-Frankivsh

Ivano-Frankivsk

Kharkiv

Kherson

Kyiv

Luhansk

Lutsk

Lviv

Mykolayiv

Odesa

Poltava

Uzhhorod

Vinnytsia

Zaporizhzhya

Birmingham

Blackpool

Bournemouth

Bradford

Cambridge

Chesterfield

Coventry

Devon

Dundee

East Horsley

East Sussex

Edinburgh

Essex

Glasgow

Harrow

Leicester

Liverpool

London

Middlesbrough

Orpington

Peterborough

Portadown

Sheffield

Stirling

Stockport

Surrey

Sutton Coldfield

Swindon

Warwickshire

Wolverhampton

York

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The TIMI Study Group

OTHER

lead

Daiichi Sankyo

INDUSTRY