Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48)

February 8, 2019 updated by: Daiichi Sankyo, Inc.

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
      • Formosa, Argentina
      • Godoy Cruz, Argentina
      • Jujuy, Argentina
      • Mar del Plata, Argentina
      • Mendoza, Argentina
      • Paraguay, Argentina
      • Provincia De Chaco, Argentina
      • Provincia De Rio Negro, Argentina
      • Provincia De Salta, Argentina
      • San Luis, Argentina
      • Santa Fe, Argentina
      • Sante Fe, Argentina
      • Tucuman, Argentina
  • Australia
      • Ashford, Australia
      • Camperdown, Australia
      • Elizabeth Vale, Australia
      • Joondalup, Australia
      • Melbourne, Australia
      • Parkville, Australia
      • Perth, Australia
    • New South Wales
      • Broken Hill, New South Wales, Australia
      • East Gosford, New South Wales, Australia
    • Queensland
      • Carina Heights, Queensland, Australia
      • Milton, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Frankston, Victoria, Australia
  • Belgium
      • Antwerpen, Belgium
      • Arlon, Belgium
      • Brugge, Belgium
      • Bruxelles, Belgium
      • Genk, Belgium
      • Hasselt, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Mechelen, Belgium
      • Merksem, Belgium
      • Moerkerke, Belgium
      • Montegnee, Belgium
      • Mousron, Belgium
      • Torhout, Belgium
      • Veurne, Belgium
      • Wetteren, Belgium
  • Brazil
      • Belo Horizonte, Brazil
      • Blumenau, Brazil
      • Brasilia, Brazil
      • Campina Grande do Sul, Brazil
      • Campinas, Brazil
      • Caxias do Sul, Brazil
      • Curitiba, Brazil
      • Goiania, Brazil
      • Lajeados, Brazil
      • Maceio, Brazil
      • Marilia, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Ribeirao Preto, Brazil
      • Rio de Janeiro, Brazil
      • Salvador, Brazil
      • Santo Andre, Brazil
      • Sao Jose, Brazil
      • Sao Paulo, Brazil
      • Uberlandia, Brazil
  • Bulgaria
      • Burgas, Bulgaria
      • Dimitrovgrad, Bulgaria
      • Haskovo, Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Ruse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
      • Mount Pearl, Canada
      • Quebec, Canada
      • St. John's, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Campbell River, British Columbia, Canada
      • Chilliwack, British Columbia, Canada
      • Coquitlam, British Columbia, Canada
      • Kamloops, British Columbia, Canada
      • Kelowna, British Columbia, Canada
      • New Westminster, British Columbia, Canada
      • Penticton, British Columbia, Canada
      • Quesnel, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada
      • Halifax, Nova Scotia, Canada
      • Liverpool, Nova Scotia, Canada
    • Ontario
      • Ajax, Ontario, Canada
      • Beamsville, Ontario, Canada
      • Brampton, Ontario, Canada
      • Corunna, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Kitchener, Ontario, Canada
      • Listowel, Ontario, Canada
      • London, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Richmond Hill, Ontario, Canada
      • Sarnia, Ontario, Canada
      • Scarborough, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Longueuil, Quebec, Canada
      • Montreal, Quebec, Canada
      • Quebec City, Quebec, Canada
      • Saint Georges De Beauce, Quebec, Canada
      • Saint-Lambert, Quebec, Canada
      • St-Charles-Borromee, Quebec, Canada
      • St.-Jerome, Quebec, Canada
      • Terrebonne, Quebec, Canada
      • Trois-Rivieres, Quebec, Canada
      • Westmount, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Chile
      • Iquique, Chile
      • La Serena, Chile
      • Osorno, Chile
      • Puerto Montt, Chile
      • Rancagua, Chile
      • Santiago, Chile
      • Talcahuano, Chile
      • Temuco, Chile
      • Victoria, Chile
      • Vina del Mar, Chile
  • China
      • Baotou, China
      • Beijing, China
      • Changchun, China
      • Changsha, China
      • Chendu City, China
      • Chongqing, China
      • Guangxi, China
      • Guangzhou, China
      • Hainan Province, China
      • Hangzhou, China
      • Harbin, China
      • Jinzhou, China
      • Lanzhou, China
      • Liaoning Province, China
      • Nanchang, China
      • Shaanxi Province, China
      • Shanghai, China
      • Shenyang, China
      • Shijiazhuang City, China
      • Tianjin, China
      • Wenzhou, China
      • Wuhan, China
  • Colombia
      • Antioquia, Colombia
      • Armenia, Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bucaramanga, Colombia
      • Cartagena, Colombia
      • Envigado, Colombia
      • Manizales, Colombia
      • Medellin, Colombia
  • Croatia
      • Dubrovnik, Croatia
      • Karlovac, Croatia
      • Koprivnica, Croatia
      • Krapinski Toplice, Croatia
      • Osijek, Croatia
      • Rijeka, Croatia
      • Slavonski Brod, Croatia
      • Split, Croatia
      • Varazdin, Croatia
      • Zadar, Croatia
      • Zagreb, Croatia
  • Czechia
      • Benatky nad Jizerou, Czechia
      • Benesov, Czechia
      • Bilovec, Czechia
      • Brno, Czechia
      • Brno-Lesna, Czechia
      • Cesky Krumlov, Czechia
      • Chrudim, Czechia
      • Havlickux Brod, Czechia
      • Hradec Kralove, Czechia
      • Hranice, Czechia
      • Jindrichuv Hradec, Czechia
      • Kolin, Czechia
      • Kromeriz, Czechia
      • Marianske Lazne, Czechia
      • Mlada Boleslav, Czechia
      • Nachod, Czechia
      • Ostrava, Czechia
      • Ostrava-Trebovice, Czechia
      • Pardubice, Czechia
      • Plzen, Czechia
      • Praha, Czechia
      • Pribram, Czechia
      • Revnice, Czechia
      • Semily, Czechia
      • Slany, Czechia
      • Teplice, Czechia
      • Trutnov, Czechia
      • Usti nad Labem, Czechia
  • Denmark
      • Aarhus N, Denmark
      • Esbjerg, Denmark
      • Frederiksberg, Denmark
      • Glostrup, Denmark
      • Hellerup, Denmark
      • Holbaek, Denmark
      • Horsens, Denmark
      • Kobenhaven, Denmark
      • Kobenhavn, Denmark
  • Estonia
      • Parnu, Estonia
      • Tallin, Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
    • Harjumaa
      • Haabneeme, Harjumaa, Estonia
    • Tartu
      • Puusepa, Tartu, Estonia
  • Finland
      • Jyvaskyla, Finland
      • Kuopio, Finland
      • Lappeenranta, Finland
      • Oulu, Finland
      • Seinajoki, Finland
      • Tampere, Finland
  • France
      • Abbeville, France
      • Amiens Cedex, France
      • Brest, France
      • Cambrai, France
      • Clamart, France
      • La Roche sur Yon, France
      • Lille, France
      • Lyon Cedex, France
      • Massy, France
      • Nantes, France
      • Paris, France
      • Pau, France
      • Pessac, France
      • Poitiers, France
      • Tours Cedex, France
      • Valenciennes, France
  • Germany
      • Altenburg, Germany
      • Aschaffenburg, Germany
      • Augsburg, Germany
      • Bad Nauheim, Germany
      • Berlin, Germany
      • Bochum, Germany
      • Cloppenburg, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Giengen, Germany
      • Goerlitz, Germany
      • Grossheirath, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Heilbronn, Germany
      • Homburg, Germany
      • Ingelheim, Germany
      • Kallstadt, Germany
      • Kassel, Germany
      • Kiel-Kronshagen, Germany
      • Koeln, Germany
      • Leipzig, Germany
      • Ludwigshafen, Germany
      • Luebeck, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Mannheim, Germany
      • Markkleeberg, Germany
      • Muenchen, Germany
      • Nienburg, Germany
      • Northeinm, Germany
      • Offenbach-beiber, Germany
      • Potsdam, Germany
      • Ruedersdorf, Germany
      • Siegen, Germany
      • Stuhr, Germany
      • Ulm, Germany
      • Unterschneidheim, Germany
      • Wardenburg, Germany
      • Wermsdorf, Germany
      • Weyhe, Germany
      • Witten, Germany
      • Woerishofen, Germany
      • Wuppertal, Germany
  • Greece
      • Athens, Greece
      • Larissa, Greece
      • Rhodes, Greece
      • Rio-Patras, Greece
      • Thessaloniki, Greece
      • Trikala, Greece
      • Voula, Greece
  • Guatemala
      • Ciudad, Guatemala
      • Clinica, Guatemala
      • Edificio Multimedica, Guatemala
      • Nivel, Guatemala
      • Oficina, Guatemala
      • Quetzaltenango, Guatemala
      • Zacapa, Guatemala
  • Hungary
      • Ajka, Hungary
      • Baja, Hungary
      • Bekescsaba, Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Hodmezovasarhely, Hungary
      • Kecskemet, Hungary
      • Keeskemet, Hungary
      • Kistarcsa, Hungary
      • Komarom, Hungary
      • Mako, Hungary
      • Nagykanizsa, Hungary
      • Nyiregyhaza, Hungary
      • Pecs, Hungary
      • Sopron, Hungary
      • Szekszard, Hungary
      • Szombathely, Hungary
      • Zalaegerszeg, Hungary
  • India
      • Ahmedabad, India
      • Anddhra Pradesh, India
      • Andhra Pradesh, India
      • Aurangabad, India
      • Bangalore, India
      • Bikaner, India
      • Chennai, India
      • Coimbatore, India
      • Delhi, India
      • Gujrat, India
      • Indore, India
      • Jaipur, India
      • Karnataka, India
      • Kerala, India
      • Kolkata, India
      • Ludhiana, India
      • Madhya Pradesh, India
      • Maharashtra, India
      • Mangalore, India
      • Mumbai, India
      • Nagpur, India
      • Nashik, India
      • New Delhi, India
      • Pune, India
      • Puni, India
      • Punjab, India
      • Rajasthan, India
      • Ramnagar, India
      • Shimoga, India
      • Surat, India
      • Trivandrum, India
      • Vadodara, India
    • AP
      • Hyderabad, AP, India
      • Vijayawada, AP, India
    • Kerala
      • Angamaly, Kerala, India
      • Kochi, Kerala, India
      • Thrissur, Kerala, India
  • Israel
      • Afula, Israel
      • Beer-Sheva, Israel
      • Dimona, Israel
      • Givatayim, Israel
      • Hadera, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Nahariya, Israel
      • Nazareth, Israel
      • Petach Tikva, Israel
      • Petah-Tikva, Israel
      • Poriya, Israel
      • Raanana, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Tel Hashomer, Israel
      • Zerifin, Israel
  • Italy
      • Bologna, Italy
      • Brescia, Italy
      • Cantania, Italy
      • Casarano, Italy
      • Caserta, Italy
      • Chieti, Italy
      • Cremona, Italy
      • Genova, Italy
      • Grosseto, Italy
      • Legnano, Italy
      • Manerbio, Italy
      • Milano, Italy
      • Monserrato, Italy
      • Napoli, Italy
      • Novara, Italy
      • Ostia, Italy
      • Pavia, Italy
      • Pisa, Italy
      • Pozzuoli, Italy
      • Roma, Italy
      • Santa Maria Capua Vetere, Italy
      • Sassari, Italy
      • Seriate, Italy
      • Siena, Italy
      • Trieste, Italy
      • Venezia Mestre, Italy
  • Japan
      • Aichi, Japan
      • Aomori, Japan
      • Chiaki, Japan
      • Chiba, Japan
      • Ehime, Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Gifu, Japan
      • Gunma, Japan
      • Hiroshima, Japan
      • Hokkai-do, Japan
      • Hokkaido, Japan
      • Hyogo, Japan
      • Ibaraki, Japan
      • Isesaki-shi, Japan
      • Ishikawa, Japan
      • Iwate, Japan
      • Kagawa, Japan
      • Kanagawa, Japan
      • Kumamoto, Japan
      • Kyota, Japan
      • Mie, Japan
      • Miyagi, Japan
      • Nagaoka-shi, Japan
      • Nagasaki, Japan
      • Niigata, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Shimane, Japan
      • Shizuoka, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Yamaguchi, Japan
      • Yokohama-shi, Japan
    • Kyoto
      • Kyoto-shi, Kyoto, Japan
    • Nagano
      • Lida-shi, Nagano, Japan
      • Ueda-shi, Nagano, Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Gangwon-do, Korea, Republic of
      • Gwangju-si, Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
      • Incheon, Korea, Republic of
      • Pusan, Korea, Republic of
      • Seoul, Korea, Republic of
  • Mexico
      • Aguascalientes, Mexico
      • Chihuahua, Mexico
      • Distrito Federal, Mexico
      • Durango, Mexico
      • Monterrey, Mexico
      • San Luis Potosi, Mexico
      • Yucatan, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Veracruz
      • Xalapa, Veracruz, Mexico
  • Netherlands
      • Almere, Netherlands
      • Amstelveen, Netherlands
      • Amsterdam, Netherlands
      • Dordrecht, Netherlands
      • Eindhoven, Netherlands
      • Ewijk, Netherlands
      • Leiderdorp, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
      • Venlo, Netherlands
      • Wildervlank, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Hamilton, New Zealand
      • Nelson, New Zealand
      • Tauranga, New Zealand
    • Wellington
      • Lower Hutt, Wellington, New Zealand
  • Norway
      • Bodo, Norway
      • Harstad, Norway
      • Haugesund, Norway
      • Oslo, Norway
      • Rud, Norway
  • Peru
      • Arequipa, Peru
      • Callao, Peru
      • Lima, Peru
  • Philippines
      • Cebu, Philippines
      • Cebu City, Philippines
      • Davao City, Philippines
      • Pasig City, Philippines
      • Quezon City, Philippines
  • Poland
      • Bydgoszcz, Poland
      • Chojnice, Poland
      • Elblag, Poland
      • Elk, Poland
      • Gdansk, Poland
      • Inowroclaw, Poland
      • Jaroslaw, Poland
      • Katowice, Poland
      • Kolobrzeg, Poland
      • Komenskiego, Poland
      • Krakow, Poland
      • Kutno, Poland
      • Libiaz, Poland
      • Lodz, Poland
      • Lubartow, Poland
      • Lublin, Poland
      • Plock, Poland
      • Pomorskie, Poland
      • Pulawy, Poland
      • Ruda Slaska, Poland
      • Rzeszow, Poland
      • Skierniewice, Poland
      • Sopot, Poland
      • Sucharskiego, Poland
      • Szczecin, Poland
      • Tarnow, Poland
      • Torun, Poland
      • Warszawa, Poland
      • Warzawa, Poland
      • Wroclaw, Poland
    • Mazowiecka
      • Ostrow, Mazowiecka, Poland
  • Portugal
      • Amadora, Portugal
      • Aveiro, Portugal
      • Braga, Portugal
      • Coimbra, Portugal
      • Leiria, Portugal
      • Lisboa, Portugal
      • Lisbon, Portugal
      • Ponta Delgada, Portugal
      • Setubal, Portugal
      • Viseu, Portugal
  • Romania
      • Bacau, Romania
      • Braila, Romania
      • Brasov, Romania
      • Buccuresti, Romania
      • Bucuresti, Romania
      • Buzau, Romania
      • Covasna, Romania
      • Dambovita, Romania
      • Iasi, Romania
      • Judetul Maramures, Romania
      • Judetul Mures, Romania
      • Judetul Suceava, Romania
      • Judetul Vrancea, Romania
      • Oradea, Romania
      • Timisoara, Romania
  • Russian Federation
      • Barnaul, Russian Federation
      • Chelyabinsk, Russian Federation
      • Kemerovo, Russian Federation
      • Krasnoyarsk, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Omsk, Russian Federation
      • Orenburg, Russian Federation
      • Perm, Russian Federation
      • Ryazan, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • St-Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Tula, Russian Federation
      • Tyumen, Russian Federation
      • Volgograd, Russian Federation
      • Voronezh, Russian Federation
      • Yaroslavl, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Nis, Serbia
      • Niska Banja, Serbia
      • Sremska Kamenica, Serbia
      • Zemun, Serbia
      • Zmaj Jovina, Serbia
  • Slovakia
      • Bardejov, Slovakia
      • Bratislava, Slovakia
      • Dolny Kubin, Slovakia
      • Galanta, Slovakia
      • Kosice, Slovakia
      • Levice, Slovakia
      • Lucenec, Slovakia
      • Nitra, Slovakia
      • Nove Zamky, Slovakia
      • Presov, Slovakia
      • Rimavska Sobota, Slovakia
  • South Africa
      • Alberton, South Africa
      • Benoni, South Africa
      • Bloemfontein, South Africa
      • Cape Town, South Africa
      • Diepkloof, South Africa
      • Durban, South Africa
      • Lyttelton, South Africa
      • Parktown West, South Africa
      • Port Elizabeth, South Africa
      • Potchefstroom, South Africa
      • Pretoria, South Africa
      • Somerset West, South Africa
      • Worcester, South Africa
  • Spain
      • Alcoy, Spain
      • Almeria, Spain
      • Barcelona, Spain
      • Bilbao, Spain
      • De La Castellana, Spain
      • Donostia-San Sebastian, Spain
      • Figueras, Spain
      • Jaen, Spain
      • La Coruna, Spain
      • Lleida, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Santiago De Compostela, Spain
      • Sevilla, Spain
      • Vigo, Spain
      • Vitoria, Spain
  • Sweden
      • Alingsas, Sweden
      • Enkoping, Sweden
      • Goteborg, Sweden
      • Halmstad, Sweden
      • Karlshamn, Sweden
      • Koping, Sweden
      • Lindesberg, Sweden
      • Lulea, Sweden
      • Lund, Sweden
      • Malmo, Sweden
      • Molndal, Sweden
      • Mora, Sweden
      • Orebro, Sweden
      • Skene, Sweden
      • Umea, Sweden
      • Uppsala, Sweden
      • Varberg, Sweden
  • Switzerland
      • Lausanne, Switzerland
      • Lugano, Switzerland
  • Taiwan
      • Changhua City, Taiwan
      • Hualien City, Taiwan
      • Kaohsiung City, Taiwan
      • Taichung City, Taiwan
      • Taipei, Taiwan
      • Taipei City, Taiwan
      • Taoyuan County, Taiwan
      • Yongkang City, Taiwan
  • Thailand
      • Bangkok, Thailand
      • Chang Mai, Thailand
      • Khon Kaen, Thailand
      • Nakhon Ratchasima, Thailand
      • Pathumthani, Thailand
      • Sai Mai, Thailand
      • Songkhla, Thailand
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Antalya, Turkey
      • Aydin, Turkey
      • Erzurum, Turkey
      • Eskisehir, Turkey
      • Isparta, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Konya, Turkey
      • Sivas, Turkey
  • Ukraine
      • Cherkasy, Ukraine
      • Chernigiv, Ukraine
      • Dnipropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankivsh, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kherson, Ukraine
      • Kyiv, Ukraine
      • Lugansk, Ukraine
      • Lutsk, Ukraine
      • Lviv, Ukraine
      • Mykolayiv, Ukraine
      • Odesa, Ukraine
      • Poltava, Ukraine
      • Uzhgorod, Ukraine
      • Vinnytsya, Ukraine
      • Zaporizhzhya, Ukraine
  • United Kingdom
      • Birmingham, United Kingdom
      • Blackpool, United Kingdom
      • Bournemouth, United Kingdom
      • Bradford, United Kingdom
      • Cambridge, United Kingdom
      • Chesterfield, United Kingdom
      • Coventry, United Kingdom
      • Devon, United Kingdom
      • Dundee, United Kingdom
      • East Horsley, United Kingdom
      • East Sussex, United Kingdom
      • Edinburgh, United Kingdom
      • Essex, United Kingdom
      • Glasgow, United Kingdom
      • Harrow, United Kingdom
      • Leicester, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Middlesbrough, United Kingdom
      • Orpington, United Kingdom
      • Peterborough, United Kingdom
      • Portadown, United Kingdom
      • Sheffield, United Kingdom
      • Stirling, United Kingdom
      • Stockport, United Kingdom
      • Surrey, United Kingdom
      • Sutton Coldfield, United Kingdom
      • Swindon, United Kingdom
      • Warwickshire, United Kingdom
      • Wolverhampton, United Kingdom
      • York, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Gilbert, Arizona, United States
      • Glendale, Arizona, United States
      • Lake Havasu City, Arizona, United States
      • Sierra Vista, Arizona, United States, 85635
      • Tempe, Arizona, United States, 85283
      • Tucson, Arizona, United States
    • Arkansas
      • Harrisburg, Arkansas, United States
      • Hot Springs, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Alhambra, California, United States
      • Anaheim, California, United States
      • Burbank, California, United States
      • Chula Vista, California, United States
      • Encinitas, California, United States
      • Fountain Valley, California, United States
      • Glendale, California, United States
      • Healdsburg, California, United States
      • Lakewood, California, United States
      • Long Beach, California, United States
      • Los Alamitos, California, United States
      • Los Angeles, California, United States
      • Los Banos, California, United States
      • Mather, California, United States
      • Merced, California, United States
      • Newport Beach, California, United States
      • Oceanside, California, United States
      • Pacific Palisades, California, United States
      • Palm Springs, California, United States
      • Pismo Beach, California, United States
      • Redondo Beach, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • Santa Rosa, California, United States
      • Torrance, California, United States
      • Ventura, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States, 80904
      • Denver, Colorado, United States
      • Englewood, Colorado, United States
      • Greeley, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • Guilford, Connecticut, United States
      • Hamden, Connecticut, United States
      • Manchester, Connecticut, United States
      • New Haven, Connecticut, United States
      • North Haven, Connecticut, United States
      • Shelton, Connecticut, United States
      • Stamford, Connecticut, United States
      • Trumbull, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Aventura, Florida, United States
      • Chipley, Florida, United States
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States, 32114
      • Daytona Beach, Florida, United States
      • DeBary, Florida, United States
      • Deerfield Beach, Florida, United States
      • Delray Beach, Florida, United States
      • Delray Beach, Florida, United States, 33484
      • Hialeah, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Jacksonville Beach, Florida, United States
      • Jupiter, Florida, United States
      • Leesburg, Florida, United States, 34748
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • Miami, Florida, United States, 33173
      • Naples, Florida, United States
      • Orange Park, Florida, United States
      • Orlando, Florida, United States
      • Ormond Beach, Florida, United States
      • Panama City, Florida, United States
      • Pembroke Pines, Florida, United States
      • Pensacola, Florida, United States
      • Plantation, Florida, United States
      • Port Charlotte, Florida, United States
      • Rockledge, Florida, United States
      • Saint Augustine, Florida, United States
      • Saint Petersburg, Florida, United States
      • Sarasota, Florida, United States
      • Stuart, Florida, United States
      • Tamarac, Florida, United States
      • Tampa, Florida, United States
      • The Villages, Florida, United States
      • Vero Beach, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Conyers, Georgia, United States, 30013
      • Covington, Georgia, United States
      • Cumming, Georgia, United States
      • Savannah, Georgia, United States
      • Snellville, Georgia, United States, 30039
      • Tucker, Georgia, United States
      • Watkinsville, Georgia, United States
      • Waycross, Georgia, United States
      • Woodstock, Georgia, United States, 30188
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Boise, Idaho, United States
      • Hayden Lake, Idaho, United States
    • Illinois
      • Bannockburn, Illinois, United States
      • Belleville, Illinois, United States, 82220
      • Chicago, Illinois, United States
      • Elgin, Illinois, United States
      • Joliet, Illinois, United States
      • Libertyville, Illinois, United States
      • Maywood, Illinois, United States
      • Melrose Park, Illinois, United States
      • Oak Lawn, Illinois, United States
      • Springfield, Illinois, United States
      • Winfield, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
      • Munster, Indiana, United States
    • Iowa
      • Ames, Iowa, United States
      • Council Bluffs, Iowa, United States
      • Iowa City, Iowa, United States
      • Shell Rock, Iowa, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
      • Campbellsville, Kentucky, United States
      • Elizabethtown, Kentucky, United States
      • Richmond, Kentucky, United States
    • Louisiana
      • Marrero, Louisiana, United States
      • West Monroe, Louisiana, United States, 71291
      • West Monroe, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
      • Biddeford, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bel Air, Maryland, United States
      • Bethesda, Maryland, United States
      • Lexington Park, Maryland, United States
      • Rockville, Maryland, United States
      • Salisbury, Maryland, United States
      • Towson, Maryland, United States
      • Westminster, Maryland, United States
    • Massachusetts
      • Ayer, Massachusetts, United States
      • Boston, Massachusetts, United States
      • Concord, Massachusetts, United States
      • East Bridgewater, Massachusetts, United States
      • Haverhill, Massachusetts, United States
      • Methuen, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Bay City, Michigan, United States
      • Benzonia, Michigan, United States
      • Chelsea, Michigan, United States
      • Commerce, Michigan, United States
      • Detroit, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Interlochen, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lapeer, Michigan, United States
      • Midland, Michigan, United States
      • Rochester Hills, Michigan, United States
      • Saginaw, Michigan, United States
      • Troy, Michigan, United States
      • Warren, Michigan, United States
    • Minnesota
      • Golden Valley, Minnesota, United States
      • Minneapolis, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Mississippi
      • Biloxi, Mississippi, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • Joplin, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Charles, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Kalispell, Montana, United States
    • Nebraska
      • Fremont, Nebraska, United States, 68025
      • Grand Island, Nebraska, United States
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Jersey
      • Belvidere, New Jersey, United States
      • Brick, New Jersey, United States
      • Bridgewater, New Jersey, United States
      • Browns Mills, New Jersey, United States
      • Cherry Hill, New Jersey, United States
      • Elizabeth, New Jersey, United States
      • Haddon Heights, New Jersey, United States
      • Hamilton, New Jersey, United States
      • Mine Hill, New Jersey, United States
      • Ocean City, New Jersey, United States
      • Passaic, New Jersey, United States
      • Ridgewood, New Jersey, United States
      • Somerset, New Jersey, United States
      • Toms River, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Brooklyn, New York, United States
      • Buffalo, New York, United States
      • Cortlandt Manor, New York, United States
      • Hawthorne, New York, United States
      • Jamaica, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
      • North Massapequa, New York, United States
      • Saratoga Springs, New York, United States
      • Troy, New York, United States
    • North Carolina
      • Cary, North Carolina, United States
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States, 28207
      • Greensboro, North Carolina, United States, 27408
      • Mooresville, North Carolina, United States
      • Morehead City, North Carolina, United States, 28557
      • Morganton, North Carolina, United States
      • Morganton, North Carolina, United States, 28655
      • Oxford, North Carolina, United States
      • Pinehurst, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
      • Oakes, North Dakota, United States
    • Ohio
      • Akron, Ohio, United States
      • Canal Fulton, Ohio, United States
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Cuyahoga Falls, Ohio, United States
      • Dayton, Ohio, United States
      • Fairfield, Ohio, United States
      • Marion, Ohio, United States
      • Middletown, Ohio, United States
      • Pitsburg, Ohio, United States
      • Springfield, Ohio, United States, 45505
      • Thornville, Ohio, United States
      • Toledo, Ohio, United States
      • Willoughby Hills, Ohio, United States
    • Oklahoma
      • Bartlesville, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
      • Corvallis, Oregon, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
      • Beaver, Pennsylvania, United States
      • Chester, Pennsylvania, United States
      • Clymer, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Ephrata, Pennsylvania, United States
      • Feasterville, Pennsylvania, United States
      • Fleetwood, Pennsylvania, United States, 19522
      • Greenville, Pennsylvania, United States
      • Johnstown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Lewistown, Pennsylvania, United States
      • Newport, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Pottstown, Pennsylvania, United States
      • Scranton, Pennsylvania, United States
      • Sellersville, Pennsylvania, United States
      • Somerset, Pennsylvania, United States
      • State College, Pennsylvania, United States
      • Uniontown, Pennsylvania, United States
      • Wilkes-Barre, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
      • Yardley, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Florence, South Carolina, United States
      • Greenville, South Carolina, United States
      • Greer, South Carolina, United States, 29651
      • Mount Pleasant, South Carolina, United States
      • Spartanburg, South Carolina, United States, 29302
      • Summerville, South Carolina, United States
      • Taylors, South Carolina, United States
      • Walterboro, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Columbia, Tennessee, United States
      • Jackson, Tennessee, United States
      • Johnson City, Tennessee, United States
      • Nashville, Tennessee, United States
      • Oak Ridge, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Carrollton, Texas, United States
      • Corsicana, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Georgetown, Texas, United States
      • Grapevine, Texas, United States
      • Houston, Texas, United States
      • Lubbock, Texas, United States
      • McAllen, Texas, United States
      • Odessa, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • Tomball, Texas, United States
      • Wichita Falls, Texas, United States
    • Utah
      • Provo, Utah, United States
      • West Valley City, Utah, United States, 84120
    • Virginia
      • Danville, Virginia, United States
      • Hopewell, Virginia, United States
      • Newport News, Virginia, United States
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23294
      • Springfield, Virginia, United States
      • Suffolk, Virginia, United States
      • Virginia Beach, Virginia, United States
      • Winchester, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Kirkland, Washington, United States
      • Renton, Washington, United States
      • Seattle, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
    • West Virginia
      • Clarksburg, West Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Manitowoc, Wisconsin, United States
      • Menomonee Falls, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 years of age or older; male or female.
  • Able to provide written informed consent.
  • History of documented AF within the prior 12 months
  • A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria:

  • Transient atrial fibrillation secondary to other reversible disorders
  • Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
  • Subjects with any contraindication for anticoagulant agents;
  • Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders

  • Females of childbearing potential including the following:

    • Females with a history of tubal-ligation
    • Females less than 2 years post-menopausal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Warfarin/placebo edoxaban
Warfarin tablets plus placebo Edoxaban tablets
Drug: warfarin tablets
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
Drug: placebo edoxaban
placebo edoxaban
Experimental: high dose edoxaban/placebo warfarin
Edoxaban tablets (60mg) plus warfarin placebo tablets
Drug: Edoxaban tablets (high dose regimen-60mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Drug: placebo warfarin
placebo warfarin
Experimental: low dose edoxaban/placebo warfarin
Edoxaban tablets (30mg) plus warfarin placebo tablets
Drug: placebo warfarin
placebo warfarin
Drug: Edoxaban tablets (low dose regimen-30mg)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Time Frame: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Time Frame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Time Frame: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
Time Frame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
Time Frame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
Time Frame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
Time Frame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
Time Frame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Adjudicated Bleeding Events
Time Frame: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.

Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements.
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Collaborators

The TIMI Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DU176b-C-U301

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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