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)

This study has been completed.
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00781391
First received: October 28, 2008
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Atrial Fibrillation
Embolism
Drug: warfarin tablets
Drug: Edoxaban tablets (high dose regimen)
Drug: Edoxaban tablets (low dose regimen)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The primary objective is to compare Edoxaban to warfarin with regard to the composite primary endpoint of stroke and systemic embolic events. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare Edoxaban to warfarin with regard to the composite clinical outcome of stroke, SEE, and all-cause mortality, as well as each component separately. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • To compare Edoxaban to warfarin with regard to major bleeding as well as major plus clinically relevant non-major bleeding [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • To compare Edoxaban to warfarin with regard to the composite clinical outcome of stroke, SEE, and CV mortality, as well as each component separately [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare Edoxaban to warfarin with regard to MACE, defined for this Phase 3 study as a composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding, as well as each component separately [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 21105
Study Start Date: November 2008
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Warfarin tablets plus placebo Edoxaban tablets
Drug: warfarin tablets
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
Experimental: 2
Edoxaban tablets plus warfarin placebo tablets
Drug: Edoxaban tablets (high dose regimen)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Experimental: 3
Edoxaban tablets plus warfarin placebo tablets
Drug: Edoxaban tablets (low dose regimen)
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781391

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Locations
United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
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Gilbert, Arizona, United States
Glendale, Arizona, United States
Lake Havasu City, Arizona, United States
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Australia
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Belgium
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Recife, Brazil
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Rio de Janeiro, Brazil
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Dimitrovgrad, Bulgaria
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Plovdiv, Bulgaria
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Calgary, Alberta, Canada
Canada, British Columbia
Campbell River, British Columbia, Canada
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Kamloops, British Columbia, Canada
Kelowna, British Columbia, Canada
New Westminster, British Columbia, Canada
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Saint John, New Brunswick, Canada
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Bridgewater, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Finland
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France
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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
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
Guadalajara, Jalisco, Mexico
Xalapa, Veracruz, Mexico
Aguascalientes, Mexico
Chihuahua, Mexico
Distrito Federal, Mexico
Durango, Mexico
Monterrey, Mexico
San Luis Potosi, Mexico
Yucatan, 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
Lower Hutt, Wellington, New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Dunedin, New Zealand
Hamilton, New Zealand
Nelson, New Zealand
Tauranga, 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
Ostrow, Mazowiecka, 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
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
Sponsors and Collaborators
Daiichi Sankyo Inc.
The TIMI Study Group
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00781391     History of Changes
Other Study ID Numbers: DU176b-C-U301
Study First Received: October 28, 2008
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Systemic embolic events

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014