AzTrials
AzTrials

StrokePhase 3EngageAFTIMI48NCT00781391

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

A Phase 3 study testing warfarin tablets, Edoxaban tablets (high dose regimen-60mg) and Edoxaban tablets (low dose regimen-30mg) in people with Stroke and Atrial Fibrillation, run by Daiichi Sankyo at 1,009 sites in 46 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

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Stroke, Atrial Fibrillation, Embolism
What is being tested?
warfarin tablets, Edoxaban tablets (high dose regimen-60mg) and Edoxaban tablets (low dose regimen-30mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21,105 participants
Where
1,009 sitesin 46 countries
Study dates
Nov 2008to May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1,009 sites in 46 countries.

993 sites in 46 countries

United States300 sites

  • Study site

    Akron, Ohio

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alhambra, California

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Ames, Iowa

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Arlington, Texas

  • Study site

    Athens, Georgia

  • Study site

    Atlanta, Georgia

  • Study site

    Auburn, Maine

  • Study site

    Aurora, Colorado

  • Study site

    Austin, Texas

  • Study site

    Aventura, Florida

  • Study site

    Ayer, Massachusetts

  • Study site

    Baltimore, Maryland

  • Study site

    Bannockburn, Illinois

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bay City, Michigan

  • Study site

    Beaver, Pennsylvania

  • Study site

    Bel Air, Maryland

  • Study site

    Belleville, Illinois, 82220

  • Study site

    Bellevue, Washington

  • Study site

    Belvidere, New Jersey

  • Study site

    Bend, Oregon

  • Study site

    Benzonia, Michigan

  • Study site

    Bethesda, Maryland

  • Study site

    Biddeford, Maine

  • Study site

    Biloxi, Mississippi

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomington, Indiana

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Bowling Green, Kentucky

  • Study site

    Brick, New Jersey

  • Study site

    Bridgeport, Connecticut

  • Study site

    Bridgewater, New Jersey

  • Study site

    Brooklyn, New York

  • Study site

    Browns Mills, New Jersey

  • Study site

    Buffalo, New York

  • Study site

    Burbank, California

  • Study site

    Campbellsville, Kentucky

  • Study site

    Canal Fulton, Ohio

  • Study site

    Canton, Ohio

  • Study site

    Carrollton, Texas

  • Study site

    Cary, North Carolina

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Chelsea, Michigan

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Chester, Pennsylvania

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago, Illinois

  • Study site

    Chipley, Florida

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksburg, West Virginia

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Clymer, Pennsylvania

  • Study site

    Colorado Springs, Colorado, 80904

  • Study site

    Columbia, South Carolina

  • Study site

    Columbia, Tennessee

  • Study site

    Columbus, Ohio

  • Study site

    Commerce, Michigan

  • Study site

    Concord, Massachusetts

  • Study site

    Conyers, Georgia, 30013

  • Study site

    Corsicana, Texas

  • Study site

    Cortlandt Manor, New York

  • Study site

    Corvallis, Oregon

  • Study site

    Council Bluffs, Iowa

  • Study site

    Covington, Georgia

  • Study site

    Cumming, Georgia

  • Study site

    Cuyahoga Falls, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Danville, Pennsylvania

  • Study site

    Danville, Virginia

  • Study site

    Dayton, Ohio

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Daytona Beach, Florida

  • Study site

    DeBary, Florida

  • Study site

    Deerfield Beach, Florida

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Delray Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Doylestown, Pennsylvania

  • Study site

    East Bridgewater, Massachusetts

  • Study site

    Elgin, Illinois

  • Study site

    Elizabeth, New Jersey

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Encinitas, California

  • Study site

    Englewood, Colorado

  • Study site

    Ephrata, Pennsylvania

  • Study site

    Fairfield, Ohio

  • Study site

    Fargo, North Dakota

  • Study site

    Feasterville, Pennsylvania

  • Study site

    Fleetwood, Pennsylvania, 19522

  • Study site

    Florence, South Carolina

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Fremont, Nebraska, 68025

  • Study site

    Georgetown, Texas

  • Study site

    Gilbert, Arizona

  • Study site

    Glendale, Arizona

  • Study site

    Glendale, California

  • Study site

    Golden Valley, Minnesota

  • Study site

    Grand Island, Nebraska

  • Study site

    Grand Rapids, Michigan

  • Study site

    Grapevine, Texas

  • Study site

    Greeley, Colorado

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Greenville, Pennsylvania

  • Study site

    Greenville, South Carolina

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Guilford, Connecticut

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hamden, Connecticut

  • Study site

    Hamilton, New Jersey

  • Study site

    Harrisburg, Arkansas

  • Study site

    Haverhill, Massachusetts

  • Study site

    Hawthorne, New York

  • Study site

    Hayden Lake, Idaho

  • Study site

    Healdsburg, California

  • Study site

    Henderson, Nevada

  • Study site

    Hialeah, Florida

  • Study site

    Hollywood, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Hopewell, Virginia

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Interlochen, Michigan

  • Study site

    Iowa City, Iowa

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jacksonville Beach, Florida

  • Study site

    Jamaica, New York

  • Study site

    Johnson City, Tennessee

  • Study site

    Johnstown, Pennsylvania

  • Study site

    Joliet, Illinois

  • Study site

    Joplin, Missouri

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kalispell, Montana

  • Study site

    Kansas City, Missouri

  • Study site

    Kirkland, Washington

  • Study site

    Lake Havasu City, Arizona

  • Study site

    Lakewood, California

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lapeer, Michigan

  • Study site

    Leesburg, Florida, 34748

  • Study site

    Lewistown, Pennsylvania

  • Study site

    Lexington Park, Maryland

  • Study site

    Libertyville, Illinois

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Alamitos, California

  • Study site

    Los Angeles, California

  • Study site

    Los Banos, California

  • Study site

    Lubbock, Texas

  • Study site

    Madison, Wisconsin

  • Study site

    Manchester, Connecticut

  • Study site

    Manitowoc, Wisconsin

  • Study site

    Marion, Ohio

  • Study site

    Marrero, Louisiana

  • Study site

    Mather, California

  • Study site

    Maywood, Illinois

  • Study site

    McAllen, Texas

  • Study site

    Melbourne, Florida

  • Study site

    Melrose Park, Illinois

  • Study site

    Menomonee Falls, Wisconsin

  • Study site

    Merced, California

  • Study site

    Methuen, Massachusetts

  • Study site

    Miami, Florida, 33173

  • Study site

    Miami, Florida

  • Study site

    Middletown, Ohio

  • Study site

    Midland, Michigan

  • Study site

    Mine Hill, New Jersey

  • Study site

    Mineola, New York

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    Mooresville, North Carolina

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Morganton, North Carolina

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Munster, Indiana

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Newport, Pennsylvania

  • Study site

    Newport Beach, California

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Haven, Connecticut

  • Study site

    North Massapequa, New York

  • Study site

    Oak Lawn, Illinois

  • Study site

    Oak Ridge, Tennessee

  • Study site

    Oakes, North Dakota

  • Study site

    Ocean City, New Jersey

  • Study site

    Oceanside, California

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange Park, Florida

  • Study site

    Orlando, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Oxford, North Carolina

  • Study site

    Pacific Palisades, California

  • Study site

    Palm Springs, California

  • Study site

    Panama City, Florida

  • Study site

    Passaic, New Jersey

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Pismo Beach, California

  • Study site

    Pitsburg, Ohio

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Plantation, Florida

  • Study site

    Port Charlotte, Florida

  • Study site

    Pottstown, Pennsylvania

  • Study site

    Providence, Rhode Island

  • Study site

    Provo, Utah

  • Study site

    Rapid City, South Dakota

  • Study site

    Redondo Beach, California

  • Study site

    Renton, Washington

  • Study site

    Richmond, Kentucky

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Ridgewood, New Jersey

  • Study site

    Rochester Hills, Michigan

  • Study site

    Rockledge, Florida

  • Study site

    Rockville, Maryland

  • Study site

    Sacramento, California

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Augustine, Florida

  • Study site

    Saint Charles, Missouri

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salisbury, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Rosa, California

  • Study site

    Sarasota, Florida

  • Study site

    Saratoga Springs, New York

  • Study site

    Savannah, Georgia

  • Study site

    Scranton, Pennsylvania

  • Study site

    Seattle, Washington

  • Study site

    Sellersville, Pennsylvania

  • Study site

    Shell Rock, Iowa

  • Study site

    Shelton, Connecticut

  • Study site

    Sierra Vista, Arizona, 85635

  • Study site

    Snellville, Georgia, 30039

  • Study site

    Somerset, New Jersey

  • Study site

    Somerset, Pennsylvania

  • Study site

    Spartanburg, South Carolina, 29302

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Ohio, 45505

  • Study site

    Springfield, Virginia

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stamford, Connecticut

  • Study site

    State College, Pennsylvania

  • Study site

    Statesville, North Carolina

  • Study site

    Stuart, Florida

  • Study site

    Suffolk, Virginia

  • Study site

    Summerville, South Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Tamarac, Florida

  • Study site

    Tampa, Florida

  • Study site

    Taylors, South Carolina

  • Study site

    Tempe, Arizona, 85283

  • Study site

    The Villages, Florida

  • Study site

    Thornville, Ohio

  • Study site

    Toledo, Ohio

  • Study site

    Tomball, Texas

  • Study site

    Toms River, New Jersey

  • Study site

    Torrance, California

  • Study site

    Towson, Maryland

  • Study site

    Troy, Michigan

  • Study site

    Troy, New York

  • Study site

    Trumbull, Connecticut

  • Study site

    Tucker, Georgia

  • Study site

    Tucson, Arizona

  • Study site

    Uniontown, Pennsylvania

  • Study site

    Ventura, California

  • Study site

    Vero Beach, Florida

  • Study site

    Virginia Beach, Virginia

  • Study site

    Walterboro, South Carolina

  • Study site

    Warren, Michigan

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Watkinsville, Georgia

  • Study site

    Waycross, Georgia

Other trials in United States

Germany46 sites

  • Study site

    Altenburg

  • Study site

    Aschaffenburg

  • Study site

    Augsburg

  • Study site

    Bad Nauheim

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Cloppenburg

  • Study site

    Cologne

  • Study site

    Dortmund

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Giengen an der Brenz

  • Study site

    Görlitz

  • Study site

    Großheirath

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Heilbronn

  • Study site

    Homburg

  • Study site

    Ingelheim

  • Study site

    Kallstadt

  • Study site

    Kassel

  • Study site

    Kiel-Kronshagen

  • Study site

    Leipzig

  • Study site

    Lübeck

  • Study site

    Ludwigshafen

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Mannheim

  • Study site

    Markkleeberg

  • Study site

    München

  • Study site

    Nienburg

  • Study site

    Northeinm

  • Study site

    Offenbach-beiber

  • Study site

    Potsdam

  • Study site

    Rüdersdorf

  • Study site

    Siegen

  • Study site

    Stuhr

  • Study site

    Ulm

  • Study site

    Unterschneidheim

  • Study site

    Wardenburg

  • Study site

    Wermsdorf

  • Study site

    Weyhe

  • Study site

    Witten

  • Study site

    Woerishofen

  • Study site

    Wuppertal

Other trials in Germany

Canada43 sites

  • Study site

    Ajax, Ontario

  • Study site

    Beamsville, Ontario

  • Study site

    Brampton, Ontario

  • Study site

    Bridgewater, Nova Scotia

  • Study site

    Calgary, Alberta

  • Study site

    Campbell River, British Columbia

  • Study site

    Chilliwack, British Columbia

  • Study site

    Coquitlam, British Columbia

  • Study site

    Corunna, Ontario

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Greenfield Park, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kamloops, British Columbia

  • Study site

    Kelowna, British Columbia

  • Study site

    Kitchener, Ontario

  • Study site

    Listowel, Ontario

  • Study site

    Liverpool, Nova Scotia

  • Study site

    London, Ontario

  • Study site

    Longueuil, Quebec

  • Study site

    Montreal, Quebec

  • Study site

    Mount Pearl

  • Study site

    New Westminster, British Columbia

  • Study site

    Oshawa, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Penticton, British Columbia

  • Study site

    Québec, Quebec

  • Study site

    Quesnel, British Columbia

  • Study site

    Richmond Hill, Ontario

  • Study site

    Saint Georges de Beauce, Quebec

  • Study site

    Saint John, New Brunswick

  • Study site

    Saint-Charles-Borromée, Quebec

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Saint-Lambert, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Scarborough Village, Ontario

  • Study site

    St. John's

  • Study site

    Terrebonne, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Trois-Rivières, Quebec

  • Study site

    Victoria, British Columbia

  • Study site

    Westmount, Quebec

Other trials in Canada

Japan39 sites

  • Study site

    Aichi

  • Study site

    Aomori

  • Study site

    Chiaki

  • Study site

    Chiba

  • Study site

    Ehime

  • Study site

    Fukuoka

  • Study site

    Fukushima

  • Study site

    Gifu

  • Study site

    Gunma

  • Study site

    Hiroshima

  • Study site

    Hokkai-do

  • Study site

    Hokkaido

  • Study site

    Hyōgo

  • Study site

    Ibaraki

  • Study site

    Isesaki-shi

  • Study site

    Ishikawa

  • Study site

    Kagawa

  • Study site

    Kanagawa

  • Study site

    Kumamoto

  • Study site

    Kyoda

  • Study site

    Kyoto, Kyoto

  • Study site

    Lida-shi, Nagano

  • Study site

    Mie

  • Study site

    Minato-ku, Tokyo

  • Study site

    Miyagi

  • Study site

    Nagaoka-shi

  • Study site

    Nagasaki

  • Study site

    Niigata

  • Study site

    Numakunai

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Saitama

  • Study site

    Shimane

  • Study site

    Shizuoka

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Ueda-shi, Nagano

  • Study site

    Yamaguchi

  • Study site

    Yokohama

Other trials in Japan

India37 sites

  • Study site

    Ahmedabad

  • Study site

    Anddhra Pradesh

  • Study site

    Andhra Pradesh

  • Study site

    Angamaly, Kerala

  • Study site

    Bangalore

  • Study site

    Bikaner

  • Study site

    Chennai

  • Study site

    Chhatrapati Sambhajinagar

  • Study site

    Coimbatore

  • Study site

    Delhi

  • Study site

    Gujrāt

  • Study site

    Hyderabad, Andhra Pradesh

  • Study site

    Indore

  • Study site

    Jaipur

  • Study site

    Karnataka

  • Study site

    Kerala

  • Study site

    Kochi, Kerala

  • Study site

    Kolkata

  • Study site

    Ludhiana

  • Study site

    Madhya Pradesh

  • Study site

    Maharashtra

  • Study site

    Mangalore

  • Study site

    Mumbai

  • Study site

    Nagpur

  • Study site

    Nashik

  • Study site

    New Delhi

  • Study site

    Pune

  • Study site

    Pūni

  • Study site

    Punjab

  • Study site

    Rajasthan

  • Study site

    Ramnagar

  • Study site

    Shimoga

  • Study site

    Surat

  • Study site

    Thrissur, Kerala

  • Study site

    Trivandrum

  • Study site

    Vadodara

  • Study site

    Vijayawada, Andhra Pradesh

Other trials in India

Poland31 sites

  • Study site

    Bydgoszcz

  • Study site

    Chojnice

  • Study site

    Elblag

  • Study site

    Ełk

  • Study site

    Gdansk

  • Study site

    Inowrocław

  • Study site

    Jarosław

  • Study site

    Katowice

  • Study site

    Kołobrzeg

  • Study site

    Komenskiego

  • Study site

    Krakow

  • Study site

    Kutno

  • Study site

    Libiąż

  • Study site

    Lodz

  • Study site

    Lubartów

  • Study site

    Lublin

  • Study site

    Ostrów, Mazowiecka

  • Study site

    Płock

  • Study site

    Pomorskie

  • Study site

    Puławy

  • Study site

    Ruda Śląska

  • Study site

    Rzeszów

  • Study site

    Skierniewice

  • Study site

    Sopot

  • Study site

    Sucharskiego

  • Study site

    Szczecin

  • Study site

    Tarnów

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Warzawa

  • Study site

    Wroclaw

Other trials in Poland

United Kingdom31 sites

  • Study site

    Birmingham

  • Study site

    Blackpool

  • Study site

    Bournemouth

  • Study site

    Bradford

  • Study site

    Cambridge

  • Study site

    Chesterfield

  • Study site

    Coventry

  • Study site

    Devon

  • Study site

    Dundee

  • Study site

    East Horsley

  • Study site

    East Sussex

  • Study site

    Edinburgh

  • Study site

    Essex

  • Study site

    Glasgow

  • Study site

    Harrow

  • Study site

    Leicester

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Middlesbrough

  • Study site

    Orpington

  • Study site

    Peterborough

  • Study site

    Portadown

  • Study site

    Sheffield

  • Study site

    Stirling

  • Study site

    Stockport

  • Study site

    Surrey

  • Study site

    Sutton Coldfield

  • Study site

    Swindon

  • Study site

    Warwickshire

  • Study site

    Wolverhampton

  • Study site

    York

Other trials in United Kingdom

Czechia28 sites

  • Study site

    Benátky nad Jizerou

  • Study site

    Benešov

  • Study site

    Bílovec

  • Study site

    Brno

  • Study site

    Brno-Lesna

  • Study site

    Český Krumlov

  • Study site

    Chrudim

  • Study site

    Havlickux Brod

  • Study site

    Hradec Králové

  • Study site

    Hranice

  • Study site

    Jindřichův Hradec

  • Study site

    Kolín

  • Study site

    Kroměříž

  • Study site

    Mariánské Lázně

  • Study site

    Mladá Boleslav

  • Study site

    Náchod

  • Study site

    Ostrava

  • Study site

    Ostrava-Trebovice

  • Study site

    Pardubice

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Italy26 sites

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China22 sites

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Brazil21 sites

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Russia19 sites

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Hungary18 sites

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Israel18 sites

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Ukraine18 sites

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Argentina17 sites

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Sweden17 sites

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Belgium16 sites

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France16 sites

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Spain16 sites

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Australia13 sites

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South Africa13 sites

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Slovakia11 sites

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Chile10 sites

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About this study

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)

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.

Being tested
warfarin tablets, Edoxaban tablets (high dose regimen-60mg), Edoxaban tablets (low dose regimen-30mg), placebo warfarin, placebo edoxaban
Keywords
Systemic embolic events
Medical subject headings
Stroke, Atrial Fibrillation, Embolism

What participants receive

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

  • warfarin tabletsDrug

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

  • Edoxaban tablets (high dose regimen-60mg)Drug

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

  • Edoxaban tablets (low dose regimen-30mg)Drug

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

  • placebo warfarinDrug

    placebo warfarin

  • placebo edoxabanDrug

    placebo edoxaban

Study groups in NCT00781391
Study groupRoleWhat they receive
Warfarin/placebo edoxabanActive comparatorWarfarin tablets plus placebo Edoxaban tablets
Receives: Drug: warfarin tablets; Drug: placebo edoxaban
high dose edoxaban/placebo warfarinExperimentalEdoxaban tablets (60mg) plus warfarin placebo tablets
Receives: Drug: Edoxaban tablets (high dose regimen-60mg); Drug: placebo warfarin
low dose edoxaban/placebo warfarinExperimentalEdoxaban tablets (30mg) plus warfarin placebo tablets
Receives: Drug: Edoxaban tablets (low dose regimen-30mg); Drug: placebo warfarin

What is being measured

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

  1. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).

    The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.

    Measured: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  2. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).

    The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.

    Measured: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  3. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).

    The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.

    Measured: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  4. Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).

    The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.

    Measured: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  5. Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).

    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.

    Measured: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Secondary outcomes (4)

  1. Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality

    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.

    Measured: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  2. 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

    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.

    Measured: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  3. Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality

    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.

    Measured: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up

  4. Adjudicated Bleeding Events

    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.

    Measured: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up

Timeline

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

  1. First posted29 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionApr 2013
  4. Study completionMay 2013

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21,105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00781391
Sponsor's protocol ID
DU176b-C-U301
Acronym
EngageAFTIMI48
Status last verified
Mar 2015
First submitted
28 Oct 2008
Last updated
5 Mar 2019
Data monitoring committee
Yes
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/

Publications

  • Barco S, Abele C, Ageno W, Klok FA, Wenzel P, Trinchero A, Malcovati L, Konstantinides SV, Valerio L. Warfarin reduces circulating white blood cell count: Post-hoc analysis of two randomized trials. Thromb Res. 2025 Oct;254:109452. doi: 10.1016/j.thromres.2025.109452. Epub 2025 Sep 5.

    PubMed 40925065

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing warfarin tablets, Edoxaban tablets (high dose regimen-60mg) and Edoxaban tablets (low dose regimen-30mg) in people with Stroke and Atrial Fibrillation, run by Daiichi Sankyo at 1,009 sites in 46 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 7 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,009 sites in United States, Germany, Canada, Japan, India and 41 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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 study lists 5 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 NCT00781391, which also lists 36 linked publications.

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 5 Mar 2019.

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