An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

PHASE3CompletedINTERVENTIONAL
Enrollment

14,269

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Atrial FibrillationStrokeEmbolism
Interventions
DRUG

Rivaroxaban

Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

DRUG

Warfarin

Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

DRUG

Matching placebo for Rivaroxaban arm (Warfarin placebo)

Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

DRUG

Matching placebo for Warfarin arm (Rivaroxaban placebo)

Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years

Trial Locations (932)

Unknown

Birmingham

Dothan

Geneva

Mobile

Pell City

Glendale

Phoenix

Scottsdale

Tucson

Fort Smith

Little Rock

Anaheim

Bakersfield

Carmichael

Corona

Fair Oaks

Glendale

Healdsburg

Laguna Hills

Long Beach

Los Angeles

Los Gatos

Mission Viejo

Modesto

Mountain View

Northridge

Oakland

Orange

Pismo Beach

Sacramento

San Diego

San Leandro

Santa Clara

Santa Monica

Santa Rosa

Sylmar

Torrance

Ventura

Yuba City

Boulder

Denver

Littleton

Pueblo

Danbury

Guilford

Newark

Bradenton

Clearwater

Daytona Beach

DeBary

Deerfield Beach

Fort Lauderdale

Fort Myers

Fort Walton Beach

Hialeah

Hollywood

Hudson

Inverness

Jacksonville

Jupiter

Kissimmee

Largo

Melbourne

Miami

Miami Beach

Ocala

Orange Park

Orlando

Ormond Beach

Palm Beach Gardens

Palm Harbor

Port Charlotte

Safety Harbor

St. Petersburg

Tallahassee

Tamarac

Tampa

Albany

Atlanta

Augusta

Columbus

Savannah

Boise

Idaho Falls

Nampa

Aurora

Bannockburn

Chicago

Evergreen Park

Fulton

Lombard

Melrose Park

Moline

Park Ridge

Peoria

Quincy

Rock Island

Rockford

Springfield

Watseka

Anderson

Hammond

Indianapolis

Merrillville

Muncie

Munster

South Bend

Waterloo

Crestview Hills

Edgewood

Lexington

Louisville

Madisonville

Mount Sterling

Owensboro

Houma

Lake Charles

New Orleans

Thibodaux

Vidalia

Bangor

Scarborough

Annapolis

Beltsville

Columbia

Salisbury

Boston

Brighton

Framingham

Bay City

Bridgman

Chelsea

Dearborn

Detroit

Lansing

Mount Clemens

Petoskey

Traverse City

Troy

Minneapolis

Saint Paul

Picayune

Tupelo

Lexington

Springfield

St Louis

Anaconda

Great Falls

Beatrice

Lincoln

Omaha

Las Vegas

Pahrump

Manchester

Bridgewater

Elmer

Haddon Heights

New Brunswick

Paterson

Ridgewood

Sewell

Springfield

Toms River

Wayne

Albuquerque

Brooklyn

Buffalo

Cortlandt Manor

East Syracuse

New York

Northport

Saratoga Springs

Schenectady

Staten Island

Stony Brook

Syracuse

The Bronx

Williamsville

Asheville

Durham

Greensboro

Hickory

Jacksonville

New Bern

Raleigh

Reidsville

Rocky Mount

Statesville

Winston-Salem

Fargo

Minot

Canton

Cincinnati

Columbus

Dayton

Fairfield

Mansfield

Massillon

Maumee

Toledo

Zanesville

Bartlesville

Midwest City

Norman

Oklahoma City

Yukon

Portland

Beaver

Bethlehem

Danville

Doylestown

Jeannette

Jersey Shore

Lansdale

Leetsdale

Lewistown

Norristown

North Wales

Philadelphia

Philipsburg

Phoenixville

Pittsburgh

Sayre

Scranton

Shippensburg

State College

Topton

Wilkes-Barre

Wormleysburg

Wyomissing

Pawtucket

Westerly

Anderson

Charleston

Columbia

Easley

Sumter

Rapid City

Athens

Bristol

Chattanooga

Harriman

Jackson

Johnson City

Kingsport

Knoxville

Lexington

Memphis

Nashville

Amarillo

Beaumont

Brownsville

Corpus Christi

Daingerfield

Dallas

DeSoto

Fort Sam Houston

Fort Worth

Houston

Humble

Hurst

Kerrville

Kingwood

Lubbock

McAllen

Odessa

Plano

San Antonio

Sugar Land

Tomball

Victoria

Murray

Salt Lake City

Burlington

Blacksburg

Chester

Danville

Fairfax

Fredericksburg

Lynchburg

Richmond

Roanoke

Virginia Beach

Williamsburg

Bellingham

Port Orchard

Seattle

Spokane

Tacoma

Vancouver

Burlington

Elkhorn

La Crosse

Milwaukee

Wausau

Bahía Blanca

Buenos Aires

Cipolletti

Corrientes

Córdoba

La Plata

Mar del Plata

Quilmes

Rosario

Salta

San Martín

San Miguel de Tucumán

Santa Fe

Adelaide

Auchenflower

Bedford Park

Box Hill

Caboolture

Cairns

Camperdown

Chermside

Clayton

Coffs Harbour

Footscray

Garran

Geelong

Gosford

Heidelberg Heights

Herston

Hobart

Joondalup

Lismore

Liverpool

Miranda

Nedlands

New Lambton Heights

Parkville

Penrith

Prahran

Reservoir

Southport

Windsor

Wolloongabba

Feldkirch Vorarlberg Vorarlber

Graz

Tulln Niederosterreich Niedero

Vienna

Wien Wien

Antwerp

Bonheiden

Brasschaat

Bruges

Brussels

Ghent

Haine-Saint-Paul

Leuven

Mol

Nivelles

Ottignies

Roeselare

Seraing

Tienen

Belo Horizonte

Blumenau

Brasília

Campina Grande do Sul

Campinas

Campo Grande

Curitiba

Fortaleza

Goiânia

Maceió

Maringá

Marília

Porto Alegre

Recife

Rio de Janeiro

Rio de Janeiro Br

Salvador

Santo André

São Caetano do Sul

São José do Rio Preto

São Paulo

Sorocaba

Uberlândia

Dimitrovgrad

Pleven

Plovdiv

Russel

Sofia

Veliko Tarnovo

Calgary

Edmonton

Abbotsford

Burnaby

Campbell River

Delta

Kelowna

Langley

New Westminster

Penticton

Vancouver

Victoria

West Vancouver

Winnipeg

Moncton

Saint John

St. John's

Halifax

Sydney

Ajax

Beamsville

Belleville

Brampton

Burlington

Cambridge

Corunna

Courtice

E. London

Etobicoke

Fort Erie

Greater Sudbury

Hamilton

Kitchener

Listowel

London

Markham

Mississauga

North Bay

North York

Oakville

Oshawa

Ottawa

Parry Sound

Richmond Hill

Sarnia

Sault Ste. Marie

Scarborough Village

Strathroy

Thornhill

Thunder Bay

Toronto

Waterloo

Whitby

York

Chicoutimi

Greenfield Park

Joliette

Jonquière

Lachine

Longueuil

Mirabel

Montreal

Pointe-Claire

Québec

Saint-Jérôme

Saint-Lambert

Saint-Léonard

Sherbrooke

North Battleford

Saskatoon

Arica I Region

Chila

Concepción VIII

Osorno X Region

Osorno X Región

Rancagua VI Region

San Felipe V Region

Santiago de Chile Rm

Santiago Rm

Temuco IX

Valdivia X Región

Viña Del Mar V Región

Beijing

Changchun

Changsha

Changzhou

Chengdu

Chongqing

Dalian

Daqing

Guangzhou

Haikou

Hangzhou

Harbin

Jinan

Nanjing

Shanghai

Shenyang

Suzhou

Tianjin

Wuhan

Xi'an

Barranquilla

Barranquilla Atlántico Atlanti

Bogota D C

Bogota Dc

Bogotá Dc Dc

Bogotá Dc

Cali Valle Del Cauca

Cali Valley Del Cauca

Medellin Antioquia

Medellín

Santander

Brno

Chomutov

Hradec Králové

Kutná Hora

Liberec

Litomyšl

Náchod

Olomouc

Ostrava

Pardubice

Prague

Praha 10 N/A

Ráj

Slaný

Svitavy

Trutnov

Uherské Hradistì 6

Zlín

Copenhagen

Elsinore

Esbjerg

Frederiksberg

Gentofte Municipality

Hellerup

Hvidovre

Koege

Næstved

Roskilde

Slagelse

Viborg

Helsinki

Jyväskylä

Kuopio

Mikkeli

Oulu

Turku

Albi

Arras

Bayonne

Belfort

Besançon

Béziers Languedoc-Roussillon

Bourg-en-Bresse

Brest

Carcassonne

Clermont-Ferrand

Corbeil-Essonnes

Lille

Marseille

Montbéliard

Montpellier

Paris

Perpignan

Poitiers

Saint-Brieuc

Saint-Jean-de-Verges

Strasbourg

Thionville

Toulouse

Trélivan

Aalen

Berlin

Berlin/Spandau

Biberach

Bochum

Bonn

Chemnitz

Coburg

Dachau

Dortmund

Dresden

Duisburg

Ebersbach

Eilenburg

Erfurt

Essen

Frankfurt

Freiburg im Breisgau

Greifswald

Halle

Hamburg

Hartmannsdorf

Heidelberg

Henstedt-Rhen

Herford

Homburg/Saar

Jena

Jülich

Kamen

Karlsbad

Kassel

Kirchzarten

Krefeld

Leipzig

Ludwigsburg

Ludwigshafen

Lüneburg

Magdeburg

Mainz

Mannheim

Markkleeberg

Meißen

Melsungen

Mönchengladbach

Mühldorf

Mülheim

München

Münster

Neuwied

Nienburg

Nuremberg

Paderborn

Potsdam

Riesa

Rottweil

Sachsen

Siegen

Ulm

Wermsdorf

Witten

Wolmirstedt

Wuppertal

Athens Attica

Ioannina

Maroussi Athens

Pátrai

Piraeus Attica

Tripoli

Voula Attica

Aberdeen

Hong Kong

Kln

Shatin

Budapest

Budapest Nap

Debrecen County

Eger

Gyõr

Gyöngyös

Kesckemet

Miskolc

Nyíregyháza

Pécs

Szeged

Szekszárd

Szombathely

Veszprém

Zalaegerszeg

Ahmedabad

Bangalore

Bikaner

Chennai

Coimbatore

Gandhinagar Guiarat

Hyderabad

Hyderabad Andra Pradesh

Jalandhar

Madurai

Mangalore

Mumbai

Mysore

New Delhi

Pune

Sūraj

Vadodara

Visakhapatnam

Afula

Ashkelon

Hadera

Haifa

Holon

Jerusalem

Nazareth

Netanya

Petah Tikva

Poria – Neve Oved

Rehovot

Safed

Tel Aviv

Tel Litwinsky

Ẕerifin

Kaunas

Klaipėda

Panevezys

Šiauliai

Vilnius

Kelantan

Kuala Lumpur

Sarawak

Aguascalientes

Culiacán Sinaloa/Mèxico

Guadalajara

Hermosillo

Mexico City

Monterrey

Monterrey Nuevo Leòn

Querétaro

San Luis Potosí City

Sinaloa

Zapopan

's-Hertogenbosch

Alkmaar

Amersfoort

Amsterdam

Blaricum

Delft

Gc Tilburg

Gouda

Groningen

Haarlem

Heerlen

Hoofddorp

Hoorn

Leeuwarden

Leidschendam

Maastricht

Meppel

Nijmegen

Schiedam

The Hague

Veldhoven

Christchurch

Dunedin

Grafton

Hamilton

Takapuna Auckland

Wellington

Ålesund

Bergen

Elverum

Hamar

Jessheim

Lillehammer

Moss

Oslo

Sandefjord

Sandnes

Sandvika

Skedsmokorset

L41 Lima Lima

Lima

Lima 1 Lima Lima

Cebuu City

Davao City

Iloilo City

Manila

Quezon City

Bydgoszcz

Gdansk

Gdynia

Katowice

Katowice-Ochojec

Krakow

Lodz

Olsztyn

Opole

Ostrowiec

Oława

Piotrkow Trybunalski

Poznan

Płock

Siedlce

Sieradz

Skierniewice

Starogard Gdanski Nap

Szczecin

Szczecin Nap

Torun

Warsaw

Wroclaw

Włocławek

Żyrardów

Brasov

Bucharest

Craiova

Focşani

Iași

Oradea

Sibiu

Suceava

Tg Mures

Timișoara

Barnaul

Chelyabinsk

Chelyabinsk Chelyabinsk Region

Kemerovo

Krasnoyarsk

Moscow

Nizhny Novgorod

Novosibirsk

Novosibirsk Nap

Orenburg

Perm

Ryazan

Saint Petersburg

Saratov

Smolensk

Tomsk

Tyumen Tyumen Region

Yaroslavl

Yaroslavl Nap

Yekaterinburg

Singapore

Bloemfontein Free State

Bloemfontein Orange Free State

Cape Town

Cape Town Western Cape

Centurion Gauteng

Durban Kwa Zulu Natal

Johannesburg Gauteng

Kempton Park Gauteng

Port Elizabeth Eastern Cape

Pretoria Gauteng

Somerset West Western Cape

Vanderbijlpark

Worcester Western Cape

Anyang

Daegu

Daejeon

Goyang

Kyonggi-Do

Pusan

Seoul

Sungnam

Suwon

A Coruña

Alicante

Almería

Baracaldo Vizcaya

Barcelona

Burgos

Guadalajara

La Corona

Madrid

Málaga

Oviedo

Palma de Mallorca

Pamplona

Pontevedra

Sabadell

San Sebastián Guipúzcoa

Seville

Terrassa

Valencia

Valladolid

Ljungby

Lund

Sala

Skövde

Uppsala

Basel Bs

Bruderholz

Geneva

Zurich

Changhua

Kaohsiung City

Taichung

Tainan City

Taipei

Tamshui

Taoyuan District

Bangkok

Bangkok Noi

Chiang Mai

Pathum Thani

Phathumwan

Ratchatewi

Adana

Ankara

Antalya

Aydin

Denizli

Diyarbakır

Eskişehir

Görükle

Istanbul

Izmir

İzmit

Kayseri

Konya

Malatya Nap

Mersin

Samsun

Cherkassy

Chernihiv

Dnipro

Dnipropetrovsk

Donetsk

Ivano-Frankivsk

Kharkiv

Kirovograd

Kyiv

Luhansk

Lviv

O1103 Kyiv

Odesa

Poltava

Simferopil

Sumy

Ternopil

Uzhhorod

Vinnitsya

Vinnytsia

Zaporizhzhya

Zhytomyr

Aberdeen

Belfast

Birmingham

Bournemouth

Cambridgeshire

Chelmsford

Chesterfield

Colchester

Craigavon

Devon

Dundee

Glasgow

Harrogate

Hull

Leicester

Lincoln

Liverpool

London

Nottingham

Plymouth

Romford

Sheffield

Stirling

Stoke-on-Trent

York

Caracas

Maracaibo Estado Zulia

Maracay Estado Aragua

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY