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

A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

Study Overview

Detailed Description

Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). Patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5. Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD. Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD. The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.

Study Type

Interventional

Enrollment (Actual)

14269

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

      • Bahia Blanca, Argentina
      • Buenos Aires, Argentina
      • Cipolletti, Argentina
      • Ciudad Autonoma De Buenos Aires, Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
      • La Plata, Argentina
      • Mar Del Plata, Argentina
      • Quilmes, Argentina
      • Rosario, Argentina
      • Salta, Argentina
      • San Martin, Argentina
      • Santa Fe, Argentina
      • Tucuman, Argentina
      • Adelaide, Australia
      • Auchenflower, Australia
      • Bedford Park, Australia
      • Box Hill, Australia
      • Caboolture, Australia
      • Cairns, Australia
      • Camperdown, Australia
      • Chermside, Australia
      • Clayton, Australia
      • Coffs Harbour, Australia
      • Footscray, Australia
      • Garran, Australia
      • Geelong, Australia
      • Gosford, Australia
      • Heidelberg Heights, Australia
      • Herston, Australia
      • Hobart, Australia
      • Joondalup, Australia
      • Lismore, Australia
      • Liverpool, Australia
      • Miranda, Australia
      • Nedlands, Australia
      • New Lambton Heights, Australia
      • Parkville, Australia
      • Penrith, Australia
      • Prahran, Australia
      • Reservoir, Australia
      • Southport, Australia
      • Windsor, Australia
      • Wolloongabba, Australia
      • Feldkirch Vorarlberg Vorarlber, Austria
      • Graz, Austria
      • Tulln Niederosterreich Niedero, Austria
      • Wien, Austria
      • Wien N/A, Austria
      • Wien Wien, Austria
      • Antwerpen, Belgium
      • Bonheiden, Belgium
      • Brasschaat, Belgium
      • Brugge, Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Gent, Belgium
      • Haine-Saint-Paul, Belgium
      • Leuven, Belgium
      • Mol, Belgium
      • Nivelles, Belgium
      • Ottignies, Belgium
      • Roeselare, Belgium
      • Seraing, Belgium
      • Tienen, Belgium
      • Belo Horizonte, Brazil
      • Blumenau, Brazil
      • Brasilia, Brazil
      • Campina Grande Do Sul, Brazil
      • Campinas, Brazil
      • Campo Grande, Brazil
      • Curitiba, Brazil
      • Fortaleza, Brazil
      • Goiania, Brazil
      • Goiânia, Brazil
      • Maceio, Brazil
      • Marilia, Brazil
      • Maringa, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Rio De Janeiro, Brazil
      • Rio De Janeiro Br, Brazil
      • Salvador, Brazil
      • Santo Andre, Brazil
      • Sao Caetano Do Sul, Brazil
      • Sao Paulo, Brazil
      • Sorocaba, Brazil
      • São José Do Rio Preto, Brazil
      • São Paulo, Brazil
      • Uberlandia, Brazil
      • Dimitrovgrad, Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Russel, Bulgaria
      • Sofia, Bulgaria
      • Veliko Turnovo, Bulgaria
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada
      • Burnaby, British Columbia, Canada
      • Campbell River, British Columbia, Canada
      • Delta, British Columbia, Canada
      • Kelowna, British Columbia, Canada
      • Langley, British Columbia, Canada
      • New Westminster, British Columbia, Canada
      • Penticton, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
      • West Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
      • Saint John, New Brunswick, Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
      • Sydney, Nova Scotia, Canada
    • Ontario
      • Ajax, Ontario, Canada
      • Beamsville, Ontario, Canada
      • Belleville, Ontario, Canada
      • Brampton, Ontario, Canada
      • Burlington, Ontario, Canada
      • Cambridge, Ontario, Canada
      • Corunna, Ontario, Canada
      • Courtice, Ontario, Canada
      • E. London, Ontario, Canada
      • Etobicoke, Ontario, Canada
      • Fort Erie, Ontario, Canada
      • Hamilton, Ontario, Canada
      • Kitchener, Ontario, Canada
      • Listowel, Ontario, Canada
      • London, Ontario, Canada
      • Markham, Ontario, Canada
      • Mississauga, Ontario, Canada
      • North Bay, Ontario, Canada
      • North York, Ontario, Canada
      • Oakville, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Parry Sound, Ontario, Canada
      • Richmond Hill, Ontario, Canada
      • Sarnia, Ontario, Canada
      • Sault Ste Marie, Ontario, Canada
      • Scarborough, Ontario, Canada
      • Strathroy, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Thornhill, Ontario, Canada
      • Thunder Bay, Ontario, Canada
      • Toronto, Ontario, Canada
      • Waterloo, Ontario, Canada
      • Whitby, Ontario, Canada
      • York, Ontario, Canada
    • Quebec
      • Chicoutimi, Quebec, Canada
      • Greenfield Park, Quebec, Canada
      • Joliette, Quebec, Canada
      • Jonquiere, Quebec, Canada
      • Lachine, Quebec, Canada
      • Longueuil, Quebec, Canada
      • Mirabel, Quebec, Canada
      • Montreal, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
      • Saint-Jerome, Quebec, Canada
      • Saint-Lambert, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • St-Leonard, Quebec, Canada
    • Saskatchewan
      • North Battleford, Saskatchewan, Canada
      • Saskatoon, Saskatchewan, Canada
      • Arica I Region, Chile
      • Chila, Chile
      • Concepción Viii, Chile
      • Osorno X Region, Chile
      • Osorno X Región, Chile
      • Rancagua Vi Region, Chile
      • San Felipe V Region, Chile
      • Santiago De Chile Rm, Chile
      • Santiago Rm, Chile
      • Temuco Ix, Chile
      • Valdivia X Región, Chile
      • Viña Del Mar V Región, Chile
      • Bei Jing, China
      • Beijing, China
      • Changchun, China
      • Changsha, China
      • Changzhou, China
      • Chengdu, China
      • Chongqing, China
      • Dalian, China
      • Daqing, China
      • Guangzhou, China
      • Haikou, China
      • Hangzhou, China
      • Harbin, China
      • Jinan, China
      • Nanjing, China
      • Shanghai, China
      • Shenyang, China
      • Su Zhou, China
      • Suzhou, China
      • Tianjin, China
      • Wuhan, China
      • Xian, China
      • Barranquilla, Colombia
      • Barranquilla Atlántico Atlanti, Colombia
      • Bogota D C, Colombia
      • Bogota Dc, Colombia
      • Bogotá Dc, Colombia
      • Bogotá Dc Dc, Colombia
      • Cali Valle Del Cauca, Colombia
      • Cali Valley Del Cauca, Colombia
      • Medellin, Colombia
      • Medellin Antioquia, Colombia
      • Santander, Colombia
      • Brno 2, Czech Republic
      • Chomutov, Czech Republic
      • Hradec Kralove, Czech Republic
      • Karviná 4, Czech Republic
      • Kutna Hora N/A, Czech Republic
      • Liberec, Czech Republic
      • Litomysl, Czech Republic
      • Náchod 1, Czech Republic
      • Olomouc, Czech Republic
      • Ostrava, Czech Republic
      • Pardubice, Czech Republic
      • Praha, Czech Republic
      • Praha 1, Czech Republic
      • Praha 10 N/A, Czech Republic
      • Praha 2, Czech Republic
      • Praha 4, Czech Republic
      • Praha 5, Czech Republic
      • Praha 8, Czech Republic
      • Slany, Czech Republic
      • Svitavy, Czech Republic
      • Svitavy 2, Czech Republic
      • Trutnov, Czech Republic
      • Uherské Hradistì 6, Czech Republic
      • Zlín 1, Czech Republic
      • Esbjerg, Denmark
      • Frederiksberg, Denmark
      • Gentofte, Denmark
      • Hellerup, Denmark
      • Helsingør, Denmark
      • Hvidovre, Denmark
      • Koege, Denmark
      • København, Denmark
      • Næstved, Denmark
      • Roskilde, Denmark
      • Slagelse, Denmark
      • Viborg, Denmark
      • Helsinki, Finland
      • Jyväskylä N/A, Finland
      • Kuopio, Finland
      • Mikkeli, Finland
      • Oulu, Finland
      • Turku, Finland
      • Albi, France
      • Arras, France
      • Bayonne, France
      • Belfort, France
      • Besancon N/A, France
      • Bourg En Bresse, France
      • Brest, France
      • Béziers Languedoc-Roussillon, France
      • Carcassonne, France
      • Clermont Ferrand, France
      • Corbeil Essonnes, France
      • Lille, France
      • Marseille, France
      • Montbeliard, France
      • Montpellier, France
      • Paris, France
      • Paris Cedex 14, France
      • Perpignan, France
      • Poitiers, France
      • Saint-Brieuc, France
      • St Jean De Verges, France
      • Strasbourg, France
      • Thionville, France
      • Toulouse, France
      • Trelivan, France
      • Aalen, Germany
      • Berlin, Germany
      • Berlin/Spandau, Germany
      • Biberach, Germany
      • Bochum, Germany
      • Bonn, Germany
      • Chemnitz, Germany
      • Coburg, Germany
      • Dachau, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Duisburg, Germany
      • Ebersbach, Germany
      • Eilenburg, Germany
      • Erfurt, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Greifswald, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Hartmannsdorf, Germany
      • Heidelberg, Germany
      • Henstedt-Rhen, Germany
      • Herford, Germany
      • Homburg/Saar, Germany
      • Jena, Germany
      • Julich, Germany
      • Kamen, Germany
      • Karlsbad, Germany
      • Kassel, Germany
      • Kirchzarten, Germany
      • Krefeld, Germany
      • Leipzig, Germany
      • Ludwigsburg, Germany
      • Ludwigshafen, Germany
      • Lüneburg, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Mannheim, Germany
      • Markkleeberg, Germany
      • Meißen, Germany
      • Melsungen, Germany
      • Monchengladbach, Germany
      • Munchen, Germany
      • Mühldorf, Germany
      • Mülheim, Germany
      • Münster, Germany
      • Neuwied, Germany
      • Nienburg, Germany
      • Nuernberg, Germany
      • Paderborn, Germany
      • Potsdam, Germany
      • Riesa, Germany
      • Rottweil, Germany
      • Sachsen, Germany
      • Siegen, Germany
      • Ulm, Germany
      • Wermsdorf, Germany
      • Witten, Germany
      • Wolmirstedt, Germany
      • Wuppertal, Germany
      • Athens Attica, Greece
      • Ioannina, Greece
      • Maroussi Athens, Greece
      • Patra, Greece
      • Piraeus Attica, Greece
      • Tripoli, Greece
      • Voula Attica, Greece
      • Aberdeen, Hong Kong
      • Hk, Hong Kong
      • Kln, Hong Kong
      • Sha Tin, Hong Kong
      • Budapest, Hungary
      • Budapest N/A, Hungary
      • Budapest Nap, Hungary
      • Debrecen County, Hungary
      • Eger, Hungary
      • Gyongyos, Hungary
      • Gyõr, Hungary
      • Kesckemet, Hungary
      • Miskolc, Hungary
      • Nyiregyhaza, Hungary
      • Pecs, Hungary
      • Szeged, Hungary
      • Szekszard, Hungary
      • Szombathely, Hungary
      • Veszprem, Hungary
      • Zalaegerszeg, Hungary
      • Ahmedabad, India
      • Bangalore, India
      • Bikaner, India
      • Chennai, India
      • Coimbatore, India
      • Gandhinagar Guiarat, India
      • Hyderabad, India
      • Hyderabad Andra Pradesh, India
      • Jalandhar, India
      • Madurai, India
      • Mangalore, India
      • Mumbai, India
      • Mysore, India
      • New Delhi, India
      • Pune, India
      • Suraj, India
      • Vadodara, India
      • Vishakapatnam, India
      • Afula, Israel
      • Ashkelon, Israel
      • Hadera, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Nazareth, Israel
      • Netanya, Israel
      • Petach-Tikva, Israel
      • Petah-Tikva, Israel
      • Poriya, Israel
      • Rehovot, Israel
      • Safed, Israel
      • Tel Aviv, Israel
      • Tel Hashomer, Israel
      • Zerifin, Israel
      • Anyang, Korea, Republic of
      • Daegu, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Goyang, Korea, Republic of
      • Kyonggi-Do, Korea, Republic of
      • Pusan, Korea, Republic of
      • Seoul, Korea, Republic of
      • Sungnam, Korea, Republic of
      • Suwon, Korea, Republic of
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Panevezys, Lithuania
      • Siauliai, Lithuania
      • Vilnius, Lithuania
      • Kelantan, Malaysia
      • Kuala Lumpur, Malaysia
      • Sarawak, Malaysia
      • Aguascalientes, Mexico
      • Ciudad De Mexico, Mexico
      • Culiacán Sinaloa/Mèxico, Mexico
      • Guadalajara, Mexico
      • Hermosillo, Mexico
      • Monterrey, Mexico
      • Monterrey Nuevo Leòn, Mexico
      • Queretaro, Mexico
      • San Luis Potosi, Mexico
      • Sinaloa, Mexico
      • Zapopan, Mexico
      • 'S-Gravenhage, Netherlands
      • Alkmaar, Netherlands
      • Amersfoort, Netherlands
      • Amsterdam, Netherlands
      • Blaricum, Netherlands
      • Delft, Netherlands
      • Den Bosch, Netherlands
      • Den Haag, Netherlands
      • Gc Tilburg, Netherlands
      • Gouda, Netherlands
      • Groningen, Netherlands
      • Haarlem, Netherlands
      • Heerlen, Netherlands
      • Hoofddorp, Netherlands
      • Hoorn Nh, Netherlands
      • Leeuwarden, Netherlands
      • Leidschendam, Netherlands
      • Maastricht, Netherlands
      • Meppel, Netherlands
      • Nijmegen, Netherlands
      • Schiedam, Netherlands
      • Veldhoven, Netherlands
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Grafton, New Zealand
      • Hamilton, New Zealand
      • Takapuna Auckland, New Zealand
      • Wellington, New Zealand
      • Alesund, Norway
      • Bergen, Norway
      • Elverum, Norway
      • Hamar, Norway
      • Jessheim, Norway
      • Lillehammer, Norway
      • Moss, Norway
      • Oslo, Norway
      • Sandefjord, Norway
      • Sandnes, Norway
      • Sandvika, Norway
      • Skedsmokorset, Norway
      • L41 Lima Lima, Peru
      • Lima, Peru
      • Lima 1 Lima Lima, Peru
      • Cebuu City, Philippines
      • Davao City, Philippines
      • Iloilo City, Philippines
      • Manila City, Philippines
      • Quezon City, Philippines
      • Bydgoszcz, Poland
      • Bydgoszcz N/A, Poland
      • Gdansk, Poland
      • Gdynia, Poland
      • Katowice, Poland
      • Katowice-Ochojec, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Olawa, Poland
      • Olsztyn, Poland
      • Opole, Poland
      • Ostrowiec N/A, Poland
      • Piotrkow Trybunalski, Poland
      • Plock, Poland
      • Poznan, Poland
      • Siedlce, Poland
      • Sieradz N/A, Poland
      • Skierniewice, Poland
      • Starogard Gdanski Nap, Poland
      • Szczecin, Poland
      • Szczecin Nap, Poland
      • Torun, Poland
      • Warsaw, Poland
      • Warszawa, Poland
      • Warszawa N/A, Poland
      • Wloclawek, Poland
      • Wroclaw, Poland
      • Wroclaw N/A, Poland
      • Zyrardow N/A, Poland
      • Brasov, Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Craiova, Romania
      • Focsani, Romania
      • Iasi, Romania
      • Oradea, Romania
      • Sibiu, Romania
      • Suceava, Romania
      • Tg Mures, Romania
      • Timisoara, Romania
      • Barnaul, Russian Federation
      • Chelyabinsk, Russian Federation
      • Chelyabinsk Chelyabinsk Region, Russian Federation
      • Ekaterinburg, Russian Federation
      • Kemerovo, Russian Federation
      • Krasnoyarsk, Russian Federation
      • Moscow, Russian Federation
      • Moscow N/A, Russian Federation
      • Nizhni Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Novosibirsk Nap, Russian Federation
      • Orenburg, Russian Federation
      • Perm, Russian Federation
      • Ryazan, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Tomsk, Russian Federation
      • Tyumen Tyumen Region, Russian Federation
      • Yaroslavl, Russian Federation
      • Yaroslavl Nap, Russian Federation
      • Singapore, Singapore
      • Bloemfontein Free State, South Africa
      • Bloemfontein Orange Free State, South Africa
      • Cape Town, South Africa
      • Cape Town Western Cape, South Africa
      • Centurion Gauteng, South Africa
      • Durban Kwa Zulu Natal, South Africa
      • Johannesburg Gauteng, South Africa
      • Kempton Park Gauteng, South Africa
      • Port Elizabeth Eastern Cape, South Africa
      • Pretoria Gauteng, South Africa
      • Somerset West Western Cape, South Africa
      • Van Der Bijl Park, South Africa
      • Worcester Western Cape, South Africa
      • A Coruna, Spain
      • Alicante N/A, Spain
      • Almeria, Spain
      • Baracaldo Vizcaya, Spain
      • Barcelona, Spain
      • Burgos, Spain
      • Guadalajara, Spain
      • La Corona, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Oviedo, Spain
      • Palma De Mallorca, Spain
      • Pamplona, Spain
      • Pontevedra, Spain
      • Sabadell, Spain
      • San Sebastián Guipúzcoa, Spain
      • Sevilla, Spain
      • Terrassa, Spain
      • Valencia, Spain
      • Valladolid, Spain
      • Ljungby, Sweden
      • Lund, Sweden
      • Sala, Sweden
      • Skövde, Sweden
      • Uppsala, Sweden
      • Basel Bs, Switzerland
      • Bruderholz, Switzerland
      • Geneve, Switzerland
      • Zurich, Switzerland
      • Changhua, Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Tamshui, Taiwan
      • Tao-Yuan, Taiwan
      • Bangkok, Thailand
      • Bangkok Noi, Thailand
      • Chiang Mai, Thailand
      • Pathumthani, Thailand
      • Phathumwan, Thailand
      • Ratchatewi, Thailand
      • Adana, Turkey
      • Ankara, Turkey
      • Antalya, Turkey
      • Aydin, Turkey
      • Denizli, Turkey
      • Diyarbakir, Turkey
      • Eskisehir, Turkey
      • Görükle, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Izmit, Turkey
      • Kayseri, Turkey
      • Konya, Turkey
      • Malatya Nap, Turkey
      • Mersin, Turkey
      • Samsun, Turkey
      • Cherkassy, Ukraine
      • Chernigiv, Ukraine
      • Dnepropetrovsk, Ukraine
      • Dnipropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kharkov, Ukraine
      • Kirovograd, Ukraine
      • Kyiv, Ukraine
      • Lugansk, Ukraine
      • Lviv, Ukraine
      • O1103 Kyiv, Ukraine
      • Odesa, Ukraine
      • Poltava, Ukraine
      • Simferopil, Ukraine
      • Sumy, Ukraine
      • Ternopil, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsya, Ukraine
      • Vinnytsia, Ukraine
      • Zaporizhzhya, Ukraine
      • Zhytomyr, Ukraine
      • Aberdeen, United Kingdom
      • Belfast, United Kingdom
      • Birmingham, United Kingdom
      • Bournemouth, United Kingdom
      • Cambridgeshire, United Kingdom
      • Chelmsford, United Kingdom
      • Chesterfield, United Kingdom
      • Colchester, United Kingdom
      • Craigavon, United Kingdom
      • Devon, United Kingdom
      • Dundee, United Kingdom
      • Glasgow, United Kingdom
      • Harrogate, United Kingdom
      • Hull, United Kingdom
      • Leicester, United Kingdom
      • Lincoln, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Romford, United Kingdom
      • Sheffield, United Kingdom
      • Stirling, United Kingdom
      • Stoke On Trent, United Kingdom
      • York, United Kingdom
    • Alabama
      • Birmingham, Alabama, United States
      • Dothan, Alabama, United States
      • Geneva, Alabama, United States
      • Mobile, Alabama, United States
      • Pell City, Alabama, United States
    • Arizona
      • Glendale, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Fort Smith, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Bakersfield, California, United States
      • Carmichael, California, United States
      • Corona, California, United States
      • Fair Oaks, California, United States
      • Glendale, California, United States
      • Healdsburg, California, United States
      • Laguna Hills, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Los Gatos, California, United States
      • Mission Viejo, California, United States
      • Modesto, California, United States
      • Mountain View, California, United States
      • Northridge, California, United States
      • Oakland, California, United States
      • Orange, California, United States
      • Pismo Beach, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Leandro, California, United States
      • Santa Clara, California, United States
      • Santa Monica, California, United States
      • Santa Rosa, California, United States
      • Sylmar, California, United States
      • Torrance, California, United States
      • Ventura, California, United States
      • Yuba City, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Denver, Colorado, United States
      • Littleton, Colorado, United States
      • Pueblo, Colorado, United States
    • Connecticut
      • Danbury, Connecticut, United States
      • Guilford, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Bradenton, Florida, United States
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States
      • Debary, Florida, United States
      • Deerfield Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • Fort Walton Beach, Florida, United States
      • Hialeah, Florida, United States
      • Hollywood, Florida, United States
      • Hudson, Florida, United States
      • Inverness, Florida, United States
      • Jacksonville, Florida, United States
      • Jupiter, Florida, United States
      • Kissimmee, Florida, United States
      • Largo, Florida, United States
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • Miami Beach, Florida, United States
      • Ocala, Florida, United States
      • Orange Park, Florida, United States
      • Orlando, Florida, United States
      • Ormond Beach, Florida, United States
      • Palm Beach Gardens, Florida, United States
      • Palm Harbor, Florida, United States
      • Port Charlotte, Florida, United States
      • Safety Harbor, Florida, United States
      • St. Petersburg, Florida, United States
      • Tallahassee, Florida, United States
      • Tamarac, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Albany, Georgia, United States
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Columbus, Georgia, United States
      • Savannah, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
      • Idaho Falls, Idaho, United States
      • Nampa, Idaho, United States
    • Illinois
      • Aurora, Illinois, United States
      • Bannockburn, Illinois, United States
      • Chicago, Illinois, United States
      • Evergreen Park, Illinois, United States
      • Fulton, Illinois, United States
      • Lombard, Illinois, United States
      • Melrose Park, Illinois, United States
      • Moline, Illinois, United States
      • Park Ridge, Illinois, United States
      • Peoria, Illinois, United States
      • Quincy, Illinois, United States
      • Rock Island, Illinois, United States
      • Rockford, Illinois, United States
      • Springfield, Illinois, United States
      • Watseka, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
      • Hammond, Indiana, United States
      • Indianapolis, Indiana, United States
      • Merrillville, Indiana, United States
      • Muncie, Indiana, United States
      • Munster, Indiana, United States
      • South Bend, Indiana, United States
    • Iowa
      • Waterloo, Iowa, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Edgewood, Kentucky, United States
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
      • Madisonville, Kentucky, United States
      • Mt Sterling, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Louisiana
      • Houma, Louisiana, United States
      • Lake Charles, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Thibodaux, Louisiana, United States
      • Vidalia, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
      • Scarborough, Maine, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Beltsville, Maryland, United States
      • Columbia, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Brighton, Massachusetts, United States
      • Framingham, Massachusetts, United States
    • Michigan
      • Bay City, Michigan, United States
      • Bridgman, Michigan, United States
      • Chelsea, Michigan, United States
      • Dearborn, Michigan, United States
      • Detroit, Michigan, United States
      • Lansing, Michigan, United States
      • Mount Clemens, Michigan, United States
      • Petoskey, Michigan, United States
      • Traverse City, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Mississippi
      • Picayune, Mississippi, United States
      • Tupelo, Mississippi, United States
    • Missouri
      • Lexington, Missouri, United States
      • Saint Louis, Missouri, United States
      • Springfield, Missouri, United States
    • Montana
      • Anaconda, Montana, United States
      • Great Falls, Montana, United States
    • Nebraska
      • Beatrice, Nebraska, United States
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
      • Pahrump, Nevada, United States
    • New Hampshire
      • Manchester, New Hampshire, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • Elmer, New Jersey, United States
      • Haddon Heights, New Jersey, United States
      • New Brunswick, New Jersey, United States
      • Paterson, New Jersey, United States
      • Ridgewood, New Jersey, United States
      • Sewell, New Jersey, United States
      • Springfield, New Jersey, United States
      • Toms River, New Jersey, United States
      • Wayne, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Bronx, New York, United States
      • Brooklyn, New York, United States
      • Buffalo, New York, United States
      • Cortlandt Manor, New York, United States
      • East Syracuse, New York, United States
      • New York, New York, United States
      • Northport, New York, United States
      • Saratoga Springs, New York, United States
      • Schenectady, New York, United States
      • Staten Island, New York, United States
      • Stony Brook, New York, United States
      • Syracuse, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Durham, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Hickory, North Carolina, United States
      • Jacksonville, North Carolina, United States
      • New Bern, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Reidsville, North Carolina, United States
      • Rocky Mount, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
      • Minot, North Dakota, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Fairfield, Ohio, United States
      • Mansfield, Ohio, United States
      • Massillon, Ohio, United States
      • Maumee, Ohio, United States
      • Toledo, Ohio, United States
      • Zanesville, Ohio, United States
    • Oklahoma
      • Bartlesville, Oklahoma, United States
      • Midwest City, Oklahoma, United States
      • Norman, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
      • Yukon, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Jeannette, Pennsylvania, United States
      • Jersey Shore, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Leetsdale, Pennsylvania, United States
      • Lewistown, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • North Wales, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Philipsburg, Pennsylvania, United States
      • Phoenixville, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
      • Scranton, Pennsylvania, United States
      • Shippensburg, Pennsylvania, United States
      • State College, Pennsylvania, United States
      • Topton, Pennsylvania, United States
      • Wilkes Barre, Pennsylvania, United States
      • Wormleysburg, Pennsylvania, United States
      • Wyomissing, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
      • Westerly, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Easley, South Carolina, United States
      • Sumter, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Athens, Tennessee, United States
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Harriman, Tennessee, United States
      • Jackson, Tennessee, United States
      • Johnson City, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Lexington, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Beaumont, Texas, United States
      • Brownsville, Texas, United States
      • Corpus Christi, Texas, United States
      • Daingerfield, Texas, United States
      • Dallas, Texas, United States
      • Desoto, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Humble, Texas, United States
      • Hurst, Texas, United States
      • Kerrville, Texas, United States
      • Kingwood, Texas, United States
      • Lubbock, Texas, United States
      • Mcallen, Texas, United States
      • Odessa, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • Sugar Land, Texas, United States
      • Tomball, Texas, United States
      • Victoria, Texas, United States
    • Utah
      • Murray, Utah, United States
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Blacksburg, Virginia, United States
      • Chester, Virginia, United States
      • Danville, Virginia, United States
      • Fairfax, Virginia, United States
      • Fredericksburg, Virginia, United States
      • Lynchburg, Virginia, United States
      • Richmond, Virginia, United States
      • Roanoke, Virginia, United States
      • Virginia Beach, Virginia, United States
      • Williamsburg, Virginia, United States
    • Washington
      • Bellingham, Washington, United States
      • Port Orchard, Washington, United States
      • Seattle, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
      • Vancouver, Washington, United States
    • Wisconsin
      • Burlington, Wisconsin, United States
      • Elkhorn, Wisconsin, United States
      • La Crosse, Wisconsin, United States
      • Milwaukee, Wisconsin, United States
      • Wausau, Wisconsin, United States
      • Caracas, Venezuela
      • Maracaibo Estado Zulia, Venezuela
      • Maracay Estado Aragua, Venezuela

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
  • History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus

Exclusion Criteria:

  • Significant mitral stenosis
  • Transient atrial fibrillation caused by a reversible disorder
  • Active internal bleeding
  • Severe disabling stroke
  • History of intracranial bleeding
  • Hemorrhagic disorders

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
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
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
Experimental: 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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
Time Frame: Up to 4 years
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
Time Frame: Up to 4 years
The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
Time Frame: Up to 4 years
The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
Time Frame: Up to 4 years
The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
Time Frame: Up to 4 years
The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
Time Frame: Up to 4 years
The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
Time Frame: Up to 4 years
The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
Time Frame: Up to 4 years
The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.
Up to 4 years
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
Time Frame: Up to 4 years
The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.
Up to 4 years
All-cause Mortality
Time Frame: Up to 4 years
The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.
Up to 4 years

Collaborators and Investigators

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

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

December 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 23, 2006

First Submitted That Met QC Criteria

November 23, 2006

First Posted (Estimate)

November 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

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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