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
NCT ID: NCT00403767
Last Updated: 2014-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
14269 participants
INTERVENTIONAL
2006-12-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rivaroxaban
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)
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
Warfarin
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
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
Interventions
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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)
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Birmingham, Alabama, United States
Dothan, Alabama, United States
Geneva, Alabama, United States
Mobile, Alabama, United States
Pell City, Alabama, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
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
Boulder, Colorado, United States
Denver, Colorado, United States
Littleton, Colorado, United States
Pueblo, Colorado, United States
Danbury, Connecticut, United States
Guilford, Connecticut, United States
Newark, Delaware, United States
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
Albany, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, United States
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
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
Waterloo, Iowa, United States
Crestview Hills, Kentucky, United States
Edgewood, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Mount Sterling, Kentucky, United States
Owensboro, Kentucky, United States
Houma, Louisiana, United States
Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States
Thibodaux, Louisiana, United States
Vidalia, Louisiana, United States
Bangor, Maine, United States
Scarborough, Maine, United States
Annapolis, Maryland, United States
Beltsville, Maryland, United States
Columbia, Maryland, United States
Salisbury, Maryland, United States
Boston, Massachusetts, United States
Brighton, Massachusetts, United States
Framingham, Massachusetts, United States
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
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Picayune, Mississippi, United States
Tupelo, Mississippi, United States
Lexington, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Anaconda, Montana, United States
Great Falls, Montana, United States
Beatrice, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Manchester, New Hampshire, United States
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
Albuquerque, New Mexico, 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
The Bronx, New York, United States
Williamsville, New York, United States
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
Fargo, North Dakota, United States
Minot, North Dakota, United States
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
Bartlesville, Oklahoma, United States
Midwest City, Oklahoma, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Yukon, Oklahoma, United States
Portland, Oregon, United States
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
Pawtucket, Rhode Island, United States
Westerly, Rhode Island, United States
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
Rapid City, South Dakota, United States
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
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
Murray, Utah, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
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
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
Burlington, Wisconsin, United States
Elkhorn, Wisconsin, United States
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Wausau, Wisconsin, United States
Bahía Blanca, , Argentina
Buenos Aires, , Argentina
Cipolletti, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Mar del Plata, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Martín, , Argentina
San Miguel de Tucumán, , Argentina
Santa Fe, , 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
Vienna, , Austria
Wien Wien, , Austria
Antwerp, , Belgium
Bonheiden, , Belgium
Brasschaat, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Haine-Saint-Paul, , Belgium
Leuven, , Belgium
Mol, , Belgium
Nivelles, , Belgium
Ottignies, , Belgium
Roeselare, , Belgium
Seraing, , Belgium
Tienen, , Belgium
Belo Horizonte, , Brazil
Blumenau, , Brazil
Brasília, , Brazil
Campina Grande do Sul, , Brazil
Campinas, , Brazil
Campo Grande, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
Goiânia, , Brazil
Maceió, , Brazil
Maringá, , Brazil
Marília, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Rio de Janeiro, , Brazil
Rio de Janeiro Br, , Brazil
Salvador, , Brazil
Santo André, , Brazil
São Caetano do Sul, , Brazil
São José do Rio Preto, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Uberlândia, , Brazil
Dimitrovgrad, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Russel, , Bulgaria
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
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
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
Saint John, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Sydney, Nova Scotia, Canada
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
Greater Sudbury, 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 Village, Ontario, Canada
Strathroy, Ontario, Canada
Thornhill, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Whitby, Ontario, Canada
York, Ontario, Canada
Chicoutimi, Quebec, Canada
Greenfield Park, Quebec, Canada
Joliette, Quebec, Canada
Jonquière, Quebec, Canada
Lachine, Quebec, Canada
Longueuil, Quebec, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Saint-Lambert, Quebec, Canada
Saint-Léonard, Quebec, Canada
Sherbrooke, Quebec, Canada
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
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
Suzhou, , China
Tianjin, , China
Wuhan, , China
Xi'an, , China
Barranquilla, , Colombia
Barranquilla Atlántico Atlanti, , Colombia
Bogota D C, , Colombia
Bogota Dc, , Colombia
Bogotá Dc Dc, , Colombia
Bogotá Dc, , Colombia
Cali Valle Del Cauca, , Colombia
Cali Valley Del Cauca, , Colombia
Medellin Antioquia, , Colombia
Medellín, , Colombia
Santander, , Colombia
Brno, , Czechia
Chomutov, , Czechia
Hradec Králové, , Czechia
Kutná Hora, , Czechia
Liberec, , Czechia
Litomyšl, , Czechia
Náchod, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Praha 10 N/A, , Czechia
Ráj, , Czechia
Slaný, , Czechia
Svitavy, , Czechia
Trutnov, , Czechia
Uherské Hradistì 6, , Czechia
Zlín, , Czechia
Copenhagen, , Denmark
Elsinore, , Denmark
Esbjerg, , Denmark
Frederiksberg, , Denmark
Gentofte Municipality, , Denmark
Hellerup, , Denmark
Hvidovre, , Denmark
Koege, , Denmark
Næstved, , Denmark
Roskilde, , Denmark
Slagelse, , Denmark
Viborg, , Denmark
Helsinki, , Finland
Jyväskylä, , Finland
Kuopio, , Finland
Mikkeli, , Finland
Oulu, , Finland
Turku, , Finland
Albi, , France
Arras, , France
Bayonne, , France
Belfort, , France
Besançon, , France
Béziers Languedoc-Roussillon, , France
Bourg-en-Bresse, , France
Brest, , France
Carcassonne, , France
Clermont-Ferrand, , France
Corbeil-Essonnes, , France
Lille, , France
Marseille, , France
Montbéliard, , France
Montpellier, , France
Paris, , France
Perpignan, , France
Poitiers, , France
Saint-Brieuc, , France
Saint-Jean-de-Verges, , France
Strasbourg, , France
Thionville, , France
Toulouse, , France
Trélivan, , 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 im Breisgau, , Germany
Greifswald, , Germany
Halle, , Germany
Hamburg, , Germany
Hartmannsdorf, , Germany
Heidelberg, , Germany
Henstedt-Rhen, , Germany
Herford, , Germany
Homburg/Saar, , Germany
Jena, , Germany
Jülich, , 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
Mönchengladbach, , Germany
Mühldorf, , Germany
Mülheim, , Germany
München, , Germany
Münster, , Germany
Neuwied, , Germany
Nienburg, , Germany
Nuremberg, , 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
Pátrai, , Greece
Piraeus Attica, , Greece
Tripoli, , Greece
Voula Attica, , Greece
Aberdeen, , Hong Kong
Hong Kong, , Hong Kong
Kln, , Hong Kong
Shatin, , Hong Kong
Budapest, , Hungary
Budapest Nap, , Hungary
Debrecen County, , Hungary
Eger, , Hungary
Gyõr, , Hungary
Gyöngyös, , Hungary
Kesckemet, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Szombathely, , Hungary
Veszprém, , 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
Sūraj, , India
Vadodara, , India
Visakhapatnam, , India
Afula, , Israel
Ashkelon, , Israel
Hadera, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Nazareth, , Israel
Netanya, , Israel
Petah Tikva, , Israel
Poria – Neve Oved, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Sarawak, , Malaysia
Aguascalientes, , Mexico
Culiacán Sinaloa/Mèxico, , Mexico
Guadalajara, , Mexico
Hermosillo, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Monterrey Nuevo Leòn, , Mexico
Querétaro, , Mexico
San Luis Potosí City, , Mexico
Sinaloa, , Mexico
Zapopan, , Mexico
's-Hertogenbosch, , Netherlands
Alkmaar, , Netherlands
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Blaricum, , Netherlands
Delft, , Netherlands
Gc Tilburg, , Netherlands
Gouda, , Netherlands
Groningen, , Netherlands
Haarlem, , Netherlands
Heerlen, , Netherlands
Hoofddorp, , Netherlands
Hoorn, , Netherlands
Leeuwarden, , Netherlands
Leidschendam, , Netherlands
Maastricht, , Netherlands
Meppel, , Netherlands
Nijmegen, , Netherlands
Schiedam, , Netherlands
The Hague, , Netherlands
Veldhoven, , Netherlands
Christchurch, , New Zealand
Dunedin, , New Zealand
Grafton, , New Zealand
Hamilton, , New Zealand
Takapuna Auckland, , New Zealand
Wellington, , New Zealand
Ålesund, , 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, , Philippines
Quezon City, , Philippines
Bydgoszcz, , Poland
Gdansk, , Poland
Gdynia, , Poland
Katowice, , Poland
Katowice-Ochojec, , Poland
Krakow, , Poland
Lodz, , Poland
Olsztyn, , Poland
Opole, , Poland
Ostrowiec, , Poland
Oława, , Poland
Piotrkow Trybunalski, , Poland
Poznan, , Poland
Płock, , Poland
Siedlce, , Poland
Sieradz, , Poland
Skierniewice, , Poland
Starogard Gdanski Nap, , Poland
Szczecin, , Poland
Szczecin Nap, , Poland
Torun, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Włocławek, , Poland
Żyrardów, , Poland
Brasov, , Romania
Bucharest, , Romania
Craiova, , Romania
Focşani, , Romania
Iași, , Romania
Oradea, , Romania
Sibiu, , Romania
Suceava, , Romania
Tg Mures, , Romania
Timișoara, , Romania
Barnaul, , Russia
Chelyabinsk, , Russia
Chelyabinsk Chelyabinsk Region, , Russia
Kemerovo, , Russia
Krasnoyarsk, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Novosibirsk Nap, , Russia
Orenburg, , Russia
Perm, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Tomsk, , Russia
Tyumen Tyumen Region, , Russia
Yaroslavl, , Russia
Yaroslavl Nap, , Russia
Yekaterinburg, , Russia
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
Vanderbijlpark, , South Africa
Worcester Western Cape, , South Africa
Anyang, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Goyang, , South Korea
Kyonggi-Do, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Sungnam, , South Korea
Suwon, , South Korea
A Coruña, , Spain
Alicante, , Spain
Almería, , Spain
Baracaldo Vizcaya, , Spain
Barcelona, , Spain
Burgos, , Spain
Guadalajara, , Spain
La Corona, , Spain
Madrid, , Spain
Málaga, , Spain
Oviedo, , Spain
Palma de Mallorca, , Spain
Pamplona, , Spain
Pontevedra, , Spain
Sabadell, , Spain
San Sebastián Guipúzcoa, , Spain
Seville, , Spain
Terrassa, , Spain
Valencia, , Spain
Valladolid, , Spain
Ljungby, , Sweden
Lund, , Sweden
Sala, , Sweden
Skövde, , Sweden
Uppsala, , Sweden
Basel Bs, , Switzerland
Bruderholz, , Switzerland
Geneva, , Switzerland
Zurich, , Switzerland
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Tamshui, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Bangkok Noi, , Thailand
Chiang Mai, , Thailand
Pathum Thani, , Thailand
Phathumwan, , Thailand
Ratchatewi, , Thailand
Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Aydin, , Turkey (Türkiye)
Denizli, , Turkey (Türkiye)
Diyarbakır, , Turkey (Türkiye)
Eskişehir, , Turkey (Türkiye)
Görükle, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
İzmit, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Malatya Nap, , Turkey (Türkiye)
Mersin, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Cherkassy, , Ukraine
Chernihiv, , Ukraine
Dnipro, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kirovograd, , Ukraine
Kyiv, , Ukraine
Luhansk, , Ukraine
Lviv, , Ukraine
O1103 Kyiv, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Simferopil, , Ukraine
Sumy, , Ukraine
Ternopil, , Ukraine
Uzhhorod, , 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
Caracas, , Venezuela
Maracaibo Estado Zulia, , Venezuela
Maracay Estado Aragua, , Venezuela
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.
Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.
Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.
Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.
Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Impact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF. Am Heart J. 2018 Jun;200:102-109. doi: 10.1016/j.ahj.2018.02.013. Epub 2018 Feb 27.
Leef GC, Hellkamp AS, Patel MR, Becker RC, Berkowitz SD, Breithardt G, Halperin JL, Hankey GJ, Hacke W, Nessel CC, Singer DE, Fox KAA, Mahaffey KW, Piccini JP. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial. J Am Heart Assoc. 2017 Jun 14;6(6):e004663. doi: 10.1161/JAHA.116.004663.
Balla SR, Cyr DD, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial). Am J Cardiol. 2017 Jun 15;119(12):1989-1996. doi: 10.1016/j.amjcard.2017.03.028. Epub 2017 Mar 29.
Sun Y, Hu D, Stevens S, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Fox KAA, Patel MR. Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial. Thromb Res. 2017 Aug;156:184-190. doi: 10.1016/j.thromres.2017.04.010. Epub 2017 Apr 13.
Lindner SM, Fordyce CB, Hellkamp AS, Lokhnygina Y, Piccini JP, Breithardt G, Mahaffey KW, Singer DE, Hacke W, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Becker RC, Fox KA, Patel MR; ROCKET AF Steering Committee and Investigators. Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin: A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis. Circulation. 2017 Mar 7;135(10):1001-1003. doi: 10.1161/CIRCULATIONAHA.116.024666. No abstract available.
Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC, Berkowitz SD, Breithardt G, Fox KA, Mahaffey KW, Nessel CC, Singer DE, Patel MR; ROCKET AF Steering Committee and Investigators. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation. 2016 Jul 5;134(1):37-47. doi: 10.1161/CIRCULATIONAHA.116.021890.
Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL, Breithardt G, Singer DE, Hankey GJ, Hacke W, Becker RC, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Steering Committee & Investigators; ROCKET AF Steering Committee Investigators. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016 Mar 8;5(3):e002197. doi: 10.1161/JAHA.115.002197.
Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Lokhnygina Y, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Califf RM, Fox KA, Patel MR; ROCKET AF Steering Committee & Investigators. Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban. Heart. 2016 Jul 1;102(13):1036-43. doi: 10.1136/heartjnl-2015-308120. Epub 2016 Feb 17.
Piccini JP, Hellkamp AS, Washam JB, Becker RC, Breithardt G, Berkowitz SD, Halperin JL, Hankey GJ, Hacke W, Mahaffey KW, Nessel CC, Singer DE, Fox KA, Patel MR. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2016 Jan 26;133(4):352-60. doi: 10.1161/CIRCULATIONAHA.115.018544. Epub 2015 Dec 16.
Bansilal S, Bloomgarden Z, Halperin JL, Hellkamp AS, Lokhnygina Y, Patel MR, Becker RC, Breithardt G, Hacke W, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Piccini JP, Mahaffey KW, Fox KA; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J. 2015 Oct;170(4):675-682.e8. doi: 10.1016/j.ahj.2015.07.006. Epub 2015 Jul 17.
Washam JB, Stevens SR, Lokhnygina Y, Halperin JL, Breithardt G, Singer DE, Mahaffey KW, Hankey GJ, Berkowitz SD, Nessel CC, Fox KA, Califf RM, Piccini JP, Patel MR; ROCKET AF Steering Committee and Investigators. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet. 2015 Jun 13;385(9985):2363-70. doi: 10.1016/S0140-6736(14)61836-5. Epub 2015 Mar 6.
Singer DE, Hellkamp AS, Yuan Z, Lokhnygina Y, Patel MR, Piccini JP, Hankey GJ, Breithardt G, Halperin JL, Becker RC, Hacke W, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2015 Mar 3;4(3):e001349. doi: 10.1161/JAHA.114.001349.
Girgis IG, Patel MR, Peters GR, Moore KT, Mahaffey KW, Nessel CC, Halperin JL, Califf RM, Fox KA, Becker RC. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF. J Clin Pharmacol. 2014 Aug;54(8):917-27. doi: 10.1002/jcph.288. Epub 2014 Mar 26.
Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.
Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KA, Califf RM; ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.
Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.
van Diepen S, Hellkamp AS, Patel MR, Becker RC, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Califf RM, Fox KA, Mahaffey KW. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013 Jul;6(4):740-7. doi: 10.1161/CIRCHEARTFAILURE.113.000212. Epub 2013 May 30.
Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA; ROCKET AF Investigators. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.
Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.
Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM; ROCKET AF Steering Committee and Investigators. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation. 2013 Jan 15;127(2):224-32. doi: 10.1161/CIRCULATIONAHA.112.107128. Epub 2012 Dec 3.
Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener HC, Donnan GA, Halperin JL, Mahaffey KW, Mas JL, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KA, Hacke W; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315-22. doi: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
39039039AFL3001
Identifier Type: OTHER
Identifier Source: secondary_id
ROCKET AF
Identifier Type: OTHER
Identifier Source: secondary_id
2006-004595-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR012157
Identifier Type: -
Identifier Source: org_study_id
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