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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403767
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : July 17, 2012
Last Update Posted : April 29, 2014
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Embolism Drug: Rivaroxaban Drug: Warfarin Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo) Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo) Phase 3

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  (Clinical Trial)
Actual Enrollment : 14269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rivaroxaban 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: 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

Active Comparator: Warfarin 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 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

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Information from the National Library of Medicine

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

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403767

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
Dothan, Alabama, United States
Geneva, Alabama, United States
Mobile, Alabama, United States
Pell City, Alabama, United States
United States, Arizona
Glendale, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
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
United States, Colorado
Boulder, Colorado, United States
Denver, Colorado, United States
Littleton, Colorado, United States
Pueblo, Colorado, United States
United States, Connecticut
Danbury, Connecticut, United States
Guilford, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
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 Beach, Florida, United States
Miami, 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
United States, Georgia
Albany, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
United States, Idaho
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, United States
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
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
United States, Iowa
Waterloo, Iowa, United States
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
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
United States, Maine
Bangor, Maine, United States
Scarborough, Maine, United States
United States, Maryland
Annapolis, Maryland, United States
Beltsville, Maryland, United States
Columbia, Maryland, United States
Salisbury, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Brighton, Massachusetts, United States
Framingham, Massachusetts, United States
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
United States, Minnesota
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
United States, Mississippi
Picayune, Mississippi, United States
Tupelo, Mississippi, United States
United States, Missouri
Lexington, Missouri, United States
Saint Louis, Missouri, United States
Springfield, Missouri, United States
United States, Montana
Anaconda, Montana, United States
Great Falls, Montana, United States
United States, Nebraska
Beatrice, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
United States, New Hampshire
Manchester, New Hampshire, United States
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
United States, New Mexico
Albuquerque, New Mexico, United States
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
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
United States, North Dakota
Fargo, North Dakota, United States
Minot, North Dakota, United States
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
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
United States, Oregon
Portland, Oregon, United States
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
United States, Rhode Island
Pawtucket, Rhode Island, United States
Westerly, Rhode Island, United States
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
United States, South Dakota
Rapid City, South Dakota, United States
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
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
United States, Utah
Murray, Utah, United States
Salt Lake City, Utah, United States
United States, Vermont
Burlington, Vermont, United States
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
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
United States, Wisconsin
Burlington, Wisconsin, United States
Elkhorn, Wisconsin, United States
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Wausau, Wisconsin, United States
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 N/A, Austria
Wien Wien, Austria
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 Br, Brazil
Rio De Janeiro, 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
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
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
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Moncton, New Brunswick, Canada
Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
St. John'S, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Sydney, Nova Scotia, Canada
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
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
Canada, Saskatchewan
North Battleford, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Quebec, 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 Atlántico Atlanti, Colombia
Barranquilla, 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
Medellin, Colombia
Santander, Colombia
Czech Republic
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 10 N/A, Czech Republic
Praha 1, Czech Republic
Praha 2, Czech Republic
Praha 4, Czech Republic
Praha 5, Czech Republic
Praha 8, Czech Republic
Praha, Czech Republic
Slany, Czech Republic
Svitavy 2, Czech Republic
Svitavy, 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 Cedex 14, France
Paris, France
Perpignan, France
Poitiers, France
Saint-Brieuc, France
St Jean De Verges, France
Strasbourg, France
Thionville, France
Toulouse, France
Trelivan, France
Aalen, Germany
Berlin/Spandau, Germany
Berlin, 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
Hong Kong
Aberdeen, Hong Kong
Hk, Hong Kong
Kln, Hong Kong
Sha Tin, Hong Kong
Budapest N/A, Hungary
Budapest Nap, Hungary
Budapest, 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 Andra Pradesh, India
Hyderabad, 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
Korea, Republic of
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 Nuevo Leòn, Mexico
Monterrey, 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
New Zealand
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 1 Lima Lima, Peru
Lima, Peru
Cebuu City, Philippines
Davao City, Philippines
Iloilo City, Philippines
Manila City, Philippines
Quezon City, Philippines
Bydgoszcz N/A, Poland
Bydgoszcz, Poland
Gdansk, Poland
Gdynia, Poland
Katowice-Ochojec, Poland
Katowice, 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 Nap, Poland
Szczecin, Poland
Torun, Poland
Warsaw, Poland
Warszawa N/A, Poland
Warszawa, Poland
Wloclawek, Poland
Wroclaw N/A, Poland
Wroclaw, 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
Russian Federation
Barnaul, Russian Federation
Chelyabinsk Chelyabinsk Region, Russian Federation
Chelyabinsk, Russian Federation
Ekaterinburg, Russian Federation
Kemerovo, Russian Federation
Krasnoyarsk, Russian Federation
Moscow N/A, Russian Federation
Moscow, Russian Federation
Nizhni Novgorod, Russian Federation
Novosibirsk Nap, Russian Federation
Novosibirsk, 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 Nap, Russian Federation
Yaroslavl, Russian Federation
Singapore, Singapore
South Africa
Bloemfontein Free State, South Africa
Bloemfontein Orange Free State, South Africa
Cape Town Western Cape, South Africa
Cape Town, 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 Noi, Thailand
Bangkok, 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
United Kingdom
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
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier: NCT00403767     History of Changes
Other Study ID Numbers: CR012157
39039039AFL3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
ROCKET AF ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2006-004595-13 ( EudraCT Number )
First Posted: November 27, 2006    Key Record Dates
Results First Posted: July 17, 2012
Last Update Posted: April 29, 2014
Last Verified: April 2014

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Atrial Fibrillation
Non-central nervous system systemic embolism
Non-valvular atrial fibrillation
Blood Clot
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action