AzTrials
AzTrials

Atrial FibrillationPhase 3NCT00403767

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 Phase 3 study testing Rivaroxaban and Warfarin in people with Atrial Fibrillation and Stroke, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 932 sites in 44 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke, Embolism
What is being tested?
Rivaroxaban and Warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14,269 participants
Where
932 sitesin 44 countries
Study dates
Dec 2006to Sep 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

932 sites in 44 countries.

932 sites in 44 countries

United States295 sites

  • Study site

    Albany, Georgia

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anaconda, Montana

  • Study site

    Anaheim, California

  • Study site

    Anderson, Indiana

  • Study site

    Anderson, South Carolina

  • Study site

    Annapolis, Maryland

  • Study site

    Asheville, North Carolina

  • Study site

    Athens, Tennessee

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Aurora, Illinois

  • Study site

    Bakersfield, California

  • Study site

    Bangor, Maine

  • Study site

    Bannockburn, Illinois

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bay City, Michigan

  • Study site

    Beatrice, Nebraska

  • Study site

    Beaumont, Texas

  • Study site

    Beaver, Pennsylvania

  • Study site

    Bellingham, Washington

  • Study site

    Beltsville, Maryland

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Blacksburg, Virginia

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Boulder, Colorado

  • Study site

    Bradenton, Florida

  • Study site

    Bridgewater, New Jersey

  • Study site

    Bridgman, Michigan

  • Study site

    Brighton, Massachusetts

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Brownsville, Texas

  • Study site

    Buffalo, New York

  • Study site

    Burlington, Vermont

  • Study site

    Burlington, Wisconsin

  • Study site

    Canton, Ohio

  • Study site

    Carmichael, California

  • Study site

    Charleston, South Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chelsea, Michigan

  • Study site

    Chester, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Columbia, Maryland

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Corona, California

  • Study site

    Corpus Christi, Texas

  • Study site

    Cortlandt Manor, New York

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Daingerfield, Texas

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Danville, Pennsylvania

  • Study site

    Danville, Virginia

  • Study site

    Dayton, Ohio

  • Study site

    Daytona Beach, Florida

  • Study site

    Dearborn, Michigan

  • Study site

    DeBary, Florida

  • Study site

    Deerfield Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    DeSoto, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Dothan, Alabama

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    Easley, South Carolina

  • Study site

    East Syracuse, New York

  • Study site

    Edgewood, Kentucky

  • Study site

    Elkhorn, Wisconsin

  • Study site

    Elmer, New Jersey

  • Study site

    Evergreen Park, Illinois

  • Study site

    Fair Oaks, California

  • Study site

    Fairfax, Virginia

  • Study site

    Fairfield, Ohio

  • Study site

    Fargo, North Dakota

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Sam Houston, Texas

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Walton Beach, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Framingham, Massachusetts

  • Study site

    Fredericksburg, Virginia

  • Study site

    Fulton, Illinois

  • Study site

    Geneva, Alabama

  • Study site

    Glendale, Arizona

  • Study site

    Glendale, California

  • Study site

    Great Falls, Montana

  • Study site

    Greensboro, North Carolina

  • Study site

    Guilford, Connecticut

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hammond, Indiana

  • Study site

    Harriman, Tennessee

  • Study site

    Healdsburg, California

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Houma, Louisiana

  • Study site

    Houston, Texas

  • Study site

    Hudson, Florida

  • Study site

    Humble, Texas

  • Study site

    Hurst, Texas

  • Study site

    Idaho Falls, Idaho

  • Study site

    Indianapolis, Indiana

  • Study site

    Inverness, Florida

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jacksonville, North Carolina

  • Study site

    Jeannette, Pennsylvania

  • Study site

    Jersey Shore, Pennsylvania

  • Study site

    Johnson City, Tennessee

  • Study site

    Jupiter, Florida

  • Study site

    Kerrville, Texas

  • Study site

    Kingsport, Tennessee

  • Study site

    Kingwood, Texas

  • Study site

    Kissimmee, Florida

  • Study site

    Knoxville, Tennessee

  • Study site

    La Crosse, Wisconsin

  • Study site

    Laguna Hills, California

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Leetsdale, Pennsylvania

  • Study site

    Lewistown, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Lexington, Missouri

  • Study site

    Lexington, Tennessee

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Lombard, Illinois

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Los Gatos, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Lynchburg, Virginia

  • Study site

    Madisonville, Kentucky

  • Study site

    Manchester, New Hampshire

  • Study site

    Mansfield, Ohio

  • Study site

    Massillon, Ohio

  • Study site

    Maumee, Ohio

  • Study site

    McAllen, Texas

  • Study site

    Melbourne, Florida

  • Study site

    Melrose Park, Illinois

  • Study site

    Memphis, Tennessee

  • Study site

    Merrillville, Indiana

  • Study site

    Miami, Florida

  • Study site

    Miami Beach, Florida

  • Study site

    Midwest City, Oklahoma

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Minot, North Dakota

  • Study site

    Mission Viejo, California

  • Study site

    Mobile, Alabama

  • Study site

    Modesto, California

  • Study site

    Moline, Illinois

  • Study site

    Mount Clemens, Michigan

  • Study site

    Mount Sterling, Kentucky

  • Study site

    Mountain View, California

  • Study site

    Muncie, Indiana

  • Study site

    Munster, Indiana

  • Study site

    Murray, Utah

  • Study site

    Nampa, Idaho

  • Study site

    Nashville, Tennessee

  • Study site

    New Bern, North Carolina

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Norman, Oklahoma

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Wales, Pennsylvania

  • Study site

    Northport, New York

  • Study site

    Northridge, California

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orange Park, Florida

  • Study site

    Orlando, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Owensboro, Kentucky

  • Study site

    Pahrump, Nevada

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Palm Harbor, Florida

  • Study site

    Park Ridge, Illinois

  • Study site

    Paterson, New Jersey

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Pell City, Alabama

  • Study site

    Peoria, Illinois

  • Study site

    Petoskey, Michigan

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Philipsburg, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Phoenixville, Pennsylvania

  • Study site

    Picayune, Mississippi

  • Study site

    Pismo Beach, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Port Charlotte, Florida

  • Study site

    Port Orchard, Washington

  • Study site

    Portland, Oregon

  • Study site

    Pueblo, Colorado

  • Study site

    Quincy, Illinois

  • Study site

    Raleigh, North Carolina

  • Study site

    Rapid City, South Dakota

  • Study site

    Reidsville, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Ridgewood, New Jersey

  • Study site

    Roanoke, Virginia

  • Study site

    Rock Island, Illinois

  • Study site

    Rockford, Illinois

  • Study site

    Rocky Mount, North Carolina

  • Study site

    Sacramento, California

  • Study site

    Safety Harbor, Florida

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salisbury, Maryland

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Leandro, California

  • Study site

    Santa Clara, California

  • Study site

    Santa Monica, California

  • Study site

    Santa Rosa, California

  • Study site

    Saratoga Springs, New York

  • Study site

    Savannah, Georgia

  • Study site

    Sayre, Pennsylvania

  • Study site

    Scarborough, Maine

  • Study site

    Schenectady, New York

  • Study site

    Scottsdale, Arizona

  • Study site

    Scranton, Pennsylvania

  • Study site

    Seattle, Washington

  • Study site

    Sewell, New Jersey

  • Study site

    Shippensburg, Pennsylvania

  • Study site

    South Bend, Indiana

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Missouri

  • Study site

    Springfield, New Jersey

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    State College, Pennsylvania

  • Study site

    Staten Island, New York

  • Study site

    Statesville, North Carolina

  • Study site

    Stony Brook, New York

  • Study site

    Sugar Land, Texas

  • Study site

    Sumter, South Carolina

  • Study site

    Sylmar, California

  • Study site

    Syracuse, New York

  • Study site

    Tacoma, Washington

  • Study site

    Tallahassee, Florida

  • Study site

    Tamarac, Florida

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Thibodaux, Louisiana

  • Study site

    Toledo, Ohio

  • Study site

    Tomball, Texas

  • Study site

    Toms River, New Jersey

  • Study site

    Topton, Pennsylvania

  • Study site

    Torrance, California

  • Study site

    Traverse City, Michigan

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

  • Study site

    Vancouver, Washington

  • Study site

    Ventura, California

  • Study site

    Victoria, Texas

  • Study site

    Vidalia, Louisiana

  • Study site

    Virginia Beach, Virginia

  • Study site

    Waterloo, Iowa

  • Study site

    Watseka, Illinois

  • Study site

    Wausau, Wisconsin

  • Study site

    Wayne, New Jersey

  • Study site

    Westerly, Rhode Island

  • Study site

    Wilkes-Barre, Pennsylvania

  • Study site

    Williamsburg, Virginia

  • Study site

    Williamsville, New York

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Wormleysburg, Pennsylvania

  • Study site

    Wyomissing, Pennsylvania

  • Study site

    Yuba City, California

  • Study site

    Yukon, Oklahoma

  • Study site

    Zanesville, Ohio

Other trials in United States

Canada70 sites

  • Study site

    Abbotsford British Columbia, British Columbia

  • Study site

    Ajax, Ontario

  • Study site

    Beamsville, Ontario

  • Study site

    Belleville, Ontario

  • Study site

    Brampton, Ontario

  • Study site

    Burlington, Ontario

  • Study site

    Burnaby, British Columbia

  • Study site

    Calgary, Alberta

  • Study site

    Cambridge, Ontario

  • Study site

    Campbell River, British Columbia

  • Study site

    Chicoutimi, Quebec

  • Study site

    Corunna, Ontario

  • Study site

    Courtice, Ontario

  • Study site

    Delta, British Columbia

  • Study site

    E. London, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Etobicoke, Ontario

  • Study site

    Fort Erie, Ontario

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Greenfield Park, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Joliette, Quebec

  • Study site

    Jonquière, Quebec

  • Study site

    Kelowna, British Columbia

  • Study site

    Kitchener, Ontario

  • Study site

    Lachine, Quebec

  • Study site

    Langley, British Columbia

  • Study site

    Listowel, Ontario

  • Study site

    London, Ontario

  • Study site

    Longueuil, Quebec

  • Study site

    Markham, Ontario

  • Study site

    Mirabel, Quebec

  • Study site

    Mississauga, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    New Westminster, British Columbia

  • Study site

    North Battleford, Saskatchewan

  • Study site

    North Bay, Ontario

  • Study site

    North York, Ontario

  • Study site

    Oakville, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Parry Sound, Ontario

  • Study site

    Penticton, British Columbia

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Richmond Hill, Ontario

  • Study site

    Saint John, New Brunswick

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Saint-Lambert, Quebec

  • Study site

    Saint-Léonard, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Sault Ste. Marie, Ontario

  • Study site

    Scarborough Village, Ontario

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Strathroy, Ontario

  • Study site

    Sydney, Nova Scotia

  • Study site

    Thornhill, Ontario

  • Study site

    Thunder Bay, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

  • Study site

    Waterloo, Ontario

  • Study site

    West Vancouver, British Columbia

  • Study site

    Whitby, Ontario

  • Study site

    Winnipeg, Manitoba

  • Study site

    York, Ontario

Other trials in Canada

Germany62 sites

  • Study site

    Aalen

  • Study site

    Berlin

  • Study site

    Berlin/Spandau

  • Study site

    Biberach

  • Study site

    Bochum

  • Study site

    Bonn

  • Study site

    Chemnitz

  • Study site

    Coburg

  • Study site

    Dachau

  • Study site

    Dortmund

  • Study site

    Dresden

  • Study site

    Duisburg

  • Study site

    Ebersbach

  • Study site

    Eilenburg

  • Study site

    Erfurt

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Greifswald

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hartmannsdorf

  • Study site

    Heidelberg

  • Study site

    Henstedt-Rhen

  • Study site

    Herford

  • Study site

    Homburg/Saar

  • Study site

    Jena

  • Study site

    Jülich

  • Study site

    Kamen

  • Study site

    Karlsbad

  • Study site

    Kassel

  • Study site

    Kirchzarten

  • Study site

    Krefeld

  • Study site

    Leipzig

  • Study site

    Ludwigsburg

  • Study site

    Ludwigshafen

  • Study site

    Lüneburg

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Mannheim

  • Study site

    Markkleeberg

  • Study site

    Meißen

  • Study site

    Melsungen

  • Study site

    Mönchengladbach

  • Study site

    Mühldorf

  • Study site

    Mülheim

  • Study site

    München

  • Study site

    Münster

  • Study site

    Neuwied

  • Study site

    Nienburg

  • Study site

    Nuremberg

  • Study site

    Paderborn

  • Study site

    Potsdam

  • Study site

    Riesa

  • Study site

    Rottweil

  • Study site

    Sachsen

  • Study site

    Siegen

  • Study site

    Ulm

  • Study site

    Wermsdorf

  • Study site

    Witten

  • Study site

    Wolmirstedt

  • Study site

    Wuppertal

Other trials in Germany

Australia30 sites

  • Study site

    Adelaide

  • Study site

    Auchenflower

  • Study site

    Bedford Park

  • Study site

    Box Hill

  • Study site

    Caboolture

  • Study site

    Cairns

  • Study site

    Camperdown

  • Study site

    Chermside

  • Study site

    Clayton

  • Study site

    Coffs Harbour

  • Study site

    Footscray

  • Study site

    Garran

  • Study site

    Geelong

  • Study site

    Gosford

  • Study site

    Heidelberg Heights

  • Study site

    Herston

  • Study site

    Hobart

  • Study site

    Joondalup

  • Study site

    Lismore

  • Study site

    Liverpool

  • Study site

    Miranda

  • Study site

    Nedlands

  • Study site

    New Lambton Heights

  • Study site

    Parkville

  • Study site

    Penrith

  • Study site

    Prahran

  • Study site

    Reservoir

  • Study site

    Southport

  • Study site

    Windsor

  • Study site

    Wolloongabba

Other trials in Australia

Poland25 sites

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Gdynia

  • Study site

    Katowice

  • Study site

    Katowice-Ochojec

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Oława

  • Study site

    Olsztyn

  • Study site

    Opole

  • Study site

    Ostrowiec

  • Study site

    Piotrkow Trybunalski

  • Study site

    Płock

  • Study site

    Poznan

  • Study site

    Siedlce

  • Study site

    Sieradz

  • Study site

    Skierniewice

  • Study site

    Starogard Gdanski Nap

  • Study site

    Szczecin

  • Study site

    Szczecin Nap

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Włocławek

  • Study site

    Wroclaw

  • Study site

    Żyrardów

Other trials in Poland

United Kingdom25 sites

  • Study site

    Aberdeen

  • Study site

    Belfast

  • Study site

    Birmingham

  • Study site

    Bournemouth

  • Study site

    Cambridgeshire

  • Study site

    Chelmsford

  • Study site

    Chesterfield

  • Study site

    Colchester

  • Study site

    Craigavon

  • Study site

    Devon

  • Study site

    Dundee

  • Study site

    Glasgow

  • Study site

    Harrogate

  • Study site

    Hull

  • Study site

    Leicester

  • Study site

    Lincoln

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Nottingham

  • Study site

    Plymouth

  • Study site

    Romford

  • Study site

    Sheffield

  • Study site

    Stirling

  • Study site

    Stoke-on-Trent

  • Study site

    York

Other trials in United Kingdom

France24 sites

  • Study site

    Albi

  • Study site

    Arras

  • Study site

    Bayonne

  • Study site

    Belfort

  • Study site

    Besançon

  • Study site

    Béziers Languedoc-Roussillon

  • Study site

    Bourg-en-Bresse

  • Study site

    Brest

  • Study site

    Carcassonne

  • Study site

    Clermont-Ferrand

  • Study site

    Corbeil-Essonnes

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Montbéliard

  • Study site

    Montpellier

  • Study site

    Paris

  • Study site

    Perpignan

  • Study site

    Poitiers

  • Study site

    Saint-Brieuc

  • Study site

    Saint-Jean-de-Verges

  • Study site

    Strasbourg

  • Study site

    Thionville

  • Study site

    Toulouse

  • Study site

    Trélivan

Other trials in France

Brazil23 sites

  • Study site

    Belo Horizonte

  • Study site

    Blumenau

  • Study site

    Brasília

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Campo Grande

  • Study site

    Curitiba

  • Study site

    Fortaleza

  • Study site

    Goiânia

  • Study site

    Maceió

  • Study site

    Marília

  • Study site

    Maringá

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    Rio de Janeiro

  • Study site

    Rio de Janeiro Br

  • Study site

    Salvador

  • Study site

    Santo André

  • Study site

    São Caetano do Sul

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

  • Study site

    Sorocaba

  • Study site

    Uberlândia

Other trials in Brazil

Ukraine22 sites

  • Study site

    Cherkassy

  • Study site

    Chernihiv

  • Study site

    Dnipro

  • Study site

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About this study

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

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).

Read the 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.

Being tested
Rivaroxaban, Warfarin, Matching placebo for Rivaroxaban arm (Warfarin placebo), Matching placebo for Warfarin arm (Rivaroxaban placebo)
Keywords
Atrial Fibrillation, Stroke, Embolism, Non-central nervous system systemic embolism, Non-valvular atrial fibrillation, Blood Clot, Rivaroxaban, Warfarin, Anticoagulants, Arrhythmias, Cardiac
Medical subject headings
Atrial Fibrillation, Stroke, Embolism, Thrombosis, Arrhythmias, Cardiac

What participants receive

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

  • RivaroxabanDrug

    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)

  • WarfarinDrug

    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)Drug

    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)Drug

    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

Study groups in NCT00403767
Study groupRoleWhat they receive
RivaroxabanExperimentalNot described
Receives: Drug: Rivaroxaban; Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)
WarfarinActive comparatorNot described
Receives: Drug: Warfarin; Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)

What is being measured

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

  1. The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)

    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.

    Measured: Up to 4 years

  2. The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)

    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.

    Measured: Up to 4 years

  3. The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety

    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.

    Measured: Up to 4 years

Secondary outcomes (7)

  1. The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death

    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.

    Measured: Up to 4 years

  2. The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death

    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.

    Measured: Up to 4 years

  3. The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke

    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.

    Measured: Up to 4 years

  4. The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism

    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.

    Measured: Up to 4 years

  5. The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction

    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.

    Measured: Up to 4 years

  6. The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death

    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.

    Measured: Up to 4 years

  7. All-cause Mortality

    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.

    Measured: Up to 4 years

Timeline

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

  1. First posted27 Nov 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14,269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403767
Sponsor's protocol ID
CR012157
Other IDs
39039039AFL3001, ROCKET AF, 2006-004595-13
Status last verified
Apr 2014
First submitted
23 Nov 2006
Last updated
29 Apr 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40163217

  • 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.

    PubMed 31376090

  • 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.

    PubMed 30371223

  • 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.

    PubMed 30219887

  • 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.

    PubMed 29898836

  • 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.

    PubMed 28615214

  • 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.

    PubMed 28477860

  • 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.

    PubMed 28433206

  • 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.

    PubMed 28264892

  • 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.

    PubMed 27358435

  • 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.

    PubMed 26955859

  • 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.

    PubMed 26888572

  • 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.

    PubMed 26673560

  • 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.

    PubMed 26386791

  • 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.

    PubMed 25749644

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban and Warfarin in people with Atrial Fibrillation and Stroke, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 932 sites in 44 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 932 sites in United States, Canada, Germany, Australia, Poland and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00403767, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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