Clinical trial NCT00496769: A Phase III Study of Apixaban in Patients With Atrial Fibrillation
Official title: Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2007-07-04
Enrollment: 6421
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Detailed description: An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase

Eligibility criteria: Key Inclusion Criteria:

* Male and female
* Age of 50 years or older
* Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
* At least 1 of the following risk factors for stroke:

  * Prior stroke or transient ischemic attack
  * Age of 75 years or older
  * Arterial hypertension on treatment
  * Diabetes mellitus
  * Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
  * Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
  * Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio \<0.9)
* Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

  * Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
  * Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

* Women who are pregnant or breast feeding
* Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
* Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
* Valvular disease requiring surgery
* Planned ablation procedure for atrial fibrillation to be performed within 3 months
* Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
* Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:

  * Active peptic ulcer disease
  * Platelet count \<100,000/mm\^3 or hemoglobin \<10g/dL
  * Recent stroke (within 10 days)
  * Documented hemorrhagic tendencies or blood dyscrasias
* Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
* Severe comorbid condition with life expectancy \<1 year
* Severe renal insufficiency; any patient with a serum creatinine level \>2.5 mg/dL or a calculated creatinine clearance \<25 mL/min is excluded
* Alanine transaminase or aspartate aminotransferase levels \>2 times upper limit of normal (ULN) or a total bilirubin level \>1.5 times ULN (unless an alternative causative factor \[such as Gilbert's syndrome\] is identified)
* Allergy or adverse reaction to acetylsalicylic acid
* Required treatment with a thienopyridine (clopidogrel or ticlopidine)
* Prisoners or participants who are compulsory detained (involuntarily incarcerated)
* Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
* Patients who are compulsorily detained for treatment for a psychiatric or physical illness

Primary outcomes:
measure: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
timeFrame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcomes:
measure: Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period
timeFrame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
measure: Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
timeFrame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
measure: Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
timeFrame: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
measure: Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
timeFrame: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
timeFrame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality
timeFrame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
timeFrame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)
timeFrame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Heart Specialists, Pc
state: Alabama
city: Tucson
country: United States
facility: Southwest Heart
state: Arizona
city: Anaheim
country: United States
facility: Cardiology Consultants Of Orange County Med. Group Inc
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center, West Los Angeles
state: California
city: Palm Springs
country: United States
facility: Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
state: California
city: Pomona
country: United States
facility: Yogesh K. Paliwal Md
state: California
city: Poway
country: United States
facility: San Diego Managed Care Group
state: California
city: San Diego
country: United States
facility: University Of California, San Diego
state: California
city: Santa Rosa
country: United States
facility: Santa Rosa Cardiology
state: California
city: Vista
country: United States
facility: North County Internal Medicine
state: California
city: Guilford
country: United States
facility: Cardiology Associates Of New Haven,Pc
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines Va Healthcare System
state: Florida
city: Clearwater
country: United States
facility: Research Alliance, Inc.
state: Florida
city: Clearwater
country: United States
facility: The Heart & Vascular Institute Of Florida
state: Florida
city: Daytona Beach
country: United States
facility: Kim A. Klancke, Md
state: Florida
city: Fort Myers
country: United States
facility: The Heart Group Pl
state: Florida
city: Jacksonville Beach
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent'S Ambulatory Care, Inc
state: Florida
city: Melbourne
country: United States
facility: Michael F. Lesser, Md, Facc Osler Medical Inc.
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center Of Sarasota
state: Florida
city: Tamarac
country: United States
facility: The Broward Heart Group, Pa
state: Florida
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, Llc
state: Illinois
city: North Chicago
country: United States
facility: North Chicago Va Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Heart Physicians, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: The Care Group, Llc
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic, Pa
state: Kansas
city: Lafayette
country: United States
facility: Dr. Jeffrey Chen
state: Louisiana
city: Salisbury
country: United States
facility: Peninsula Cardiology Associates, P.A.
state: Maryland
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Alpena
country: United States
facility: Great Lakes Heart Center Of Alpena
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital K-15
state: Michigan
city: Petoskey
country: United States
facility: Michigan Heart And Vascular Specialists
state: Michigan
city: Rochester Hills
country: United States
facility: Academic Cardiology Associates
state: Michigan
city: Tupelo
country: United States
facility: Tupelo Neurology Clinic, Pa
state: Mississippi
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Columbia
country: United States
facility: University Of Missouri
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Cardiology, Pc
state: Montana
city: Flemington
country: United States
facility: Hunterdon Cardiovascular Associates
state: New Jersey
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: Cortlandt Manor
country: United States
facility: Nyu Hudson Valley Cardiology
state: New York
city: Mineola
country: United States
facility: Long Island Heart Associates
state: New York
city: Saratoga Springs
country: United States
facility: Dr William Kufs
state: New York
city: Troy
country: United States
facility: Capital Cardiology Associates
state: New York
city: Lexington
country: United States
facility: Terry V. Arnold, Md
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic, Inc
state: North Carolina
city: Sanford
country: United States
facility: Sanford Cardiology
state: North Carolina
city: Canton
country: United States
facility: Ira R. Friedlander, M.D.
state: Ohio
city: Columbus
country: United States
facility: Davis Heart & Lung Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Cardiovascular Physicians
state: Oklahoma
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Medical Group - Clinical Research
state: Oregon
city: Hillsboro
country: United States
facility: Hillsboro Cardiology Pc
state: Oregon
city: Portland
country: United States
facility: The Portland Clinic, Llp
state: Oregon
city: Langhorne
country: United States
facility: Comprehensive Cardiology Consultants
state: Pennsylvania
city: Sellersville
country: United States
facility: Grand View - Lehigh Valley Health Services
state: Pennsylvania
city: West Chester
country: United States
facility: West Chester Cardiology
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants Of Philadelphia
state: Pennsylvania
city: Beaufort
country: United States
facility: Lowcountry Medical Group, Llc
state: South Carolina
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Internal Medicine Of Greer
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Heart Group
state: Tennessee
city: Norfolk
country: United States
facility: Sentara York Clinical Research
state: Virginia
city: Roanoke
country: United States
facility: Roanoke Heart Institute, Plc
state: Virginia
city: Salem
country: United States
facility: Salem Veterans Administration Medical Center
state: Virginia
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Adrogue
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Autonoma Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Bahia Blanca
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Coronel Suarez
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Haedo
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Merlo
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ramos Mejia
country: Argentina
facility: Local Institution
state: Buenos Aires
city: San Francisco
country: Argentina
facility: Local Institution
state: Cordoba
city: San Salvador De Jujuy
country: Argentina
facility: Local Institution
state: Jujuy
city: Zarate
country: Argentina
facility: Local Institution
state: Provincia Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: Rosario
country: Argentina
facility: Local Institution
state: Santa FE
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Corrientes
country: Argentina
facility: Local Institution
city: Salta
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Coffs Harbour
country: Australia
facility: Local Institution
state: New South Wales
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution
state: New South Wales
city: Kingswood
country: Australia
facility: Local Institution
state: New South Wales
city: Auchenflower
country: Australia
facility: Local Institution
state: Queensland
city: Kippa Ring
country: Australia
facility: Local Institution
state: Queensland
city: Milton
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Geelong
country: Australia
facility: Local Institution
state: Victoria
city: Joondalup
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Linz
country: Austria
facility: Local Institution
city: Oberpullendorf
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: Aalst
country: Belgium
facility: Local Institution
city: Brasschaat
country: Belgium
facility: Local Institution
city: Brussel
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: De Pinte
country: Belgium
facility: Local Institution
city: Genk
country: Belgium
facility: Local Institution
city: Huy
country: Belgium
facility: Local Institution
city: Roeselare
country: Belgium
facility: Local Institution
city: Turnhout
country: Belgium
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Belo Horizonte
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facility: Local Institution
state: Minas Gerais
city: Uberaba
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Uberaba
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Campina Grande Do Sul
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Maringa
country: Brazil
facility: Local Institution
state: Parana
city: Belem
country: Brazil
facility: Local Institution
state: Para
city: Natal
country: Brazil
facility: Local Institution
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Sao Jose
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Marilia
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Marilia
country: Brazil
facility: Local Institution
state: Sao Paulo
city: San Jose- Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
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facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: New Westminster
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Burlington
country: Canada
facility: Local Institution
state: Ontario
city: Cambridge
country: Canada
facility: Local Institution
state: Ontario
city: Cambridge
country: Canada
facility: Local Institution
state: Ontario
city: Grimsby
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Oshawa,
country: Canada
facility: Local Institution
state: Ontario
city: Oshawa
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Sarnia
country: Canada
facility: Local Institution
state: Ontario
city: Sudbury
country: Canada
facility: Local Institution
state: Ontario
city: Sudbury
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Weston
country: Canada
facility: Local Institution
state: Ontario
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Saint Georges Beauce
country: Canada
facility: Local Institution
state: Quebec
city: St. Jerome
country: Canada
facility: Local Institution
state: Quebec
city: St. Lambert
country: Canada
facility: Local Institution
state: Quebec
city: Terrebonne
country: Canada
facility: Local Institution
state: Quebec
city: Westmount
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Quebec
country: Canada
facility: Local Institution
city: Temuco
country: Chile
facility: Local Institution
state: Araucania
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state: Araucania
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facility: Local Institution
state: LOS Lagos
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facility: Local Institution
state: Los Rios
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facility: Local Institution
state: Metropolitana
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country: Chile
facility: Local Institution
state: Metropolitana
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facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
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facility: Local Institution
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facility: Local Institution
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facility: Local Institution
state: Beijing
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state: Hubei
city: Suzhou
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state: Jiangsu
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state: Shandong
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facility: Local Institution
state: Shanghai
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country: China
facility: Local Institution
state: Shanghai
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country: China
facility: Local Institution
state: Sichuan
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state: Antioquia
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facility: Local Institution
state: Santander
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country: Colombia
facility: Local Institution
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city: Havirov - Mesto
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city: Jindrichuv Hradec
country: Czechia
facility: Local Institution
city: Kladno
country: Czechia
facility: Local Institution
city: Kromeriz
country: Czechia
facility: Local Institution
city: Mestec Kralove
country: Czechia
facility: Local Institution
city: Ostrava
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facility: Local Institution
city: Pisek
country: Czechia
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country: Czechia
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Praha 5
country: Czechia
facility: Local Institution
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country: Czechia
facility: Local Institution
city: Pribram
country: Czechia
facility: Local Institution
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country: Czechia
facility: Local Institution
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facility: Local Institution
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country: Denmark
facility: Local Institution
city: Esbjerg
country: Denmark
facility: Local Institution
city: Frederiksberg
country: Denmark
facility: Local Institution
city: Espoo
country: Finland
facility: Local Institution
city: Helsinki
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facility: Local Institution
city: Jyvaskyla
country: Finland
facility: Local Institution
city: Kuopio
country: Finland
facility: Local Institution
city: Tampere
country: Finland
facility: Local Institution
city: Abbeville Cedex
country: France
facility: Local Institution
city: Albi Cedex 09
country: France
facility: Local Institution
city: Cholet
country: France
facility: Local Institution
city: Grenoble Cedex 09
country: France
facility: Local Institution
city: Langres Cedex
country: France
facility: Local Institution
city: Paris Cedex 18
country: France
facility: Local Institution
city: Sisteron
country: France
facility: Local Institution
city: Toulon Cedex 09
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt Am Main
country: Germany
facility: Local Institution
city: Halle/saale
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kassel
country: Germany
facility: Local Institution
city: Koln
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
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country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Papenburg
country: Germany
facility: Local Institution
city: Regensburg
country: Germany
facility: Local Institution
city: Riesa
country: Germany
facility: Local Institution
city: Witten
country: Germany
facility: Local Institution
city: Wolmirstedt
country: Germany
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city: Athens
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facility: Local Institution
city: Larissa
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facility: Local Institution
city: Thiva
country: Greece
facility: Local Institution
city: Shatin
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city: Hong Kong
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city: Mumbai
country: India
facility: Local Institution
state: Maharashtra
city: Mumbai
country: India
facility: Local Institution
state: Maharashtra
city: Nagpur,
country: India
facility: Local Institution
state: Maharashtra
city: Nashik
country: India
facility: Local Institution
state: Maharashtra
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Dhantoli
country: India
facility: Local Institution
state: Nagpur
city: Chennai
country: India
facility: Local Institution
state: Tamil Nadu
city: Lucknow
country: India
facility: Local Institution
state: Uttar Pradesh
city: Ahmedabad
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Bikaner
country: India
facility: Local Institution
city: Indore
country: India
facility: Local Institution
city: Jaipur
country: India
facility: Local Institution
city: Kottayam
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Malang
country: Indonesia
facility: Local Institution
state: Jawa-timur
city: Bandung
country: Indonesia
facility: Local Institution
city: Denpasar
country: Indonesia
facility: Local Institution
city: Jakarta Timur
country: Indonesia
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Padang
country: Indonesia
facility: Local Institution
city: Palembang
country: Indonesia
facility: Local Institution
city: Surabaya
country: Indonesia
facility: Local Institution
city: Yogyakarta
country: Indonesia
facility: Local Institution
city: Afula
country: Israel
facility: Local Institution
city: Ashkelon
country: Israel
facility: Local Institution
city: Givatayim
country: Israel
facility: Local Institution
city: Hadera
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Holon
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Nazareth
country: Israel
facility: Local Institution
city: Petach-tikva
country: Israel
facility: Local Institution
city: Safed
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Ascoli Piceno
country: Italy
facility: Local Institution
city: Chieti
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Isernia
country: Italy
facility: Local Institution
city: Lido Di Camaiore
country: Italy
facility: Local Institution
city: Palermo
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: San Daniele De Friuli (ud)
country: Italy
facility: Local Institution
city: Sassari
country: Italy
facility: Local Institution
city: Goyang-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Kuri-city
country: Korea, Republic of
facility: Local Institution
state: Kyunggi-do
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Gwangju
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Johor Bahru
country: Malaysia
facility: Local Institution
state: Johor
city: Cheras
country: Malaysia
facility: Local Institution
state: Kuala Lumpur
city: Pulau Pinang
country: Malaysia
facility: Local Institution
state: Pinang
city: Kuching
country: Malaysia
facility: Local Institution
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Atizapan De Zaragoza
country: Mexico
facility: Local Institution
state: Estado De Mexico
city: Acapulco
country: Mexico
facility: Local Institution
state: Guerrero
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: San Luis Potosi, Slp
country: Mexico
facility: Local Institution
state: San Luis Potosi
city: Culiacan
country: Mexico
facility: Local Institution
state: Sinaloa
city: Hermosillo
country: Mexico
facility: Local Institution
state: Sonora
city: Jalapa
country: Mexico
facility: Local Institution
state: Veracruz
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Chihuahua
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Queretaro
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Fyllingsdal
country: Norway
facility: Local Institution
city: Kongsberg
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Naga City
country: Philippines
facility: Local Institution
state: Camarines SUR
city: Binan
country: Philippines
facility: Local Institution
state: Laguna
city: Iligan City
country: Philippines
facility: Local Institution
state: Lanao DEL Norte
city: Cagayan De Oro City
country: Philippines
facility: Local Institution
city: Cavite
country: Philippines
facility: Local Institution
city: Laoag City
country: Philippines
facility: Local Institution
city: Manila
country: Philippines
facility: Local Institution
city: Muntinlupa City
country: Philippines
facility: Local Institution
city: Czestochowa
country: Poland
facility: Local Institution
city: Elblag
country: Poland
facility: Local Institution
city: Gdynia
country: Poland
facility: Local Institution
city: Gliwice
country: Poland
facility: Local Institution
city: Gniewkowo
country: Poland
facility: Local Institution
city: Grodzisk Mazowiecki
country: Poland
facility: Local Institution
city: Inowroclaw
country: Poland
facility: Local Institution
city: Kielce
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Piotrkow Trybunalski
country: Poland
facility: Local Institution
city: Plock
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Pulawy
country: Poland
facility: Local Institution
city: Siemianowice Slaskie
country: Poland
facility: Local Institution
city: Skierniewice
country: Poland
facility: Local Institution
city: Tarnow
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wegrow
country: Poland
facility: Local Institution
city: Zabrze
country: Poland
facility: Local Institution
city: Zarow
country: Poland
facility: Local Institution
city: Kaluga
country: Russian Federation
facility: Local Institution
state: Anenki
city: Barnaul
country: Russian Federation
facility: Local Institution
city: Chelyabinsk
country: Russian Federation
facility: Local Institution
city: Ekaterinburg
country: Russian Federation
facility: Local Institution
city: Ekaterinburg
country: Russian Federation
facility: Local Institution
city: Kazan
country: Russian Federation
facility: Local Institution
city: Kemerovo
country: Russian Federation
facility: Local Institution
city: Krasnodar
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: Perm
country: Russian Federation
facility: Local Institution
city: Perm
country: Russian Federation
facility: Local Institution
city: Ryazan
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint-petersburg
country: Russian Federation
facility: Local Institution
city: Saint-petersburg
country: Russian Federation
facility: Local Institution
city: Saint-petersburg
country: Russian Federation
facility: Local Institution
city: Saint-petersburg
country: Russian Federation
facility: Local Institution
city: Saint-petersburg
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: Tomsk
country: Russian Federation
facility: Local Institution
city: Tumen
country: Russian Federation
facility: Local Institution
city: Tver
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Bloemfontein
country: South Africa
facility: Local Institution
state: FREE State
city: Bloemfontein
country: South Africa
facility: Local Institution
state: FREE State
city: Alberton
country: South Africa
facility: Local Institution
state: Gauteng
city: Bellville, Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Somerset West
country: South Africa
facility: Local Institution
state: Western CAPE
city: Worcester
country: South Africa
facility: Local Institution
state: Western CAPE
city: Pretoria
country: South Africa
facility: Local Institution
city: Torrevieja
country: Spain
facility: Local Institution
state: Alicante
city: Hospitalet De Llobregat
country: Spain
facility: Local Institution
state: Barcelona
city: Lugo
country: Spain
facility: Local Institution
state: Galicia
city: Albacete
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Molndal
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Isparta
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
city: Kirikkale
country: Turkey
facility: Local Institution
city: Dnipropetrovsk
country: Ukraine
facility: Local Institution
city: Donetsk
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Aberdeen
country: United Kingdom
facility: Local Institution
state: Aberdeenshire
city: Chesterfield
country: United Kingdom
facility: Local Institution
state: Derbyshire
city: Basildon
country: United Kingdom
facility: Local Institution
state: Essex
city: Romford
country: United Kingdom
facility: Local Institution
state: Essex
city: Kirkcaldy
country: United Kingdom
facility: Local Institution
state: Fife
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Blackpool
country: United Kingdom
facility: Local Institution
state: Lancashire
city: Northampton
country: United Kingdom
facility: Local Institution
state: Northamptonshire
city: Worksop
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Craigavon
country: United Kingdom
facility: Local Institution
state: Portadown
city: Paisley
country: United Kingdom
facility: Local Institution
state: Renfrewshire
city: Barnsley
country: United Kingdom
facility: Local Institution
state: South Yorkshire
city: Larbert
country: United Kingdom
facility: Local Institution
state: Stirlingshire
city: Newcastle Upon
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Chichester
country: United Kingdom
facility: Local Institution
state: West Sussex
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
citation: Bhagirath VC, Eikelboom JW, Hirsh J, Coppens M, Ginsberg J, Vanassche T, Yuan F, Chan N, Yusuf S, Connolly SJ. Apixaban-Calibrated Anti-FXa Activity in Relation to Outcome Events and Clinical Characteristics in Patients with Atrial Fibrillation: Results from the AVERROES Trial. TH Open. 2017 Dec 12;1(2):e139-e145. doi: 10.1055/s-0037-1613679. eCollection 2017 Jul.
citation: Ng KH, Shestakovska O, Connolly SJ, Eikelboom JW, Avezum A, Diaz R, Lanas F, Yusuf S, Hart RG. Efficacy and safety of apixaban compared with aspirin in the elderly: a subgroup analysis from the AVERROES trial. Age Ageing. 2016 Jan;45(1):77-83. doi: 10.1093/ageing/afv156. Epub 2015 Nov 19.
citation: Hohnloser SH, Shestakovska O, Eikelboom J, Franzosi MG, Tan RS, Zhu J, Yusuf S, Connolly SJ. The effects of apixaban on hospitalizations in patients with different types of atrial fibrillation: insights from the AVERROES trial. Eur Heart J. 2013 Sep;34(35):2752-9. doi: 10.1093/eurheartj/eht292. Epub 2013 Jul 25.
citation: Lip GY, Connolly S, Yusuf S, Shestakovska O, Flaker G, Hart R, Lanas F, Xavier D, Eikelboom J; ERROES Investigators. Modification of outcomes with aspirin or apixaban in relation to CHADS(2) and CHA(2)DS(2)-VASc scores in patients with atrial fibrillation: a secondary analysis of the AVERROES study. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):31-8. doi: 10.1161/CIRCEP.112.975847. Epub 2013 Feb 6.
citation: Flaker GC, Eikelboom JW, Shestakovska O, Connolly SJ, Kaatz S, Budaj A, Husted S, Yusuf S, Lip GY, Hart RG. Bleeding during treatment with aspirin versus apixaban in patients with atrial fibrillation unsuitable for warfarin: the apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment (AVERROES) trial. Stroke. 2012 Dec;43(12):3291-7. doi: 10.1161/STROKEAHA.112.664144. Epub 2012 Oct 2.
citation: Diener HC, Eikelboom J, Connolly SJ, Joyner CD, Hart RG, Lip GY, O'Donnell M, Hohnloser SH, Hankey GJ, Shestakovska O, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial. Lancet Neurol. 2012 Mar;11(3):225-31. doi: 10.1016/S1474-4422(12)70017-0. Epub 2012 Feb 1.
citation: Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.