A Phase III Study of Apixaban in Patients With Atrial Fibrillation
AVERROES
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
1 other identifier
interventional
6,421
35 countries
493
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Aug 2007
Longer than P75 for phase_3 atrial-fibrillation
493 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedStudy Start
First participant enrolled
August 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2010
CompletedResults Posted
Study results publicly available
November 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2017
CompletedJune 15, 2018
May 1, 2018
3.3 years
July 2, 2007
August 1, 2013
May 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary Outcomes (8)
Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
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
Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
- +3 more secondary outcomes
Study Arms (2)
Apixaban
EXPERIMENTALAcetylasalicylic acid
ACTIVE COMPARATORInterventions
Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (503)
Mobile Heart Specialists, Pc
Mobile, Alabama, 36608, United States
Southwest Heart
Tucson, Arizona, 85710, United States
Cardiology Consultants Of Orange County Med. Group Inc
Anaheim, California, 92801, United States
Kaiser Permanente Medical Center, West Los Angeles
Los Angeles, California, 90034, United States
Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
Palm Springs, California, 92262, United States
Yogesh K. Paliwal Md
Pomona, California, 91767, United States
San Diego Managed Care Group
Poway, California, 92064, United States
University Of California, San Diego
San Diego, California, 92103, United States
Santa Rosa Cardiology
Santa Rosa, California, 95405, United States
North County Internal Medicine
Vista, California, 92083, United States
Cardiology Associates Of New Haven,Pc
Guilford, Connecticut, 06437, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Bay Pines Va Healthcare System
Bay Pines, Florida, 33744, United States
Research Alliance, Inc.
Clearwater, Florida, 33756, United States
The Heart & Vascular Institute Of Florida
Clearwater, Florida, 33756, United States
Kim A. Klancke, Md
Daytona Beach, Florida, 32114, United States
The Heart Group Pl
Fort Myers, Florida, 33908, United States
St. Vincent'S Ambulatory Care, Inc
Jacksonville, Florida, 32204, United States
Baptist Heart Specialists
Jacksonville Beach, Florida, 32250, United States
Michael F. Lesser, Md, Facc Osler Medical Inc.
Melbourne, Florida, 32901, United States
Cardiovascular Center Of Sarasota
Sarasota, Florida, 34239, United States
The Broward Heart Group, Pa
Tamarac, Florida, 33321, United States
Southeast Regional Research Group
Columbus, Georgia, 31904, United States
Southeast Regional Research Group
Savannah, Georgia, 31406, United States
Fox Valley Clinical Research Center, Llc
Aurora, Illinois, 60504, United States
North Chicago Va Medical Center
North Chicago, Illinois, 60064, United States
Indiana Heart Physicians, Inc.
Indianapolis, Indiana, 46237, United States
The Care Group, Llc
Indianapolis, Indiana, 46290, United States
Hutchinson Clinic, Pa
Hutchinson, Kansas, 67502, United States
Dr. Jeffrey Chen
Lafayette, Louisiana, 70506, United States
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, 21804, United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01830, United States
Great Lakes Heart Center Of Alpena
Alpena, Michigan, 49707, United States
Henry Ford Hospital K-15
Detroit, Michigan, 48202, United States
Michigan Heart And Vascular Specialists
Petoskey, Michigan, 49770, United States
Academic Cardiology Associates
Rochester Hills, Michigan, 48307, United States
Tupelo Neurology Clinic, Pa
Tupelo, Mississippi, 38801, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201, United States
University Of Missouri
Columbia, Missouri, 65212, United States
Glacier View Cardiology, Pc
Kalispell, Montana, 59901, United States
Hunterdon Cardiovascular Associates
Flemington, New Jersey, 08822, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
Nyu Hudson Valley Cardiology
Cortlandt Manor, New York, 10567, United States
Long Island Heart Associates
Mineola, New York, 11501, United States
Dr William Kufs
Saratoga Springs, New York, 12866, United States
Capital Cardiology Associates
Troy, New York, 12180, United States
Terry V. Arnold, Md
Lexington, North Carolina, 27293, United States
Pinehurst Medical Clinic, Inc
Pinehurst, North Carolina, 28374, United States
Sanford Cardiology
Sanford, North Carolina, 27330, United States
Ira R. Friedlander, M.D.
Canton, Ohio, 44710, United States
Davis Heart & Lung Research Institute
Columbus, Ohio, 43210, United States
Integris Cardiovascular Physicians
Oklahoma City, Oklahoma, 73112, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
Oregon Medical Group - Clinical Research
Eugene, Oregon, 97401, United States
Hillsboro Cardiology Pc
Hillsboro, Oregon, 97123, United States
The Portland Clinic, Llp
Portland, Oregon, 97205, United States
Comprehensive Cardiology Consultants
Langhorne, Pennsylvania, 19047, United States
Grand View - Lehigh Valley Health Services
Sellersville, Pennsylvania, 18960, United States
West Chester Cardiology
West Chester, Pennsylvania, 19380, United States
Cardiology Consultants Of Philadelphia
Yardley, Pennsylvania, 19067, United States
Lowcountry Medical Group, Llc
Beaufort, South Carolina, 29906, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Internal Medicine Of Greer
Greer, South Carolina, 29650, United States
Knoxville Heart Group
Knoxville, Tennessee, 37916, United States
Sentara York Clinical Research
Norfolk, Virginia, 23510, United States
Roanoke Heart Institute, Plc
Roanoke, Virginia, 24014, United States
Salem Veterans Administration Medical Center
Salem, Virginia, 24153, United States
Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
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Piotrkow Trybunalski, 97-300, Poland
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Poznan, 60-539, Poland
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Puławy, 24-100, Poland
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Płock, 09-402, Poland
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Siemianowice Śląskie, 41-100, Poland
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Skierniewice, 96-100, Poland
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Tarnów, 33-100, Poland
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Warsaw, 00-217, Poland
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Warsaw, 03-242, Poland
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Warsaw, 04-073, Poland
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Węgrów, 07-100, Poland
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Zabrze, 41-800, Poland
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Żarów, 58-130, Poland
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Kaluga, Anenki, 248007, Russia
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Barnaul, 656055, Russia
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Chelyabinsk, 454136, Russia
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Kazan', 420012, Russia
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Kemerovo, 650002, Russia
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Krasnodar, 350042, Russia
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Moscow, 101990, Russia
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Moscow, 105066, Russia
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Moscow, 109240, Russia
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Moscow, 111539, Russia
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Moscow, 117485, Russia
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Moscow, 119121, Russia
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Moscow, 121356, Russia
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Moscow, 121552, Russia
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Moscow, 125284, Russia
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Moscow, 125367, Russia
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Moscow, 127644, Russia
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Moscow, 129301, Russia
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Moscow, 129336, Russia
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Moscow, 143000, Russia
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Nizhny Novgorod, 603035, Russia
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Novosibirsk, 630047, Russia
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Perm, 614097, Russia
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Perm, 614107, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 190000, Russia
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Saint Petersburg, 191025, Russia
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Saint Petersburg, 193079, Russia
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Saint Petersburg, 193144, Russia
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Saint Petersburg, 194156, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 195112, Russia
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Saint Petersburg, 197198, Russia
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Samara, 443070, Russia
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Samara, 443095, Russia
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Saratov, 410028, Russia
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Saratov, 410054, Russia
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Tomsk, 634012, Russia
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Tver', 170036, Russia
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Tyumen, 625023, Russia
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Yaroslavl, 150062, Russia
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Yekaterinburg, 620109, Russia
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Yekaterinburg, 620144, Russia
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Singapore, 169609, Singapore
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Singapore, 308433, Singapore
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Singapore, 529889, Singapore
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Singapore, 768828, Singapore
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Bloemfontein, Free State, 9300, South Africa
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Bloemfontein, Free State, 9301, South Africa
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Alberton, Gauteng, 1450, South Africa
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Bellville, Cape Town, Western Cape, 7530, South Africa
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Cape Town, Western Cape, 7925, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Worcester, Western Cape, 6850, South Africa
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Pretoria, 0041, South Africa
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Goyang-si, Gyeonggi-do, 411-773, South Korea
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Guri-si, Gyeonggi-do, 471-701, South Korea
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Seongnam-si, Gyeonggi-do, 463-707, South Korea
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Busan, 602-702, South Korea
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Daegu, 700-721, South Korea
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Daejeon, 302-718, South Korea
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Gwangju, 501-757, South Korea
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Seoul, 110-744, South Korea
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Seoul, 130-709, South Korea
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Seoul, 143-729, South Korea
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Torrevieja, Alicante, 03186, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Lugo, Galicia, 27003, Spain
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Albacete, 02006, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Valencia, 46017, Spain
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Gothenburg, 416 85, Sweden
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Gothenburg, 417 17, Sweden
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Mölndal, 431 80, Sweden
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Stockholm, 111 57, Sweden
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Stockholm, 118 83, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 751 85, Sweden
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Kaohsiung City, 807, Taiwan
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Taichung, 402, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10507, Taiwan
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Taipei, 111, Taiwan
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Taipei, 220, Taiwan
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Isparta, 32100, Turkey (Türkiye)
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Istanbul, 34304, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Kırıkkale, 71100, Turkey (Türkiye)
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Dnipropetrovsk, 49005, Ukraine
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Donetsk, 83114, Ukraine
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Kharkiv, 61002, Ukraine
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Kharkiv, 61018, Ukraine
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Kharkiv, 61029, Ukraine
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Kharkiv, 61115, Ukraine
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Kharkiv, 61176, Ukraine
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Kyiv, 01023, Ukraine
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Kyiv, 02091, Ukraine
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Kyiv, 02660, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04107, Ukraine
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Kyiv, 04114, Ukraine
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Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
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Chesterfield, Derbyshire, S44 5BL, United Kingdom
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Basildon, Essex, SS16 5NL, United Kingdom
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Romford, Essex, RM7 0AG, United Kingdom
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Kirkcaldy, Fife, KY2 5AH, United Kingdom
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London, Greater London, SW17 ORE, United Kingdom
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Glasgow, Lanarkshire, G11 6NT, United Kingdom
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Glasgow, Lanarkshire, G51 4TF, United Kingdom
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Blackpool, Lancashire, FY3 8NR, United Kingdom
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Northampton, Northamptonshire, NN1 5BD, United Kingdom
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Worksop, Nottinghamshire, S18 0BD, United Kingdom
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Craigavon, Portadown, BT63 5QQ, United Kingdom
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Paisley, Renfrewshire, PA2 9PN, United Kingdom
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Barnsley, South Yorkshire, S75 2EP, United Kingdom
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Larbert, Stirlingshire, FK5 4WR, United Kingdom
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Newcastle Upon, Tyne and Wear, NE2 4HH, United Kingdom
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Birmingham, West Midlands, B18 7QH, United Kingdom
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Chichester, West Sussex, PO19 6SE, United Kingdom
Related Publications (9)
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.
PMID: 35570249DERIVEDNatale 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.
PMID: 35224730DERIVEDBhagirath 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.
PMID: 31249919DERIVEDNg 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.
PMID: 26590293DERIVEDHohnloser 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.
PMID: 23892201DERIVEDLip 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.
PMID: 23390125DERIVEDFlaker 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.
PMID: 23033347DERIVEDDiener 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.
PMID: 22305462DERIVEDConnolly 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.
PMID: 21309657DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
On May 28, 2010, after a planned interim analysis for efficacy, the Data Monitoring Committee recommended early termination due to apixaban's superior efficacy over ASA, with an acceptable safety profile. The open-label phase is ongoing.
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 4, 2007
Study Start
August 31, 2007
Primary Completion
November 30, 2010
Study Completion
May 25, 2017
Last Updated
June 15, 2018
Results First Posted
November 14, 2013
Record last verified: 2018-05