A Phase III Study of Apixaban in Patients With Atrial Fibrillation
NCT ID: NCT00496769
Last Updated: 2018-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6421 participants
INTERVENTIONAL
2007-08-31
2017-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Apixaban
Apixaban
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
Acetylasalicylic acid
Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks
Interventions
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Apixaban
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
Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Mobile Heart Specialists, Pc
Mobile, Alabama, United States
Southwest Heart
Tucson, Arizona, United States
Cardiology Consultants Of Orange County Med. Group Inc
Anaheim, California, United States
Kaiser Permanente Medical Center, West Los Angeles
Los Angeles, California, United States
Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
Palm Springs, California, United States
Yogesh K. Paliwal Md
Pomona, California, United States
San Diego Managed Care Group
Poway, California, United States
University Of California, San Diego
San Diego, California, United States
Santa Rosa Cardiology
Santa Rosa, California, United States
North County Internal Medicine
Vista, California, United States
Cardiology Associates Of New Haven,Pc
Guilford, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Bay Pines Va Healthcare System
Bay Pines, Florida, United States
Research Alliance, Inc.
Clearwater, Florida, United States
The Heart & Vascular Institute Of Florida
Clearwater, Florida, United States
Kim A. Klancke, Md
Daytona Beach, Florida, United States
The Heart Group Pl
Fort Myers, Florida, United States
St. Vincent'S Ambulatory Care, Inc
Jacksonville, Florida, United States
Baptist Heart Specialists
Jacksonville Beach, Florida, United States
Michael F. Lesser, Md, Facc Osler Medical Inc.
Melbourne, Florida, United States
Cardiovascular Center Of Sarasota
Sarasota, Florida, United States
The Broward Heart Group, Pa
Tamarac, Florida, United States
Southeast Regional Research Group
Columbus, Georgia, United States
Southeast Regional Research Group
Savannah, Georgia, United States
Fox Valley Clinical Research Center, Llc
Aurora, Illinois, United States
North Chicago Va Medical Center
North Chicago, Illinois, United States
Indiana Heart Physicians, Inc.
Indianapolis, Indiana, United States
The Care Group, Llc
Indianapolis, Indiana, United States
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States
Dr. Jeffrey Chen
Lafayette, Louisiana, United States
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, United States
Pentucket Medical Associates
Haverhill, Massachusetts, United States
Great Lakes Heart Center Of Alpena
Alpena, Michigan, United States
Henry Ford Hospital K-15
Detroit, Michigan, United States
Michigan Heart And Vascular Specialists
Petoskey, Michigan, United States
Academic Cardiology Associates
Rochester Hills, Michigan, United States
Tupelo Neurology Clinic, Pa
Tupelo, Mississippi, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, United States
University Of Missouri
Columbia, Missouri, United States
Glacier View Cardiology, Pc
Kalispell, Montana, United States
Hunterdon Cardiovascular Associates
Flemington, New Jersey, United States
Capital Cardiology Associates
Albany, New York, United States
Nyu Hudson Valley Cardiology
Cortlandt Manor, New York, United States
Long Island Heart Associates
Mineola, New York, United States
Dr William Kufs
Saratoga Springs, New York, United States
Capital Cardiology Associates
Troy, New York, United States
Terry V. Arnold, Md
Lexington, North Carolina, United States
Pinehurst Medical Clinic, Inc
Pinehurst, North Carolina, United States
Sanford Cardiology
Sanford, North Carolina, United States
Ira R. Friedlander, M.D.
Canton, Ohio, United States
Davis Heart & Lung Research Institute
Columbus, Ohio, United States
Integris Cardiovascular Physicians
Oklahoma City, Oklahoma, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Oregon Medical Group - Clinical Research
Eugene, Oregon, United States
Hillsboro Cardiology Pc
Hillsboro, Oregon, United States
The Portland Clinic, Llp
Portland, Oregon, United States
Comprehensive Cardiology Consultants
Langhorne, Pennsylvania, United States
Grand View - Lehigh Valley Health Services
Sellersville, Pennsylvania, United States
West Chester Cardiology
West Chester, Pennsylvania, United States
Cardiology Consultants Of Philadelphia
Yardley, Pennsylvania, United States
Lowcountry Medical Group, Llc
Beaufort, South Carolina, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Internal Medicine Of Greer
Greer, South Carolina, United States
Knoxville Heart Group
Knoxville, Tennessee, United States
Sentara York Clinical Research
Norfolk, Virginia, United States
Roanoke Heart Institute, Plc
Roanoke, Virginia, United States
Salem Veterans Administration Medical Center
Salem, Virginia, United States
Walla Walla Clinic
Walla Walla, Washington, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Isparta, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kırıkkale, , Turkey (Türkiye)
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Aberdeen, Aberdeenshire, United Kingdom
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Chesterfield, Derbyshire, United Kingdom
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Basildon, Essex, United Kingdom
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Romford, Essex, United Kingdom
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Kirkcaldy, Fife, United Kingdom
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London, Greater London, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Northampton, Northamptonshire, United Kingdom
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Worksop, Nottinghamshire, United Kingdom
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Craigavon, Portadown, United Kingdom
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Paisley, Renfrewshire, United Kingdom
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Barnsley, South Yorkshire, United Kingdom
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Larbert, Stirlingshire, United Kingdom
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Newcastle Upon, Tyne and Wear, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Chichester, West Sussex, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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Other Identifiers
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CV185-048
Identifier Type: -
Identifier Source: org_study_id
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