Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation
NCT ID: NCT01938248
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
4012 participants
INTERVENTIONAL
2015-05-31
2023-11-03
Brief Summary
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Detailed Description
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Apixaban is a Factor Xa inhibitor that is an effective and safe anticoagulant. It has been shown to have an excellent risk benefit profile for stroke prevention in clinical AF (14, 15). It is highly suitable to test if oral anticoagulation therapy will reduce the risk of stroke or systemic embolism in SCAF.
Patients will be randomized double-blind to receive apixaban or aspirin. Apixaban dose will be 5 mg twice daily (2.5 mg twice daily if 2 or more of: age \> 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L). Those assigned to aspirin will receive a dose of 81 mg daily. The study will be event driven and will continue until 248 patients have experienced a primary outcome event.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control
Aspirin 81 mg once daily
aspirin
aspirin 81 mg once daily
Intervention
Apixaban, 5 mg twice daily (or 2.5 mg twice daily if 2 or more of: age \> 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
Apixaban
apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age \> 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
Interventions
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Apixaban
apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age \> 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
aspirin
aspirin 81 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one episode of SCAF ≥ 6 minutes in duration but no single episode \> 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average \> 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration.
3. Age ≥ 55 years
4. Risk Factor(s) for Stroke:
Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors
Other risk factors are:
* hypertension
* CHF
* diabetes
* vascular disease (i.e. CAD, PAD or Aortic Plaque)
* female
Exclusion Criteria
2. Mechanical valve prosthesis, deep vein thrombosis, recent pulmonary embolism or other condition requiring treatment with an anticoagulant
3. Contra-indication to apixaban or aspirin:
1. Allergy to aspirin or apixaban
2. Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with either a serum creatinine \> 2.5 mg/dL \[221 µmol/L\] or a calculated creatinine clearance \< 25 ml/min is excluded)
3. Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, platelet count \< 50,000/mm3 or hemoglobin \< 10 g/dL, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
4. Moderate to severe hepatic impairment
5. Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors)
6. Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of CYP 3A4 or P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
7. Ongoing need for strong dual inducers of CYP 3A4 or P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
4. Received an investigational drug in the past 30 days
5. Participants considered by the investigator to be unsuitable for the study for any of the following reasons:
1. Not agreeable for treatment with either aspirin or apixaban or anticipated to have poor compliance on study drug treatment
2. Unwilling to attend study follow-up visits
3. Life expectancy less than the expected duration of the trial2 years due to concomitant disease
6. Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sterilization, hormonal contraceptives, intrauterine device, barrier methods or abstinence)
55 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Pfizer
INDUSTRY
Medtronic
INDUSTRY
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Population Health Research Institute
OTHER
Responsible Party
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Jeff Healey
Principal Investigator
Principal Investigators
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Jeff Healey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Stuart Connolly, M.D.
Role: STUDY_CHAIR
Population Health Research Institute
Marco Alings, M.D.
Role: PRINCIPAL_INVESTIGATOR
Working Group Cardiovascular Research Netherlands
Renato Lopes, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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Cardiovascular Associates of Mesa, PC
Mesa, Arizona, United States
St. Vincent Heart Clinic
Little Rock, Arkansas, United States
Cardiovascular Associates of Marin and San Francisco Medical
Larkspur, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Naples Interventional Cardiac Electrophysiology
Naples, Florida, United States
Langhorne Cardiology Consultants, Inc.
Pensacola, Florida, United States
One Health Cardiology, Owensboro Health, Inc.
Owensboro, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
University of Missouri Health System
Columbia, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Glacier View Cardiology
Kalispell, Montana, United States
The Cooper Health System
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
St. Peter's Health Partners Medical Association, PC
Albany, New York, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
Research Institute of LG Health / Penn Medicine
Lancaster, Pennsylvania, United States
Virginia Heart
Falls Church, Virginia, United States
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Vivalia CSL St. Joseph
Arlon, , Belgium
Clinique Saint Jean-Brussels
Brussels, , Belgium
Grand Hopital de Charleroi
Gilly, , Belgium
AZ Groeninge
Kortrijk, , Belgium
University Hospitals Leuven
Leuven, , Belgium
CHC Saint Joseph
Liège, , Belgium
CHR de la Citadelle
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
CHU Dinant-Godinne
Yvoir, , Belgium
University of Calgary Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Grey Nuns Hospital
Edmonton, Alberta, Canada
Heart Rhythm Research Office - St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnepeg, Manitoba, Canada
Capital District Health Authority
Halifax, Nova Scotia, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Mary's General Hospital
Kitchener, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Oakville Cardiologists
Oakville, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Institute Universitaire de Cardiologie and de Pneumonologie
Laval, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHUM - Hotel Dieu
Montreal, Quebec, Canada
Hopital Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUS - Sherbrooke
Sherbrooke, Quebec, Canada
Ciusss McQ
Trois-Rivières, Quebec, Canada
IKEM Institute for Clinical and Experimental Medicine
Prague, , Czechia
Hilleroed Hospital
Hilleroed, North Zealand, Denmark
Sygehus Sonderjylland
Aabenraa, , Denmark
Aalborg University Hospital, Dept of Cardiology
Aalborg, , Denmark
Aarhus Unniversity Hospital, Skejby
Aarhus, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Odense University Hospital
Odense, , Denmark
Hjertemedicinsk Forskning, RH Viborg, HEM
Viborg, , Denmark
Johann Wolfgang Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
Katholisches Klinikum Mainz
Mainz, Rhineland-Palatinate, Germany
Universitatsklinikum des Saarlandes
Homburg/Saar, Saarland, Germany
MVZ am Kuchwald GmbH
Chemnitz, Saxony, Germany
Zentrum fur klinische Prufungen in der Facharztzentrum Dresd
Dresden, Saxony, Germany
University Medicine Gottingen
Göttingen, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Universitaetsklinikum Tuebingen, Kardiologie
Tübingen, , Germany
Allami Szivkorhaz Balatonfured
Balatonfüred, Veszprém megye, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Ospedale Sant'Anna
San Fermo Della Batt, Como, Italy
Cardiologia-A.O. Desio e Vimercate - Presisio di Vimercat
Vimercate, Monza Brianza MB, Italy
Hospital Santa Maria Della Pieta
Nola, Napoli, Italy
AOU Ospedali Riuniti
Ancona, , Italy
Ospedale Maggiore, Cardiologia Dept.
Bologna, , Italy
S.Orsola-Malpighi
Bologna, , Italy
Bolzano Regional Hospital, Dept of Cardiology
Bolzano, , Italy
Azienda Ospedaliero-Univeritaria Di Modena-Policlinico
Modena, , Italy
Ospedale G.B. Grassi
Rome, , Italy
University and Hospital of Trieste
Trieste, , Italy
Gelre Ziekenhuis
Zutphen, Gelderland, Netherlands
Atrium Orbis Heerlen
Heerlen, Limburg, Netherlands
Amphia Hospital Breda
Breda, North Brabant, Netherlands
Ziekenhuis Tjongerschans
Heerenveen, Provincie Friesland, Netherlands
Ikazia Ziekenhuis
Rotterdam, South Holland, Netherlands
BovenIJ Ziekenhuis
Amsterdam, , Netherlands
Hospital Rijnstate
Arnhem, , Netherlands
Deventer Hospital, Cardiology Research
Deventer, , Netherlands
Hospital Gelderse Vallei
Ede, , Netherlands
Treant Hospital Department Cardiology
Emmen, , Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, , Netherlands
Treant Hospital - Bethseda, Hoogeveen
Hoogeveen, , Netherlands
Bravis Ziekenhuis, locatie Roosendaal
Roosendaal, , Netherlands
(ETZ) Elisabeth Tweesteden Hospital
Tilburg, , Netherlands
Máxima Medisch Centrum
Veldhoven, , Netherlands
Barum Hospital, Vestre Viken
Drammen, Buskerud, Norway
Oslo University Hospital - Ulleval
Oslo, , Norway
Hospital Clinico Santiago de Compostela
Santiago de Composte, A Coruna, Spain
Rafael Mendez Universitary Hospital
Lorca, Murcia, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Juan Ramon Jimenez
Huelva, , Spain
Hospital Clinico San Carlos, Unidad De Arritmias
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, , Spain
Agencia Sanitaria Costa del Sol- Hospital Costa del Sol
Marbella, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Kantonsspital St Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
CHUV
Lausanne, Canton of Vaud, Switzerland
Hopital Fribourgeois, site de Fribourg
Fribourg, , Switzerland
University Hospital of Geneva
Geneva, , Switzerland
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, United Kingdom
Hampshire Hospitals (NHS Foundation Trust)
Basingstoke, Hampshire, United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom
Royal Alexandra Hospital
Paisley, Renfrewshire, United Kingdom
Shrewsbury & Telford Hospital NHS
Shropshire, West Midlands, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Shoamanesh A, Field TS, Coutts SB, Sharma M, Gladstone D, Hart RG, Boriani G, Wright DJ, Sticherling C, Birnie DH, Gold MR, Erath JW, Kutyifa V, Mian R, Benz AP, Granger CB, McIntyre WF, Connolly SJ, Nielsen JC, Alings M, Rivard L, Lopes RD, Healey JS; ARTESiA study investigators. Apixaban versus aspirin for stroke prevention in people with subclinical atrial fibrillation and a history of stroke or transient ischaemic attack: subgroup analysis of the ARTESiA randomised controlled trial. Lancet Neurol. 2025 Feb;24(2):140-151. doi: 10.1016/S1474-4422(24)00475-7.
McIntyre WF, Benz AP, Healey JS, Connolly SJ, Yang M, Lee SF, Field TS, Alings M, Benezet-Mazuecos J, Boriani G, Nielsen JC, Gold MR, Pergolini F, Glotzer TV, Granger CB, Lopes RD. Risk of Stroke or Systemic Embolism According to Baseline Frequency and Duration of Subclinical Atrial Fibrillation: Insights From the ARTESiA Trial. Circulation. 2024 Nov 26;150(22):1747-1755. doi: 10.1161/CIRCULATIONAHA.124.069903. Epub 2024 Sep 4.
Lopes RD, Granger CB, Wojdyla DM, McIntyre WF, Alings M, Mani T, Ramasundarahettige C, Rivard L, Atar D, Birnie DH, Boriani G, Amit G, Leong-Sit P, Rinne C, Duray GZ, Gold MR, Hohnloser SH, Kutyifa V, Benezet-Mazuecos J, Cosedis Nielsen J, Sticherling C, Benz AP, Linde C, Kautzner J, Mabo P, Mairesse GH, Connolly SJ, Healey JS. Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA. J Am Coll Cardiol. 2024 Jul 23;84(4):354-364. doi: 10.1016/j.jacc.2024.05.002. Epub 2024 May 19.
Healey JS, Lopes RD, Granger CB, Alings M, Rivard L, McIntyre WF, Atar D, Birnie DH, Boriani G, Camm AJ, Conen D, Erath JW, Gold MR, Hohnloser SH, Ip J, Kautzner J, Kutyifa V, Linde C, Mabo P, Mairesse G, Benezet Mazuecos J, Cosedis Nielsen J, Philippon F, Proietti M, Sticherling C, Wong JA, Wright DJ, Zarraga IG, Coutts SB, Kaplan A, Pombo M, Ayala-Paredes F, Xu L, Simek K, Nevills S, Mian R, Connolly SJ; ARTESIA Investigators. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med. 2024 Jan 11;390(2):107-117. doi: 10.1056/NEJMoa2310234. Epub 2023 Nov 12.
Other Identifiers
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2014-001397-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARTESiA
Identifier Type: -
Identifier Source: org_study_id
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