Last updated on April 2018

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation


Brief description of study

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

Detailed Study Description

Device-detected sub-clinical atrial fibrillation (SCAF) is a new disorder that has been recognized since the availability of implantable devices capable of long term continuous heart rhythm monitoring. It is characterized by one or more runs of rapid atrial arrhythmia detected by the device without symptoms and without any clinical atrial fibrillation (AF) detected by the usual methods, (i.e. electrocardiogram, Holter monitor, etc.). In the ASSERT trial, SCAF was detected by a pacemaker or implantable cardioverter defibrillator (ICD) in nearly 40% of patients during 2 and a half years of follow up. The presence of SCAF increased stroke risk by 2.5-fold (1). The risk of stroke or systemic embolism among patients with SCAF and a CHADS2 score 4 was 2.75% per year. Oral anticoagulation is effective and safe for stroke prevention in patients with clinical atrial fibrillation, but it is unknown if the same risk benefit ratio exists for anticoagulation therapy in patients with SCAF (2;3). SCAF differs from clinical AF in being of shorter duration, being asymptomatic, and often have a more regular rhythm in the right atrium where it is typically detected. Data ASSERT suggest that the increase in stroke risk with SCAF may be less than the increase with clinical AF. Therefore opinion leaders have written that the role of oral anticoagulation for the treatment of SCAF is uncertain and that randomized trials of anticoagulation are needed (4;5). Recent surveys of pacemaker clinic practice indicate that only 25% of patients with SCAF are treated with oral anticoagulation (6;7). Thus there is clinical equipoise for a trial of oral anticoagulation compared to aspirin in higher risk patients with SCAF.

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.

Clinical Study Identifier: NCT01938248

Contact Investigators or Research Sites near you

Start Over

Kim Simek

Cardiovascular Associates of Mesa, PC
Mesa, AZ United States
  Connect »

Kim Simek

St. Vincent Heart Clinic
Little Rock, AR United States
  Connect »

Kim Simek

Cardiovascular Associates of Marin and San Francisco Medical
Larkspur, CA United States
  Connect »

Kim Simek

Aurora Denver Cardiology Associates
Aurora, CO United States
  Connect »

Kim Simek

Naples Interventional Cardiac Electrophysiology
Naples, FL United States
  Connect »

Kim Simek

One Health Cardiology, Owensboro Health, Inc.
Owensboro, KY United States
  Connect »

Kim Simek

University of Missouri Health System
Columbia, MO United States
  Connect »

Kim Simek

Glacier View Cardiology
Kalispell, MT United States
  Connect »

Kim Simek

Hackensack University Medical Center
Hackensack, NJ United States
  Connect »

Kim Simek

St. Peter's Health Partners Medical Association, PC
Albany, NY United States
  Connect »

Kim Simek

Carolinas Healthcare System
Charlotte, NC United States
  Connect »

Kim Simek

WakeMed
Raleigh, NC United States
  Connect »

Kim Simek

Cleveland Clinic
Cleveland, OH United States
  Connect »

Kim Simek

Pennsylvania State University
Hershey, PA United States
  Connect »

Kim Simek

Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
  Connect »

Kim Simek

Vivalia CSL St. Joseph
Arlon, Belgium
  Connect »

Kim Simek

Clinique Saint Jean-Brussels
Brussels, Belgium
  Connect »

Kim Simek

Grand Hopital de Charleroi
Gilly, Belgium
  Connect »

Kim Simek

AZ Groeninge
Kortrijk, Belgium
  Connect »

Kim Simek

University Hospitals Leuven
Leuven, Belgium
  Connect »

Kim Simek

CHC Saint Joseph
Liege, Belgium
  Connect »

Kim Simek

AZ Delta
Roeselare, Belgium
  Connect »

Kim Simek

CHU Dinant-Godinne
Yvoir, Belgium
  Connect »

Kim Simek

University of Calgary Foothills Hospital
Calgary, AB Canada
  Connect »

Kim Simek

Royal Alexandra Hospital
Edmonton, AB Canada
  Connect »

Kim Simek

University of Alberta Hospital
Edmonton, AB Canada
  Connect »

Kim Simek

Heart Rhythm Research Office - St. Paul's Hospital
Vancouver, BC Canada
  Connect »

Kim Simek

Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, BC Canada
  Connect »

Kim Simek

St. Boniface Hospital
Winnepeg, MB Canada
  Connect »

Kim Simek

Capital District Health Authority
Halifax, NS Canada
  Connect »

Kim Simek

Hamilton General Hospital
Hamilton, ON Canada
  Connect »

Kim Simek

St. Mary's General Hospital
Kitchener, ON Canada
  Connect »

Kim Simek

London Health Sciences Centre
London, ON Canada
  Connect »

Kim Simek

Southlake Regional Health Centre
Newmarket, ON Canada
  Connect »

Kim Simek

Oakville Cardiologists
Oakville, ON Canada
  Connect »

Kim Simek

University of Ottawa Heart Institute
Ottawa, ON Canada
  Connect »

Kim Simek

Health Sciences North
Sudbury, ON Canada
  Connect »

Kim Simek

St. Michael's Hospital
Toronto, ON Canada
  Connect »

Kim Simek

Sunnybrook Hospital
Toronto, ON Canada
  Connect »

Kim Simek

Institute Universitaire de Cardiologie and de Pneumonologie
Laval, QC Canada
  Connect »

Kim Simek

McGill University Health Centre
Montreal, QC Canada
  Connect »

Kim Simek

CHUM - Hotel Dieu
Montreal, QC Canada
  Connect »

Kim Simek

Hopital Sacre-Coeur de Montreal
Montreal, QC Canada
  Connect »

Kim Simek

Montreal Heart Institute
Montreal, QC Canada
  Connect »

Kim Simek

CHUS - Sherbrooke
Sherbrooke, QC Canada
  Connect »

Kim Simek

Sygehus Sonderjylland
Aabenraa, Denmark
  Connect »

Kim Simek

Aalborg University Hospital, Dept of Cardiology
Aalborg, Denmark
  Connect »

Kim Simek

Aarhus Unniversity Hospital, Skejby
Aarhus, Denmark
  Connect »

Kim Simek

Gentofte Hospital
Hellerup, Denmark
  Connect »

Kim Simek

Hilleroed Hospital
Hilleroed, Denmark
  Connect »

Kim Simek

Odense University Hospital
Odense, Denmark
  Connect »

Kim Simek

Hjertemedicinsk Forskning, RH Viborg, HEM
Viborg, Denmark
  Connect »

Kim Simek

S.Orsola-Malpighi
Bologna, Italy
  Connect »

Kim Simek

Bolzano Regional Hospital, Dept of Cardiology
Bolzano, Italy
  Connect »

Kim Simek

Azienda Ospedaliero-Univeritaria Di Modena-Policlinico
Modena, Italy
  Connect »

Kim Simek

Ziekenhuis Tjongerschans
Heerenveen, Netherlands
  Connect »

Kim Simek

Gelre Ziekenhuis
Zutphen, Netherlands
  Connect »

Kim Simek

Atrium Orbis Heerlen
Heerlen, Netherlands
  Connect »

Kim Simek

Amphia Hospital Breda
Breda, Netherlands
  Connect »

Kim Simek

Ikazia Ziekenhuis
Rotterdam, Netherlands
  Connect »

Kim Simek

BovenIJ Ziekenhuis
Amsterdam, Netherlands
  Connect »

Kim Simek

Hospital Rijnstate
Arnhem, Netherlands
  Connect »

Kim Simek

Deventer Hospital, Cardiology Research
Deventer, Netherlands
  Connect »

Kim Simek

Hospital Gelderse Vallei
Ede, Netherlands
  Connect »

Kim Simek

Treant Hospital Department Cardiology
Emmen, Netherlands
  Connect »

Kim Simek

Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
  Connect »

Kim Simek

Treant Hospital - Bethseda, Hoogeveen
Hoogeveen, Netherlands
  Connect »

Kim Simek

Bravis Ziekenhuis, locatie Roosendaal
Roosendaal, Netherlands
  Connect »

Kim Simek

(ETZ) Elisabeth Tweesteden Hospital
Tilburg, Netherlands
  Connect »

Kim Simek

M xima Medisch Centrum
Veldhoven, Netherlands
  Connect »

Kim Simek

Oslo University Hospital - Ulleval
Oslo, Norway
  Connect »

Kim Simek

Complexo Hospitalario Universitario A Coruna
A Coruna, Spain
  Connect »

Kim Simek

Hospital General Universitario de Alicante
Alicante, Spain
  Connect »

Kim Simek

Hospital Juan Ramon Jimenez
Huelva, Spain
  Connect »

Kim Simek

Hospital Clinico San Carlos, Unidad De Arritmias
Madrid, Spain
  Connect »

Kim Simek

Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
  Connect »

Kim Simek

Hospital Puerta de Hierro Majadahonda
Majadahonda, Spain
  Connect »

Kim Simek

Agencia Sanitaria Costa del Sol- Hospital Costa del Sol
Marbella, Spain
  Connect »

Kim Simek

Clinica Universidad de Navarra
Pamplona, Spain
  Connect »

Kim Simek

Hospital Clinico Universitario de Valencia
Valencia, Spain
  Connect »

Kim Simek

Hospital Cl nico Universitario de Valladolid
Valladolid, Spain
  Connect »

Kim Simek

Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
  Connect »

Kim Simek

Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
  Connect »

Kim Simek

Freeman Hospital
Newcastle-upon-Tyne, United Kingdom
  Connect »

Kim Simek

Langhorne Cardiology Consultants, Inc.
Pensacola, FL United States
  Connect »

Kim Simek

Tufts Medical Center
Boston, MA United States
  Connect »

Kim Simek

Sparrow Clinical Research Institute
Lansing, MI United States
  Connect »

Kim Simek

Michigan Heart
Ypsilanti, MI United States
  Connect »

Kim Simek

St. Louis Heart and Vascular
Saint Louis, MO United States
  Connect »

Kim Simek

The Cooper Health System
Camden, NJ United States
  Connect »

Kim Simek

The Valley Hospital
Ridgewood, NJ United States
  Connect »

Kim Simek

Research Institute of LG Health / Penn Medicine
Lancaster, PA United States
  Connect »

Kim Simek

Virginia Heart
Falls Church, VA United States
  Connect »

Kim Simek

Grey Nuns Hospital
Edmonton, AB Canada
  Connect »

Kim Simek

IKEM Institute for Clinical and Experimental Medicine
Prague, Czechia
  Connect »

Kim Simek

Johann Wolfgang Goethe University Hospital Frankfurt
Frankfurt, Germany
  Connect »

Kim Simek

Katholisches Klinikum Mainz
Mainz, Germany
  Connect »

Kim Simek

Universitatsklinikum des Saarlandes
Homburg/Saar, Germany
  Connect »

Kim Simek

MVZ am Kuchwald GmbH
Chemnitz, Germany
  Connect »

Kim Simek

Zentrum fur klinische Prufungen in der Facharztzentrum Dresd
Dresden, Germany
  Connect »

Kim Simek

University Medicine Gottingen
Gottingen, Germany
  Connect »

Kim Simek

Asklepios Klinik Barmbek
Hamburg, Germany
  Connect »

Kim Simek

Universitaetsklinikum Tuebingen, Kardiologie
Tuebingen, Germany
  Connect »

Kim Simek

Allami Szivkorhaz Balatonfured
Balatonfured, Hungary
  Connect »

Kim Simek

Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
  Connect »

Kim Simek

Semmelweis University
Budapest, Hungary
  Connect »

Kim Simek

Ospedale Sant'Anna
San fermo della Batt, Italy
  Connect »

Kim Simek

Cardiologia-A.O. Desio e Vimercate - Presisio di Vimercat
Vimercate, Italy
  Connect »

Kim Simek

Hospital Santa Maria Della Pieta
Nola, Italy
  Connect »

Kim Simek

AOU Ospedali Riuniti
Ancona, Italy
  Connect »

Kim Simek

Ospedale Maggiore, Cardiologia Dept.
Bologna, Italy
  Connect »

Kim Simek

Ospedale G.B. Grassi
Rome, Italy
  Connect »

Kim Simek

University and Hospital of Trieste
Trieste, Italy
  Connect »

Kim Simek

Barum Hospital, Vestre Viken
Drammen, Norway
  Connect »

Kim Simek

Hospital Clinico Santiago de Compostela
Santiago de Composte, Spain
  Connect »

Kim Simek

Rafael Mendez Universitary Hospital
Lorca, Spain
  Connect »

Kim Simek

Hospital Del Mar
Barcelona, Spain
  Connect »

Kim Simek

University Hospital Basel
Basel, Switzerland
  Connect »

Kim Simek

CHUV
Lausanne, Switzerland
  Connect »

Kim Simek

Hopital Fribourgeois, site de Fribourg
Fribourg, Switzerland
  Connect »

Kim Simek

University Hospital of Geneva
Geneva, Switzerland
  Connect »

Kim Simek

Kantonsspital St Gallen
St. Gallen, Switzerland
  Connect »

Kim Simek

Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom
  Connect »

Kim Simek

Hampshire Hospitals (NHS Foundation Trust)
Basingstoke, United Kingdom
  Connect »

Kim Simek

Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
  Connect »

Kim Simek

Royal Alexandra Hospital
Paisley, United Kingdom
  Connect »

Kim Simek

Shrewsbury & Telford Hospital NHS
Shropshire, United Kingdom
  Connect »

Kim Simek

Queen Elizabeth University Hospital
Glasgow, United Kingdom
  Connect »

Kim Simek

CHR de la Citadelle
Liège, Belgium
  Connect »

Kim Simek

Ciusss McQ
Trois-Rivières, QC Canada
  Connect »

Kim Simek

Ospedale Sant'Anna
San Fermo Della Batt, Italy
  Connect »

Kim Simek

Hospital Clinico Santiago de Compostela
Santiago De Composte, Spain
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.