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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation. Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter. Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter. The study will compare the two drugs for up to three years after heart valve replacement, looking at the drug's overall side effects (called adverse events) and major bleeding.

Official Title

Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation

Details

Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)

Objective:

  • To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).
  • To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).

Keywords

Atrial Fibrillation Transcatheter Aortic Valve Implantation -- TAVI Anticoagulation ENVISAGE-TAVI-AF Edoxaban

Eligibility

For people ages 18 years and up

Criteria : Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception
  • Is willing and able to comply with any restrictions related food, drink and medications
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Locations

  • University of California - San Francisco not yet accepting patients
    San Francisco, California, 94143, United States
  • Providence Heart and Vascular Institute not yet accepting patients
    Portland, Oregon, 97225, United States
  • University of Arizona Sarver Heart Center not yet accepting patients
    Tucson, Arizona, 85724, United States
  • Oklahoma Heart Hospital Research Foundation accepting new patients
    Oklahoma City, Oklahoma, 73120, United States
  • St. Vincent Heart Center not yet accepting patients
    Indianapolis, Indiana, 77030, United States
  • Houston Methodist Research Institute not yet accepting patients
    Houston, Texas, 77030, United States
  • University of Texas Health Science Center Houston accepting new patients
    Houston, Texas, 77030, United States
  • Mayo Clinic Rochester not yet accepting patients
    Rochester, Minnesota, 55905, United States
  • Arkansas Site Management Services accepting new patients
    Little Rock, Arkansas, 72211, United States
  • University of Iowa Hospitals and Clinics not yet accepting patients
    Iowa City, Iowa, 52242, United States
  • Essentia Health accepting new patients
    Duluth, Minnesota, 55805, United States
  • Jackson Heart Clinic accepting new patients
    Jackson, Mississippi, 39216, United States
  • Carle Foundation Hospital not yet accepting patients
    Urbana, Illinois, 61801, United States
  • University of Alabama at Birmingham not yet accepting patients
    Birmingham, Alabama, 35233, United States
  • Sparrow Clinical Research Institute not yet accepting patients
    Lansing, Michigan, 48912, United States
  • MidMichigan Medical Center Midland accepting new patients
    Midland, Michigan, 48670, United States
  • Michigan Heart, St. Joseph Mercy Health System not yet accepting patients
    Ypsilanti, Michigan, 48197, United States
  • Tallahassee Research Institute, Inc. accepting new patients
    Tallahassee, Florida, 32308, United States
  • Hamilton General Hospital accepting new patients
    Hamilton, L8L 2X2, Canada
  • Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health accepting new patients
    Greensboro, North Carolina, 27401, United States
  • CAMC Memorial Hospital not yet accepting patients
    Charleston, West Virginia, 25404, United States
  • Watson Clinic Center for Research not yet accepting patients
    Lakeland, Florida, 33805, United States
  • Cardiology Associate Research accepting new patients
    Daytona Beach, Florida, 32117, United States
  • Medical Facility Associates not yet accepting patients
    Washington, District of Columbia, 20037, United States
  • Washington Adventist Hospital accepting new patients
    Takoma Park, Maryland, 20912, United States
  • Penn State Health, Milton S. Hershey Medical Center not yet accepting patients
    Hershey, Pennsylvania, 17033, United States
  • WellSpan York Hospital accepting new patients
    York, Pennsylvania, 17403, United States
  • St. Joseph's Physicians not yet accepting patients
    East Syracuse, New York, 13057, United States
  • International Research Partners, LLC. not yet accepting patients
    Doral, Florida, 33166, United States
  • The Valley Hospital not yet accepting patients
    Paramus, New Jersey, 07652, United States
  • Hackensack University Medical Center not yet accepting patients
    Hackensack, New Jersey, 07601, United States
  • NY Presbyterian - Brooklyn Methodist Hospital not yet accepting patients
    Brooklyn, New York, 11215, United States
  • Mt. Sinai Hospital accepting new patients
    New York, New York, 10029, United States
  • Universitè Laval not yet accepting patients
    Québec, G1V 4G5, Canada
  • Horizon Health Network not yet accepting patients
    Saint John, E2L4L2, Canada
  • BSUH, Cardiac Research Unit accepting new patients
    Brighton, England, BN2 5BE, United Kingdom
  • Royal Edinburgh Infirmary not yet accepting patients
    Edinburgh, England, EH16 4SA, United Kingdom
  • Guys St Thomas Hospital not yet accepting patients
    London, England, SE1 7EH, United Kingdom
  • Oxford University Hospitals, John Radcliffe Hospital not yet accepting patients
    Oxford, England, OX3 9DU, United Kingdom
  • Northern General Hospital not yet accepting patients
    Sheffield, England, S5 7AU, United Kingdom
  • University Hospital of Wales, Heath Park accepting new patients
    Cardiff, Wales, CF14 4XW, United Kingdom
  • Academic Medical Center not yet accepting patients
    Amsterdam, 1105 AZ, Netherlands
  • Erasmus Medical Center accepting new patients
    Rotterdam, 3015 CN, Netherlands
  • ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen not yet accepting patients
    Antwerpen, 2060, Belgium
  • ZOL Genk, Campus Sint-Jan accepting new patients
    Genk, 3600, Belgium
  • Jessa Ziekenhuis- Campus Virga Jessa not yet accepting patients
    Hasselt, 3500, Belgium
  • Clinique Pasteur / GCVI not yet accepting patients
    Toulouse, 31300, France
  • Kerckhoff-Klinik not yet accepting patients
    Bad Nauheim, 61231, Germany
  • Segeberger Kliniken accepting new patients
    Bad Segeberg, 23795, Germany
  • Gesundheit Nord gGmbH not yet accepting patients
    Bremen, 28277, Germany
  • St. Johannes - Hospital accepting new patients
    Dortmund, 44137, Germany
  • Universitätsklinikum Düsseldorf not yet accepting patients
    Düsseldorf, 40225, Germany
  • Asklepios St. Georg Abteilung fuer Kardiologie accepting new patients
    Hamburg, 20099, Germany
  • MediClin Herzzentrum Lahr/Baden not yet accepting patients
    Lahr, 77933, Germany
  • Herzzentrum Leipzig not yet accepting patients
    Leipzig, 4289, Germany
  • Klinikum Oldenburg AöR not yet accepting patients
    Oldenburg, 26133, Germany
  • Uniklinikum Regensburg, Med II not yet accepting patients
    Regensburg, 93042, Germany
  • Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III not yet accepting patients
    Tuebingen, 72076, Germany
  • Hospital General Universitario de Alicante not yet accepting patients
    Alicante, 03540, Spain
  • Hospital Universitario Ramón y Cajal not yet accepting patients
    Madrid, 28034, Spain
  • Hospital Universitario Virgen de la Victoria not yet accepting patients
    Málaga, 29010, Spain
  • Hospital Universitario Alvaro Cunqueiro not yet accepting patients
    Vigo, 36312, Spain
  • Medizinische Universitaet Graz accepting new patients
    Graz, 8036, Austria
  • Universitaetsklinik fuer Innere Medizin III not yet accepting patients
    Innsbruck, 6020, Austria
  • Universitätsklinik für Innere Medizin II not yet accepting patients
    Vienna, 1090, Austria

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT02943785
Phase
Phase 3
Study Type
Interventional
Last Updated
November 21, 2017
I’m interested in this study!