Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

a study on Heart Conditions Atrial Fibrillation

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 accepting new patients
    San Francisco, California, 94143, United States
  • Southern Oregon Cardiology accepting new patients
    Medford, Oregon, 97504, United States
  • Providence Heart and Vascular Institute accepting new patients
    Portland, Oregon, 97225, United States
  • University of Arizona Sarver Heart Center accepting new patients
    Tucson, Arizona, 85724, United States
  • Providence Sacred Heart Medical Research Center accepting new patients
    Spokane, Washington, 99208, United States
  • New Mexico Heart Institute accepting new patients
    Albuquerque, New Mexico, 87102, United States
  • Black Hills Cardiovascular Research accepting new patients
    Rapid City, South Dakota, 57701, United States
  • University of Alberta Hospital accepting new patients
    Edmonton, Alberta, T6G 2R7, Canada
  • Oklahoma Heart Hospital Research Foundation accepting new patients
    Oklahoma City, Oklahoma, 73120, United States
  • Legacy Heart Center accepting new patients
    Plano, Texas, 75024, United States
  • Seton Heart Institute accepting new patients
    Austin, Texas, 78745, United States
  • St. Vincent Heart Center accepting new patients
    Indianapolis, Indiana, 77030, United States
  • Houston Methodist Research Institute accepting new patients
    Houston, Texas, 77030, United States
  • University of Texas Health Science Center Houston accepting new patients
    Houston, Texas, 77030, United States
  • Mayo Clinic Rochester accepting new 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 accepting new patients
    Iowa City, Iowa, 52242, United States
  • Essentia Health accepting new patients
    Duluth, Minnesota, 55805, United States
  • Clinical Investigators LLC accepting new patients
    Saint Louis, Missouri, 63119, United States
  • Jackson Heart Clinic accepting new patients
    Jackson, Mississippi, 39216, United States
  • Carle Foundation Hospital accepting new patients
    Urbana, Illinois, 61801, United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham, Alabama, 35233, United States
  • Sparrow Clinical Research Institute accepting new patients
    Lansing, Michigan, 48912, United States
  • MidMichigan Medical Center Midland accepting new patients
    Midland, Michigan, 48670, United States
  • Promedica Toledo Hospital accepting new patients
    Toledo, Ohio, 43615, United States
  • Michigan Heart, St. Joseph Mercy Health System accepting new 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
  • Kingston Health Sciences Centre accepting new patients
    Kingston, Ontario, K7L 2V7, Canada
  • London Health Sciences Centre accepting new patients
    London, Ontario, N6A 5W9, Canada
  • Newmarket Cardiac Surgery Research Incorporated accepting new patients
    Newmarket, Ontario, L3Y 3S9, Canada
  • Sunnybrook Health Sciences Centre accepting new patients
    Toronto, Ontario, M4N 3M5, 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 accepting new patients
    Charleston, West Virginia, 25404, United States
  • Watson Clinic Center for Research accepting new patients
    Lakeland, Florida, 33805, United States
  • Rochester General Hospital accepting new patients
    Geneva, New York, 14456, United States
  • Cardiology Associate Research accepting new patients
    Daytona Beach, Florida, 32117, United States
  • Pinnacle Health accepting new patients
    Wormleysburg, Pennsylvania, 17043, United States
  • Medical Facility Associates accepting new patients
    Washington, District of Columbia, 20037, United States
  • Medstar Washington Hospital Center accepting new patients
    Washington, District of Columbia, 20010, United States
  • Washington Adventist Hospital accepting new patients
    Takoma Park, Maryland, 20912, United States
  • Penn State Health, Milton S. Hershey Medical Center accepting new patients
    Hershey, Pennsylvania, 17033, United States
  • WellSpan York Hospital accepting new patients
    York, Pennsylvania, 17403, United States
  • St. Joseph's Physicians accepting new patients
    East Syracuse, New York, 13057, United States
  • East Carolina Heart Institute accepting new patients
    Greenville, North Carolina, 27834, United States
  • St. Luke's University Health Network accepting new patients
    Bethlehem, Pennsylvania, 18015, United States
  • Doylestown Health Cardiothoracic Surgery accepting new patients
    Doylestown, Pennsylvania, 18901, United States
  • International Research Partners, LLC. accepting new patients
    Doral, Florida, 33166, United States
  • Memorial Healthcare Systems accepting new patients
    Hollywood, Florida, 33021, United States
  • The Valley Hospital accepting new patients
    Paramus, New Jersey, 07652, United States
  • Hackensack University Medical Center accepting new patients
    Hackensack, New Jersey, 07601, United States
  • NY Presbyterian - Brooklyn Methodist Hospital accepting new patients
    Brooklyn, New York, 11215, United States
  • Mt. Sinai Hospital accepting new patients
    New York, New York, 10029, United States
  • Universitè Laval accepting new patients
    Québec, G1V 4G5, Canada
  • University of Massachusetts Memorial Medical Center accepting new patients
    Worcester, Massachusetts, 01655, United States
  • Horizon Health Network accepting new patients
    Saint John, E2L4L2, Canada
  • BSUH, Cardiac Research Unit accepting new patients
    Brighton, England, BN2 5BE, United Kingdom
  • Royal Edinburgh Infirmary accepting new patients
    Edinburgh, England, EH16 4SA, United Kingdom
  • Guys St Thomas Hospital accepting new patients
    London, England, SE1 7EH, United Kingdom
  • Oxford University Hospitals, John Radcliffe Hospital accepting new patients
    Oxford, England, OX3 9DU, United Kingdom
  • Northern General Hospital accepting new patients
    Sheffield, England, S5 7AU, United Kingdom
  • University Hospital of Wales, Heath Park accepting new patients
    Cardiff, Wales, CF14 4XW, United Kingdom
  • University Hospitals of Leicester NHS Trust accepting new patients
    Leicester, LE3 9QP, United Kingdom
  • Derriford Hospital accepting new patients
    Plymouth, PL6 8DH, United Kingdom
  • Academic Medical Center accepting new patients
    Amsterdam, 1105 AZ, Netherlands
  • Medisch Centrum Leeuwarden accepting new patients
    Leeuwarden, 8934 AD, Netherlands
  • Erasmus Medical Center accepting new patients
    Rotterdam, 3015 CN, Netherlands
  • ASZ Aalst - Aalst campus accepting new patients
    Aalst, 9300, Belgium
  • ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen accepting new patients
    Antwerpen, 2060, Belgium
  • UZA - Universtiair Ziekenhuis Antwerpen accepting new patients
    Edegem, 2650, Belgium
  • ZOL Genk, Campus Sint-Jan accepting new patients
    Genk, 3600, Belgium
  • Jessa Ziekenhuis- Campus Virga Jessa accepting new patients
    Hasselt, 3500, Belgium
  • Kerckhoff-Klinik accepting new patients
    Bad Nauheim, 61231, Germany
  • Herz und Gefaess Klinik accepting new patients
    Bad Neustadt An Der Saale, 97616, Germany
  • Segeberger Kliniken accepting new patients
    Bad Segeberg, 23795, Germany
  • Gesundheit Nord gGmbH accepting new patients
    Bremen, 28277, Germany
  • St. Johannes - Hospital accepting new patients
    Dortmund, 44137, Germany
  • Universitätsklinikum Düsseldorf accepting new patients
    Düsseldorf, 40225, Germany
  • Asklepios St. Georg Abteilung fuer Kardiologie accepting new patients
    Hamburg, 20099, Germany
  • MediClin Herzzentrum Lahr/Baden accepting new patients
    Lahr, 77933, Germany
  • Herzzentrum Leipzig accepting new patients
    Leipzig, 4289, Germany
  • Deutsches Herzzentrum Munchen accepting new patients
    München, 80636, Germany
  • Klinikum Oldenburg AöR accepting new patients
    Oldenburg, 26133, Germany
  • Uniklinikum Regensburg, Med II accepting new patients
    Regensburg, 93042, Germany
  • Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III accepting new patients
    Tuebingen, 72076, Germany
  • Universitatsklinikum Wurzburg accepting new patients
    Würzburg, 97080, Germany
  • CHU d'Angers accepting new patients
    Angers, France
  • Hopital Henri Mondor accepting new patients
    Créteil, 94000, France
  • Institut Coeur Poumon - CHRU de Lille accepting new patients
    Lille, 59000, France
  • CHU Arnaud de Villeneuve accepting new patients
    Montpellier, 34295, France
  • Clinique du Millenaire Service de Cardiologie Interventionelle accepting new patients
    Montpellier, 34960, France
  • Institut Mutualiste Montsouris accepting new patients
    Paris, 75014, France
  • Hopital Bichat accepting new patients
    Paris, 75877, France
  • CHU de Bordeaux Hopital du Haut Leveque accepting new patients
    Pessac, 33604, France
  • Clinique Saint-Hilaire accepting new patients
    Rouen, 76000, France
  • Clinique Pasteur / GCVI accepting new patients
    Toulouse, 31300, France
  • Hospital Universitario Central de Asturias accepting new patients
    Oviedo, Asturias, 33011, Spain
  • Complexo hospitalario universitario de Santiago de Compostela accepting new patients
    A Coruña, 15706, Spain
  • Hospital General Universitario de Alicante accepting new patients
    Alicante, 03540, Spain
  • Complejo Asistencial de Granada accepting new patients
    Grenada, 18014, Spain
  • Hospital Universitario Ramón y Cajal accepting new patients
    Madrid, 28034, Spain
  • Hospital Clinico San Carlos accepting new patients
    Madrid, 28040, Spain
  • Hospital Universitario La Paz accepting new patients
    Madrid, 28046, Spain
  • Hospital Virgen de la Arrixaca accepting new patients
    Murcia, 31020, Spain
  • Hospital Universitario Virgen de la Victoria accepting new patients
    Málaga, 29010, Spain
  • Hospital Universitario Alvaro Cunqueiro accepting new patients
    Vigo, 36312, Spain
  • Bern University Hospital accepting new patients
    Bern, 3010, Switzerland
  • Hopitaux Universitaires de Geneve accepting new patients
    Geneve, 1205, Switzerland
  • Medizinische Universitaet Graz accepting new patients
    Graz, 8036, Austria
  • Universitaetsklinik fuer Innere Medizin III accepting new patients
    Innsbruck, 6020, Austria
  • Universitätsklinik für Innere Medizin II accepting new patients
    Vienna, 1090, Austria
  • Wilhelminenspital accepting new patients
    Wien, 1060, Austria
  • AOU Policlinico Vittorio Emanuele accepting new patients
    Catania, 95123, Italy
  • Fondazione Toscana Gabriele Monasterio accepting new patients
    Massa, 54100, Italy
  • IRCCS-ASMN Reggio Emilia accepting new patients
    Reggio Emilia, 42123, Italy
  • UOC Emodinamica III accepting new patients
    Siena, 53100, Italy

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT02943785
Phase
Phase 3
Study Type
Interventional
Last Updated
April 27, 2018
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