Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
NCT ID: NCT02943785
Last Updated: 2022-03-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1426 participants
INTERVENTIONAL
2017-03-21
2021-02-28
Brief Summary
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Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters.
Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Edoxaban-based Regimen
Edoxaban-based regimen 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing must follow the locally approved label.
Edoxaban-based Regimen
15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
VKA-based Regimen
VKA-based regimen oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator will monitor the patient and adjust the VKA dose to maintain the dose within target.
VKA-based Regimen
Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
Interventions
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Edoxaban-based Regimen
15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
VKA-based Regimen
Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
3. the analysis of results
18 Years
ALL
No
Sponsors
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Chiltern International Inc.
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Sarver Heart Center
Tucson, Arizona, United States
Arkansas Site Management Services
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Cedar-Sinai Heart Institute
Los Angeles, California, United States
UCLA Cardiovascular Center
Los Angeles, California, United States
University of California - San Francisco
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Medical Facility Associates
Washington D.C., District of Columbia, United States
Cardiology Associate Research
Daytona Beach, Florida, United States
International Research Partners, LLC.
Doral, Florida, United States
Memorial Healthcare Systems
Hollywood, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Watson Clinic Center for Research
Lakeland, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
St. Vincent Heart Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Maine Medical Center
Scarborough, Maine, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Baystate Health
Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
MidMichigan Medical Center Midland
Midland, Michigan, United States
Michigan Heart, St. Joseph Mercy Health System
Ypsilanti, Michigan, United States
Essentia Health
Duluth, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
HealthEast Medical Research Institute
Saint Paul, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Clinical Investigators LLC
St Louis, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
NY Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, United States
St. Francis Hospital
East Hills, New York, United States
St. Joseph's Physicians
East Syracuse, New York, United States
Rochester General Hospital
Geneva, New York, United States
Northshore Community Hospital
Manhasset, New York, United States
Mt. Sinai Hospital
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, United States
East Carolina Heart Institute
Greenville, North Carolina, United States
Promedica Toledo Hospital
Toledo, Ohio, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
Southern Oregon Cardiology
Medford, Oregon, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Doylestown Health Cardiothoracic Surgery
Doylestown, Pennsylvania, United States
Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Pinnacle Health
Wormleysburg, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
SCRI - Centennial Medical Center
Nashville, Tennessee, United States
Seton Heart Institute
Austin, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
University of Texas Health Science Center Houston
Houston, Texas, United States
Legacy Heart Center
Plano, Texas, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Providence Sacred Heart Medical Research Center
Spokane, Washington, United States
CAMC Memorial Hospital
Charleston, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medizinische Universitaet Graz
Graz, , Austria
Clinic Wels-Grieskirchen GmbH
Grieskirchen, , Austria
Universitaetsklinik fuer Innere Medizin III
Innsbruck, , Austria
Klinikum Klagenfurt am Worthersee
Klagenfurt, , Austria
Wilhelminenspital
Vienna, , Austria
Universitätsklinik für Innere Medizin II
Vienna, , Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
Vienna, , Austria
ASZ Aalst - Aalst campus
Aalst, , Belgium
ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen
Antwerp, , Belgium
Hospital Erasme
Brussels, , Belgium
UZA - Universtiair Ziekenhuis Antwerpen
Edegem, , Belgium
ZOL Genk, Campus Sint-Jan
Genk, , Belgium
Jessa Ziekenhuis- Campus Virga Jessa
Hasselt, , Belgium
CHU de Liege
Liège, , Belgium
AZ Delta Roeselare
Roeselare, , Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Newmarket Cardiac Surgery Research Incorporated
Newmarket, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hamilton General Hospital
Hamilton, , Canada
Universitè Laval
Québec, , Canada
Horizon Health Network
Saint John, , Canada
CHU d'Angers
Angers, , France
Clinique Saint Augustin
Bordeaux, , France
Hopital Henri Mondor
Créteil, , France
Institut Coeur Poumon - CHRU de Lille
Lille, , France
CHU Arnaud de Villeneuve
Montpellier, , France
Clinique du Millenaire Service de Cardiologie Interventionelle
Montpellier, , France
Institut Mutualiste Montsouris
Paris, , France
Hopital Bichat
Paris, , France
CHU de Bordeaux Hopital du Haut Leveque
Pessac, , France
CHU de Rouen
Rouen, , France
Clinique Saint-Hilaire
Rouen, , France
Nouvel Hopital Civil
Strasbourg, , France
Clinique Pasteur / GCVI
Toulouse, , France
Kerckhoff-Klinik
Bad Nauheim, , Germany
Herz und Gefaess Klinik
Bad Neustadt an der Saale, , Germany
Segeberger Kliniken
Bad Segeberg, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Berlin, , Germany
Gesundheit Nord gGmbH
Bremen, , Germany
Klinikum der Stadt Ludwigshafen
Dortmund, , Germany
St. Johannes - Hospital
Dortmund, , Germany
Heart Center Dresden, University Clinic Technical University Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie
Essen, , Germany
Klinikum Fulda gAG
Fulda, , Germany
Universitatsklinikum Halle (Saale)
Halle, , Germany
Asklepios St. Georg Abteilung fuer Kardiologie
Hamburg, , Germany
Heidelberg University Hospital
Heidelberg, , Germany
Universitaetsklinik Schleswig-Holstein Campus Kiel
Kiel, , Germany
MediClin Herzzentrum Lahr/Baden
Lahr, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Universitatsmedizin Mainz, Zentrum fur Kardiologie
Mainz, , Germany
Deutsches Herzzentrum Munchen
München, , Germany
Universitatsklinikum Essen, Klinik fur Kardiologie
München, , Germany
Klinikum rechts der Isar der Technischen Universitat Munchen
München, , Germany
Klinikum Oldenburg AöR
Oldenburg, , Germany
Uniklinikum Regensburg, Med II
Regensburg, , Germany
Krankenhaus der Barmherzigen
Trier, , Germany
Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III
Tübingen, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Helios Herzzentrum Wuppertal
Wuppertal, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Ospedali Riuniti Torrette Di Ancona
Ancona, , Italy
Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
ASST Spedali Civili di Brescia-UO Cardiologia
Brescia, , Italy
AOU Policlinico Vittorio Emanuele
Catania, , Italy
Magna Graecia University
Catanzaro, , Italy
Ospedale S. Croce e Carle
Cuneo, , Italy
Citta di Lecce Hospital
Lecce, , Italy
Azienda Socio Sanitaria Territoriale di Lecco
Lecco, , Italy
ASST Ovest Milanese - Presidio Ospedallero di Legnana
Legnano, , Italy
Fondazione Toscana Gabriele Monasterio
Massa, , Italy
Ospedale San Raffaele
Milan, , Italy
Centro Cardiologico Monzino IRCCS
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Clinica Mediterranea
Napoli, , Italy
A.A Dei Colli Monaldi UOC Cardiologia Interventistica
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Centro Cuore Morgagni
Pedara, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
IRCCS-ASMN Reggio Emilia
Reggio Emilia, , Italy
AO San Camillo Forlanini
Rome, , Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, , Italy
AOU Careggi, Interventistica Cardiologica Strutturale
Rome, , Italy
Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
AOU S.Giovanni Di Dio e Ruggi D'Aragona
Salerno, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
UOC Emodinamica III
Siena, , Italy
Azienda Ospedaliera Integrata di Verona
Verona, , Italy
Nagoya Heart Center
Toyohashi, Aichi-ken, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Tsukuba Medical Center Hospital
Amakubo, Ibaraki, Japan
Teikyo University Hospital
Tokyo, Itabashi, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Osaka City University Hospital
Abeno Ward, Osaka, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Keio University Hospital
Shinjuku, Tokyo, Japan
Toyohashi Heart Center
Aichi, , Japan
New Tokyo Hospital
Chiba, , Japan
Shonan Kamakura General Hospital
Kanagawa, , Japan
Toyama University Hospital
Toyama, , Japan
Academic Medical Center
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
University Clinical Centre in Gdańsk
Gdansk, , Poland
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Seoul St. Mary's Hospital
Seoul, Seocho-gu, South Korea
Yonsei University Severance Hospital
Seoul, Seodaemun-gu, South Korea
Korean University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Complexo Hospitalario Universitario de A Coruna
A Coruña, , Spain
Complexo hospitalario universitario de Santiago de Compostela
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinico y Provincial de Barcelona
Barcelona, , Spain
Complejo Asistencial de Granada
Granada, , Spain
Hospital La Luz QuironSalud
Madrid, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Valdecilla Hospital
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico de Valencia
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, , Spain
Universitatsspital Basel
Basel, , Switzerland
Bern University Hospital
Bern, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
BSUH, Cardiac Research Unit
Brighton, England, United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, England, United Kingdom
Royal Edinburgh Infirmary
Edinburgh, England, United Kingdom
Guys St Thomas Hospital
London, England, United Kingdom
Trent Cardiac Centre
Nottingham, England, United Kingdom
Oxford University Hospitals, John Radcliffe Hospital
Oxford, England, United Kingdom
Northern General Hospital
Sheffield, England, United Kingdom
University Hospital of Wales, Heath Park
Cardiff, Wales, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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References
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Dangas GD, Unverdorben M, Nicolas J, Hengstenberg C, Chen C, Mollmann H, Jin J, Shawl F, Yamamoto M, Saito S, Hambrecht R, Duggal A, Van Mieghem NM. Comparing Major Gastrointestinal Bleeding in Patients Receiving Edoxaban Versus Warfarin After Transcatheter Aortic Valve Replacement: Results From the Randomized ENVISAGE-TAVI AF Trial. J Am Heart Assoc. 2025 May 20;14(10):e033321. doi: 10.1161/JAHA.123.033321. Epub 2025 May 15.
Van Mieghem NM, Unverdorben M, Hengstenberg C, Mollmann H, Mehran R, Lopez-Otero D, Nombela-Franco L, Moreno R, Nordbeck P, Thiele H, Lang I, Zamorano JL, Shawl F, Yamamoto M, Watanabe Y, Hayashida K, Hambrecht R, Meincke F, Vranckx P, Jin J, Boersma E, Rodes-Cabau J, Ohlmann P, Capranzano P, Kim HS, Pilgrim T, Anderson R, Baber U, Duggal A, Laeis P, Lanz H, Chen C, Valgimigli M, Veltkamp R, Saito S, Dangas GD; ENVISAGE-TAVI AF Investigators. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med. 2021 Dec 2;385(23):2150-2160. doi: 10.1056/NEJMoa2111016. Epub 2021 Aug 28.
Giacoppo D. Anticoagulation After Transcatheter Aortic Valve Replacement: Evolving Answers and Still Unaddressed Questions. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1714-1716. doi: 10.1016/j.jcin.2021.06.004. Epub 2021 Jul 14. No abstract available.
Van Mieghem NM, Unverdorben M, Valgimigli M, Mehran R, Boersma E, Baber U, Hengstenberg C, Shi M, Chen C, Saito S, Veltkamp R, Vranckx P, Dangas GD. Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018 Nov;205:63-69. doi: 10.1016/j.ahj.2018.07.006. Epub 2018 Aug 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-003930-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DU176B-C-U4001
Identifier Type: -
Identifier Source: org_study_id
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