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

NCT02943785 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: DU176B-C-U40012016-003930-26
• Study Type: interventional
• Target: 1,426
• Locations: 14 countries
• Sites: 230

Brief Summary

When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation. 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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA

  The composite endpoint net adverse clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Haemostasis (ISTH\].

  Baseline through study completion, up to 36 months post-dose

• Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA

  ISTH Bleeding Criteria for Major Bleeding are defined as clinically overt bleeding that is associated with: a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or a transfusion of 2 or more units of whole blood or packed red blood cells, or symptomatic bleeding into a critical site or organ such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, or intramuscular with compartment syndrome, or a fatal outcome.

  Baseline through study completion, up to 36 months post-dose

Secondary Outcomes (10)

• Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA

  Baseline through study completion, up to 36 months post-dose

• Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA

  Baseline through study completion, up to 36 months post-dose

• Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA

  Baseline through study completion, up to 36 months post-dose

• Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)

  Baseline through study completion, up to 36 months post-dose

• Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)

  Baseline through study completion, up to 36 months post-dose

Study Arms (2)

Edoxaban-based Regimen

EXPERIMENTAL

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.

Drug: Edoxaban-based Regimen

VKA-based Regimen

ACTIVE COMPARATOR

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.

Drug: VKA-based Regimen

Interventions

Edoxaban-based Regimen DRUG

15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)

Also known as: Savaysa, Lixiana

Edoxaban-based Regimen

VKA-based Regimen DRUG

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).

VKA-based Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Chiltern International Inc.: collaborator

Study Sites (230)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724, United States

Location

Arkansas Site Management Services

Little Rock, Arkansas, 72211, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Cedar-Sinai Heart Institute

Los Angeles, California, 90048, United States

Location

UCLA Cardiovascular Center

Los Angeles, California, 90095, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105-4365, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Medical Facility Associates

Washington D.C., District of Columbia, 20037, United States

Location

Cardiology Associate Research

Daytona Beach, Florida, 32117, United States

Location

International Research Partners, LLC.

Doral, Florida, 33166, United States

Location

Memorial Healthcare Systems

Hollywood, Florida, 33021, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Watson Clinic Center for Research

Lakeland, Florida, 33805, United States

Location

Tallahassee Research Institute, Inc.

Tallahassee, Florida, 32308, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 77030, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Maine Medical Center

Scarborough, Maine, 04074-7133, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

MidMichigan Medical Center Midland

Midland, Michigan, 48670, United States

Location

Michigan Heart, St. Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

HealthEast Medical Research Institute

Saint Paul, Minnesota, 55104, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Clinical Investigators LLC

St Louis, Missouri, 63119, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

NY Presbyterian - Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

St. Francis Hospital

East Hills, New York, 11548, United States

Location

St. Joseph's Physicians

East Syracuse, New York, 13057, United States

Location

Rochester General Hospital

Geneva, New York, 14456, United States

Location

Northshore Community Hospital

Manhasset, New York, 11030, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8167, United States

Location

Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

Greensboro, North Carolina, 27401, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

Promedica Toledo Hospital

Toledo, Ohio, 43615, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

Southern Oregon Cardiology

Medford, Oregon, 97504, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Doylestown Health Cardiothoracic Surgery

Doylestown, Pennsylvania, 18901, United States

Location

Penn State Health, Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

Black Hills Cardiovascular Research

Rapid City, South Dakota, 57701, United States

Location

SCRI - Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Seton Heart Institute

Austin, Texas, 78745, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

Location

Legacy Heart Center

Plano, Texas, 75024, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Providence Sacred Heart Medical Research Center

Spokane, Washington, 99208, United States

Location

CAMC Memorial Hospital

Charleston, West Virginia, 25404, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Clinic Wels-Grieskirchen GmbH

Grieskirchen, 4710, Austria

Location

Universitaetsklinik fuer Innere Medizin III

Innsbruck, 6020, Austria

Location

Klinikum Klagenfurt am Worthersee

Klagenfurt, 9020, Austria

Location

Wilhelminenspital

Vienna, 1060, Austria

Location

Universitätsklinik für Innere Medizin II

Vienna, 1090, Austria

Location

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

Vienna, 1130, Austria

Location

ASZ Aalst - Aalst campus

Aalst, 9300, Belgium

Location

ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen

Antwerp, 2060, Belgium

Location

Hospital Erasme

Brussels, B-1070, Belgium

Location

UZA - Universtiair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

ZOL Genk, Campus Sint-Jan

Genk, 3600, Belgium

Location

Jessa Ziekenhuis- Campus Virga Jessa

Hasselt, 3500, Belgium

Location

CHU de Liege

Liège, B-4000, Belgium

Location

AZ Delta Roeselare

Roeselare, 8800, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2R7, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Newmarket Cardiac Surgery Research Incorporated

Newmarket, Ontario, L3Y 3S9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hamilton General Hospital

Hamilton, L8L 2X2, Canada

Location

Universitè Laval

Québec, G1V 4G5, Canada

Location

Horizon Health Network

Saint John, E2L4L2, Canada

Location

CHU d'Angers

Angers, France

Location

Clinique Saint Augustin

Bordeaux, 33074, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

Institut Coeur Poumon - CHRU de Lille

Lille, 59000, France

Location

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

Clinique du Millenaire Service de Cardiologie Interventionelle

Montpellier, 34960, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hopital Bichat

Paris, 75877, France

Location

CHU de Bordeaux Hopital du Haut Leveque

Pessac, 33604, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Clinique Saint-Hilaire

Rouen, 76000, France

Location

Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Clinique Pasteur / GCVI

Toulouse, 31300, France

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Herz und Gefaess Klinik

Bad Neustadt an der Saale, 97616, Germany

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Charite Universitatsmedizin Berlin

Berlin, 12200, Germany

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Berlin, 16321, Germany

Location

Gesundheit Nord gGmbH

Bremen, 28277, Germany

Location

Klinikum der Stadt Ludwigshafen

Dortmund, 44137, Germany

Location

St. Johannes - Hospital

Dortmund, 44137, Germany

Location

Heart Center Dresden, University Clinic Technical University Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie

Essen, 45138, Germany

Location

Klinikum Fulda gAG

Fulda, 36043, Germany

Location

Universitatsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Asklepios St. Georg Abteilung fuer Kardiologie

Hamburg, 20099, Germany

Location

Heidelberg University Hospital

Heidelberg, 69120, Germany

Location

Universitaetsklinik Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

MediClin Herzzentrum Lahr/Baden

Lahr, 77933, Germany

Location

Herzzentrum Leipzig

Leipzig, 4289, Germany

Location

Universitatsmedizin Mainz, Zentrum fur Kardiologie

Mainz, 55131, Germany

Location

Deutsches Herzzentrum Munchen

München, 80636, Germany

Location

Universitatsklinikum Essen, Klinik fur Kardiologie

München, 81379, Germany

Location

Klinikum rechts der Isar der Technischen Universitat Munchen

München, 81675, Germany

Location

Klinikum Oldenburg AöR

Oldenburg, 26133, Germany

Location

Uniklinikum Regensburg, Med II

Regensburg, 93042, Germany

Location

Krankenhaus der Barmherzigen

Trier, 54292, Germany

Location

Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III

Tübingen, 72076, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Helios Herzzentrum Wuppertal

Wuppertal, 42117, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Ospedali Riuniti Torrette Di Ancona

Ancona, 60030, Italy

Location

Policlinico Sant'Orsola-Malpighi

Bologna, 40138, Italy

Location

ASST Spedali Civili di Brescia-UO Cardiologia

Brescia, 25123, Italy

Location

AOU Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Magna Graecia University

Catanzaro, 88100, Italy

Location

Ospedale S. Croce e Carle

Cuneo, 12100, Italy

Location

Citta di Lecce Hospital

Lecce, 73100, Italy

Location

Azienda Socio Sanitaria Territoriale di Lecco

Lecco, 23900, Italy

Location

ASST Ovest Milanese - Presidio Ospedallero di Legnana

Legnano, 20025, Italy

Location

Fondazione Toscana Gabriele Monasterio

Massa, 54100, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Centro Cardiologico Monzino IRCCS

Milan, 20138, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Clinica Mediterranea

Napoli, 80122, Italy

Location

A.A Dei Colli Monaldi UOC Cardiologia Interventistica

Napoli, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35121, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Centro Cuore Morgagni

Pedara, 95030, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56124, Italy

Location

IRCCS-ASMN Reggio Emilia

Reggio Emilia, 42123, Italy

Location

AO San Camillo Forlanini

Rome, 00152, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, 00161, Italy

Location

AOU Careggi, Interventistica Cardiologica Strutturale

Rome, 00187, Italy

Location

Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica

Rome, 00189, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

AOU S.Giovanni Di Dio e Ruggi D'Aragona

Salerno, 84133, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Location

UOC Emodinamica III

Siena, 53100, Italy

Location

Azienda Ospedaliera Integrata di Verona

Verona, 37126, Italy

Location

Nagoya Heart Center

Toyohashi, Aichi-ken, 441-8530, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Gifu, 503-0864, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

Location

Tsukuba Medical Center Hospital

Amakubo, Ibaraki, 305-8558, Japan

Location

Teikyo University Hospital

Tokyo, Itabashi, 173-0003, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, 216-0015, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 230-8765, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan

Location

Osaka City University Hospital

Abeno Ward, Osaka, 545-8586, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan

Location

Keio University Hospital

Shinjuku, Tokyo, 160-0016, Japan

Location

Toyohashi Heart Center

Aichi, 441-8530, Japan

Location

New Tokyo Hospital

Chiba, 270-2232, Japan

Location

Shonan Kamakura General Hospital

Kanagawa, 247-0072, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 CN, Netherlands

Location

HagaZiekenhuis

The Hague, 2504 LN, Netherlands

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

University Clinical Centre in Gdańsk

Gdansk, 80-952, Poland

Location

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, 61-848, Poland

Location

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

Location

Yonsei University Severance Hospital

Seoul, Seodaemun-gu, South Korea

Location

Korean University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Complexo Hospitalario Universitario de A Coruna

A Coruña, 15006, Spain

Location

Complexo hospitalario universitario de Santiago de Compostela

A Coruña, 15706, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03540, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinico y Provincial de Barcelona

Barcelona, 08036, Spain

Location

Complejo Asistencial de Granada

Granada, 18014, Spain

Location

Hospital La Luz QuironSalud

Madrid, 28003, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, 31020, Spain

Location

Valdecilla Hospital

Santander, 39008, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico de Valencia

Valencia, 46010, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Universitario Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Universitatsspital Basel

Basel, 4031, Switzerland

Location

Bern University Hospital

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1205, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

BSUH, Cardiac Research Unit

Brighton, England, BN2 5BE, United Kingdom

Location

Papworth Hospital NHS Foundation Trust

Cambridge, England, CB23 3RE, United Kingdom

Location

Royal Edinburgh Infirmary

Edinburgh, England, EH16 4SA, United Kingdom

Location

Guys St Thomas Hospital

London, England, SE1 7EH, United Kingdom

Location

Trent Cardiac Centre

Nottingham, England, NG5 1PB, United Kingdom

Location

Oxford University Hospitals, John Radcliffe Hospital

Oxford, England, OX3 9DU, United Kingdom

Location

Northern General Hospital

Sheffield, England, S5 7AU, United Kingdom

Location

University Hospital of Wales, Heath Park

Cardiff, Wales, CF14 4XW, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE3 9QP, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (5)

• Van Mieghem NM, Chen C, Hengstenberg C, Van Zyl J, Kimura T, Lang I, Mehran R, Nicolas J, Unverdorben M, Zamorano JL, Dangas GD. Edoxaban Dose Adjustment and Age-Associated Outcomes in Patients With Atrial Fibrillation Post-Transcatheter Aortic Valve Replacement. JACC Adv. 2025 Nov 19;4(12):102329. doi: 10.1016/j.jacadv.2025.102329. Online ahead of print.

  PMID: 41263742 DERIVED

• 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.

  PMID: 40371611 DERIVED

• 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.

  PMID: 34449183 DERIVED

• 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.

  PMID: 34274293 DERIVED

• 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.

  PMID: 30172099 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

+ 1 908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: March 21, 2017
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

CH (4); US (66); GB (10); NL (5); BE (8); FR (13); DE (29); AU (7); JP (18); PL (3); KR (5); CA (10); IT (30); ES (22)