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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Edoxaban-based Regimen
VKA-based Regimen
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Transcatheter Aortic Valve Implantation -- TAVI, Anticoagulation, Atrial Fibrillation, ENVISAGE-TAVI-AF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Arizona Sarver Heart Center
  • Arkansas Site Management Services
  • Loma Linda University Medical Center
  • Cedar-Sinai Heart Institute
  • UCLA Cardiovascular Center
  • University of California - San Francisco
  • Santa Barbara Cottage Hospital
  • Medstar Washington Hospital Center
  • Medical Facility Associates
  • Cardiology Associate Research
  • International Research Partners, LLC.
  • Memorial Healthcare Systems
  • UF Health Jacksonville
  • Watson Clinic Center for Research
  • Tallahassee Research Institute, Inc.
  • Rush University Medical Center
  • Carle Foundation Hospital
  • St. Vincent Heart Center
  • University of Iowa Hospitals and Clinics
  • Maine Medical Center
  • Washington Adventist Hospital
  • Baystate Health
  • University of Massachusetts Memorial Medical Center
  • Sparrow Clinical Research Institute
  • MidMichigan Medical Center Midland
  • Michigan Heart, St. Joseph Mercy Health System
  • Essentia Health
  • Mayo Clinic Rochester
  • HealthEast Medical Research Institute
  • Jackson Heart Clinic
  • Clinical Investigators LLC
  • Renown Regional Medical Center
  • Hackensack University Medical Center
  • The Valley Hospital
  • New Mexico Heart Institute
  • NY Presbyterian - Brooklyn Methodist Hospital
  • St. Francis Hospital
  • St. Joseph's Physicians
  • Rochester General Hospital
  • Northshore Community Hospital
  • Mt. Sinai Hospital
  • Stony Brook University Medical Center
  • Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
  • East Carolina Heart Institute
  • Promedica Toledo Hospital
  • Oklahoma Heart Hospital Research Foundation
  • Southern Oregon Cardiology
  • Providence Heart and Vascular Institute
  • St. Luke's University Health Network
  • Doylestown Health Cardiothoracic Surgery
  • Penn State Health, Milton S. Hershey Medical Center
  • Geisinger Wyoming Valley Medical Center
  • Pinnacle Health
  • WellSpan York Hospital
  • Black Hills Cardiovascular Research
  • SCRI - Centennial Medical Center
  • Seton Heart Institute
  • Houston Methodist Research Institute
  • University of Texas Health Science Center Houston
  • Legacy Heart Center
  • Inova Heart and Vascular Institute
  • Virginia Mason Medical Center
  • Providence Sacred Heart Medical Research Center
  • CAMC Memorial Hospital
  • Aurora St. Luke's Medical Center
  • Medizinische Universitaet Graz
  • Clinic Wels-Grieskirchen GmbH
  • Universitaetsklinik fuer Innere Medizin III
  • Klinikum Klagenfurt am Worthersee
  • Universitätsklinik für Innere Medizin II
  • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
  • Wilhelminenspital
  • ASZ Aalst - Aalst campus
  • ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen
  • Hospital Erasme
  • UZA - Universtiair Ziekenhuis Antwerpen
  • ZOL Genk, Campus Sint-Jan
  • Jessa Ziekenhuis- Campus Virga Jessa
  • CHU de Liege
  • AZ Delta Roeselare
  • University of Alberta Hospital
  • Kingston Health Sciences Centre
  • London Health Sciences Centre
  • Newmarket Cardiac Surgery Research Incorporated
  • Sunnybrook Health Sciences Centre
  • University Health Network
  • Montreal Heart Institute
  • Hamilton General Hospital
  • Universitè Laval
  • Horizon Health Network
  • CHU d'Angers
  • Clinique Saint Augustin
  • Hopital Henri Mondor
  • Institut Coeur Poumon - CHRU de Lille
  • CHU Arnaud de Villeneuve
  • Clinique du Millenaire Service de Cardiologie Interventionelle
  • Institut Mutualiste Montsouris
  • Hopital Bichat
  • CHU de Bordeaux Hopital du Haut Leveque
  • CHU de Rouen
  • Clinique Saint-Hilaire
  • Nouvel Hopital Civil
  • Clinique Pasteur / GCVI
  • Kerckhoff-Klinik
  • Herz und Gefaess Klinik
  • Segeberger Kliniken
  • Charite Universitatsmedizin Berlin
  • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Gesundheit Nord gGmbH
  • Klinikum der Stadt Ludwigshafen
  • St. Johannes - Hospital
  • Heart Center Dresden, University Clinic Technical University Dresden
  • Universitätsklinikum Düsseldorf
  • Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie
  • Klinikum Fulda gAG
  • Universitatsklinikum Halle (Saale)
  • Asklepios St. Georg Abteilung fuer Kardiologie
  • Heidelberg University Hospital
  • Universitaetsklinik Schleswig-Holstein Campus Kiel
  • MediClin Herzzentrum Lahr/Baden
  • Herzzentrum Leipzig
  • Universitatsmedizin Mainz, Zentrum fur Kardiologie
  • Klinikum rechts der Isar der Technischen Universitat Munchen
  • Deutsches Herzzentrum Munchen
  • Universitatsklinikum Essen, Klinik fur Kardiologie
  • Klinikum Oldenburg AöR
  • Uniklinikum Regensburg, Med II
  • Krankenhaus der Barmherzigen
  • Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III
  • Universitatsklinikum Ulm
  • Helios Herzzentrum Wuppertal
  • Universitatsklinikum Wurzburg
  • Ospedali Riuniti Torrette Di Ancona
  • Policlinico Sant'Orsola-Malpighi
  • ASST Spedali Civili di Brescia-UO Cardiologia
  • AOU Policlinico Vittorio Emanuele
  • Magna Graecia University
  • Ospedale S. Croce e Carle
  • Citta di Lecce Hospital
  • Azienda Socio Sanitaria Territoriale di Lecco
  • ASST Ovest Milanese - Presidio Ospedallero di Legnana
  • Fondazione Toscana Gabriele Monasterio
  • Ospedale San Raffaele
  • Centro Cardiologico Monzino IRCCS
  • ASST Grande Ospedale Metropolitano Niguarda
  • Clinica Mediterranea
  • A.A Dei Colli Monaldi UOC Cardiologia Interventistica
  • Azienda Ospedaliera di Padova
  • Fondazione IRCCS Policlinico San Matteo
  • IRCCS Policlinico San Matteo
  • Centro Cuore Morgagni
  • Azienda Ospedaliero-Universitaria Pisana
  • IRCCS-ASMN Reggio Emilia
  • AO San Camillo Forlanini
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I
  • AOU Careggi, Interventistica Cardiologica Strutturale
  • Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica
  • Istituto Clinico Humanitas
  • AOU S.Giovanni Di Dio e Ruggi D'Aragona
  • IRCCS Policlinico San Donato
  • UOC Emodinamica III
  • Azienda Ospedaliera Integrata di Verona
  • Nagoya Heart Center
  • Kokura Memorial Hospital
  • Ogaki Municipal Hospital
  • Sapporo Higashi Tokushukai Hospital
  • Tsukuba Medical Center Hospital
  • Teikyo University Hospital
  • Iwate Medical University Hospital
  • Tokai University Hospital
  • St. Marianna University School of Medicine Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Sendai Kousei Hospital
  • Osaka City University Hospital
  • Kishiwada Tokushukai Hospital
  • Keio University Hospital
  • Toyohashi Heart Center
  • New Tokyo Hospital
  • Shonan Kamakura General Hospital
  • Toyama University Hospital
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital
  • Yonsei University Severance Hospital
  • Korean University Anam Hospital
  • Asan Medical Center
  • Academic Medical Center
  • HagaZiekenhuis
  • University Medical Center Groningen
  • Medisch Centrum Leeuwarden
  • Erasmus Medical Center
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • University Clinical Centre in Gdańsk
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Central de Asturias
  • Hospital Universitari Germans Trias I Pujol
  • Hospital Universitario Donostia
  • Complexo hospitalario universitario de Santiago de Compostela
  • Hospital General Universitario de Alicante
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinico y Provincial de Barcelona
  • Complejo Asistencial de Granada
  • Complexo Hospitalario Universitario de A Coruna
  • Hospital La Luz QuironSalud
  • Hospital Universitario La Princesa
  • Hospital Universitario Ramón y Cajal
  • Hospital Clinico San Carlos
  • Hospital Universitario La Paz
  • Hospital Virgen de la Arrixaca
  • Hospital Universitario Virgen de la Victoria
  • Valdecilla Hospital
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico de Valencia
  • Hospital Clinico Universitario de Valladolid
  • Hospital Universitario Alvaro Cunqueiro
  • Universitatsspital Basel
  • Bern University Hospital
  • Hopitaux Universitaires de Geneve
  • Cardiocentro Ticino
  • BSUH, Cardiac Research Unit
  • Papworth Hospital NHS Foundation Trust
  • Royal Edinburgh Infirmary
  • Guys St Thomas Hospital
  • Trent Cardiac Centre
  • Oxford University Hospitals, John Radcliffe Hospital
  • Northern General Hospital
  • University Hospital of Wales, Heath Park
  • University Hospitals of Leicester NHS Trust
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban-based Regimen

VKA-based Regimen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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].
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.

Secondary Outcome Measures

Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA
The composite endpoint of net adverse event clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding based on Thrombolysis in Myocardial Infarction (TIMI) criteria. Bleeding by TIMI criteria was defined as the following: (1) Major, any intracranial hemorrhage or any clinically overt bleeding, (including bleeding evident in imaging studies) associated with a fall of hemoglobin (Hb) of ≥ 5g/dL or fatal bleeding and (2) Minor, any clinically overt bleeding associated with a fall in Hb ≥ 3g/dL but < 5 g/dL.
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
The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Bleeding Academic Research Consortium (BARC) Type 3 or 5 criteria. Major bleeding by BARC criteria was defined as Type 3: clinical, laboratory, and/or imaging evidence of bleeding with provider responses; Type 3a: any transfusion with overt bleeding; overt bleeding plus Hb drop of 3 to < 5 g/dL; Type 3b: overt bleeding plus Hb drop ≥ 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring intravenous vasoactive drugs; Type 3c: intracranial hemorrhage; subcategories confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 5: fatal bleeding; Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious; Type 5b: definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA
The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO). GUSTO criteria was defined as the following: severe or life threatening: intracerebral hemorrhage or resulting in substantial hemodynamic compromise requiring treatment and moderate: requiring blood transfusion but not resulting in hemodynamic compromise.
Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Major adverse cardiac events (MACE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, or repeat coronary revascularization of the target lesion.
Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Major adverse cardiac and cerebrovascular events (MACCE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, stroke (ischemic, hemorrhagic, or undetermined), or repeat coronary revascularization of the target lesion
Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)
A composite of clinical adverse events included cardiovascular death, MI ischemic stroke, SEE, valve thrombosis, and major bleeding as defined by ISTH criteria.
Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Stroke events are categorized as any stroke, fatal stroke, and non-fatal stroke.
Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Systemic thromboembolism [non-central nervous system] is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation).
Number of Participants Who Experienced Myocardial Infarctions (MI) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Peri-procedural MI was defined as new ischemic symptoms or signs and elevated cardiac biomarkers within 72 hours after index procedure, consisting of at least one sample post-procedure with a peak value exceeding 15x as the upper reference limit (URL) for troponin or 5x for CK-MB. Spontaneous MI is defined as any one of the following: Detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile URL, together with the evidence of myocardial ischemia with at least one of the following: Symptoms of ischemia; ECG changes indicative of new ischemia; New pathological Q-waves in at least two contiguous leads; Imaging evidence of a new loss of viable myocardium or new wall motion abnormality; Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischemia, and accompanied by new ST elevation or new left bundle branch block, and/or evidence of fresh thrombus; Pathological findings of an acute MI.
Number of Participants Who Experienced Valve Thrombosis in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Valve thrombosis was defined as any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.

Full Information

First Posted
October 21, 2016
Last Updated
March 22, 2022
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Chiltern International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02943785
Brief Title
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Chiltern International Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Transcatheter Aortic Valve Implantation -- TAVI, Anticoagulation, Atrial Fibrillation, ENVISAGE-TAVI-AF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban-based Regimen
Arm Type
Experimental
Arm Description
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.
Arm Title
VKA-based Regimen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Edoxaban-based Regimen
Other Intervention Name(s)
Savaysa, Lixiana
Intervention Description
15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
Intervention Type
Drug
Intervention Name(s)
VKA-based Regimen
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA
Description
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].
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA
Description
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.
Time Frame
Baseline through study completion, up to 36 months post-dose
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA
Description
The composite endpoint of net adverse event clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding based on Thrombolysis in Myocardial Infarction (TIMI) criteria. Bleeding by TIMI criteria was defined as the following: (1) Major, any intracranial hemorrhage or any clinically overt bleeding, (including bleeding evident in imaging studies) associated with a fall of hemoglobin (Hb) of ≥ 5g/dL or fatal bleeding and (2) Minor, any clinically overt bleeding associated with a fall in Hb ≥ 3g/dL but < 5 g/dL.
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
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
Description
The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Bleeding Academic Research Consortium (BARC) Type 3 or 5 criteria. Major bleeding by BARC criteria was defined as Type 3: clinical, laboratory, and/or imaging evidence of bleeding with provider responses; Type 3a: any transfusion with overt bleeding; overt bleeding plus Hb drop of 3 to < 5 g/dL; Type 3b: overt bleeding plus Hb drop ≥ 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring intravenous vasoactive drugs; Type 3c: intracranial hemorrhage; subcategories confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 5: fatal bleeding; Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious; Type 5b: definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA
Description
The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO). GUSTO criteria was defined as the following: severe or life threatening: intracerebral hemorrhage or resulting in substantial hemodynamic compromise requiring treatment and moderate: requiring blood transfusion but not resulting in hemodynamic compromise.
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
Major adverse cardiac events (MACE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, or repeat coronary revascularization of the target lesion.
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
Major adverse cardiac and cerebrovascular events (MACCE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, stroke (ischemic, hemorrhagic, or undetermined), or repeat coronary revascularization of the target lesion
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
A composite of clinical adverse events included cardiovascular death, MI ischemic stroke, SEE, valve thrombosis, and major bleeding as defined by ISTH criteria.
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
Stroke events are categorized as any stroke, fatal stroke, and non-fatal stroke.
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
Systemic thromboembolism [non-central nervous system] is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation).
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Myocardial Infarctions (MI) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
Peri-procedural MI was defined as new ischemic symptoms or signs and elevated cardiac biomarkers within 72 hours after index procedure, consisting of at least one sample post-procedure with a peak value exceeding 15x as the upper reference limit (URL) for troponin or 5x for CK-MB. Spontaneous MI is defined as any one of the following: Detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile URL, together with the evidence of myocardial ischemia with at least one of the following: Symptoms of ischemia; ECG changes indicative of new ischemia; New pathological Q-waves in at least two contiguous leads; Imaging evidence of a new loss of viable myocardium or new wall motion abnormality; Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischemia, and accompanied by new ST elevation or new left bundle branch block, and/or evidence of fresh thrombus; Pathological findings of an acute MI.
Time Frame
Baseline through study completion, up to 36 months post-dose
Title
Number of Participants Who Experienced Valve Thrombosis in Participants Taking Edoxaban vs VKA (Adjudicated Data)
Description
Valve thrombosis was defined as any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.
Time Frame
Baseline through study completion, up to 36 months post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona Sarver Heart Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Site Management Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Cedar-Sinai Heart Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Cardiovascular Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105-4365
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Medical Facility Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Cardiology Associate Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
International Research Partners, LLC.
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Memorial Healthcare Systems
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Watson Clinic Center for Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Tallahassee Research Institute, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
St. Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-7133
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Baystate Health
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
MidMichigan Medical Center Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Michigan Heart, St. Joseph Mercy Health System
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Essentia Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HealthEast Medical Research Institute
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55104
Country
United States
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Clinical Investigators LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
NY Presbyterian - Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
St. Francis Hospital
City
East Hills
State/Province
New York
ZIP/Postal Code
11548
Country
United States
Facility Name
St. Joseph's Physicians
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Rochester General Hospital
City
Geneva
State/Province
New York
ZIP/Postal Code
14456
Country
United States
Facility Name
Northshore Community Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8167
Country
United States
Facility Name
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
East Carolina Heart Institute
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Promedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Oklahoma Heart Hospital Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Southern Oregon Cardiology
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Providence Heart and Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Doylestown Health Cardiothoracic Surgery
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Penn State Health, Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Pinnacle Health
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
WellSpan York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Black Hills Cardiovascular Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
SCRI - Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Seton Heart Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Legacy Heart Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Providence Sacred Heart Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
CAMC Memorial Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25404
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Clinic Wels-Grieskirchen GmbH
City
Grieskirchen
ZIP/Postal Code
4710
Country
Austria
Facility Name
Universitaetsklinik fuer Innere Medizin III
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinikum Klagenfurt am Worthersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin II
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
ASZ Aalst - Aalst campus
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Hospital Erasme
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
UZA - Universtiair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
ZOL Genk, Campus Sint-Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis- Campus Virga Jessa
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHU de Liege
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
AZ Delta Roeselare
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Newmarket Cardiac Surgery Research Incorporated
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3S9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Universitè Laval
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Horizon Health Network
City
Saint John
ZIP/Postal Code
E2L4L2
Country
Canada
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Name
Clinique Saint Augustin
City
Bordeaux
ZIP/Postal Code
33074
Country
France
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Institut Coeur Poumon - CHRU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Clinique du Millenaire Service de Cardiologie Interventionelle
City
Montpellier
ZIP/Postal Code
34960
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
CHU de Bordeaux Hopital du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Clinique Saint-Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Clinique Pasteur / GCVI
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Herz und Gefaess Klinik
City
Bad Neustadt An Der Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Segeberger Kliniken
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Immanuel Klinikum Bernau Herzzentrum Brandenburg
City
Berlin
ZIP/Postal Code
16321
Country
Germany
Facility Name
Gesundheit Nord gGmbH
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
St. Johannes - Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Heart Center Dresden, University Clinic Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Klinikum Fulda gAG
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Asklepios St. Georg Abteilung fuer Kardiologie
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Heidelberg University Hospital
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinik Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
MediClin Herzzentrum Lahr/Baden
City
Lahr
ZIP/Postal Code
77933
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
4289
Country
Germany
Facility Name
Universitatsmedizin Mainz, Zentrum fur Kardiologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat Munchen
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Deutsches Herzzentrum Munchen
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Universitatsklinikum Essen, Klinik fur Kardiologie
City
München
ZIP/Postal Code
81379
Country
Germany
Facility Name
Klinikum Oldenburg AöR
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Uniklinikum Regensburg, Med II
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Krankenhaus der Barmherzigen
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Helios Herzzentrum Wuppertal
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
Universitatsklinikum Wurzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Ospedali Riuniti Torrette Di Ancona
City
Ancona
ZIP/Postal Code
60030
Country
Italy
Facility Name
Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Spedali Civili di Brescia-UO Cardiologia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
AOU Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Magna Graecia University
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale S. Croce e Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Citta di Lecce Hospital
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
ASST Ovest Milanese - Presidio Ospedallero di Legnana
City
Legnano
ZIP/Postal Code
20025
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio
City
Massa
ZIP/Postal Code
54100
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Centro Cardiologico Monzino IRCCS
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Clinica Mediterranea
City
Napoli
ZIP/Postal Code
80122
Country
Italy
Facility Name
A.A Dei Colli Monaldi UOC Cardiologia Interventistica
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35121
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Centro Cuore Morgagni
City
Pedara
ZIP/Postal Code
95030
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
IRCCS-ASMN Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
AO San Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
AOU Careggi, Interventistica Cardiologica Strutturale
City
Rome
ZIP/Postal Code
00187
Country
Italy
Facility Name
Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AOU S.Giovanni Di Dio e Ruggi D'Aragona
City
Salerno
ZIP/Postal Code
84133
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
Country
Italy
Facility Name
UOC Emodinamica III
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Nagoya Heart Center
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8530
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ōgaki
State/Province
Gifu
ZIP/Postal Code
503-0864
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
Tsukuba Medical Center Hospital
City
Amakubo
State/Province
Ibaraki
ZIP/Postal Code
305-8558
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
State/Province
Itabashi
ZIP/Postal Code
173-0003
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate Prefecture
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-0015
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
230-8765
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Osaka City University Hospital
City
Abeno Ward
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku City
State/Province
Tokyo
ZIP/Postal Code
160-0016
Country
Japan
Facility Name
Toyohashi Heart Center
City
Aichi
ZIP/Postal Code
441-8530
Country
Japan
Facility Name
New Tokyo Hospital
City
Chiba
ZIP/Postal Code
270-2232
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa
ZIP/Postal Code
247-0072
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
State/Province
Seodaemun-gu
Country
Korea, Republic of
Facility Name
Korean University Anam Hospital
City
Seoul
State/Province
Seongbuk-gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
Country
Korea, Republic of
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
HagaZiekenhuis
City
Den Haag
ZIP/Postal Code
2504 LN
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
University Clinical Centre in Gdańsk
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Donostia
City
Donostia
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complexo hospitalario universitario de Santiago de Compostela
City
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03540
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinico y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complejo Asistencial de Granada
City
Grenada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Complexo Hospitalario Universitario de A Coruna
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital La Luz QuironSalud
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
31020
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Valdecilla Hospital
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Universitario Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Universitatsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
BSUH, Cardiac Research Unit
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Royal Edinburgh Infirmary
City
Edinburgh
State/Province
England
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Guys St Thomas Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Trent Cardiac Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford University Hospitals, John Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
University Hospital of Wales, Heath Park
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
34449183
Citation
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.
Results Reference
derived
PubMed Identifier
34274293
Citation
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. Erratum In: JACC Cardiovasc Interv. 2021 Oct 25;14(20):2311-2313.
Results Reference
derived
PubMed Identifier
30172099
Citation
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.
Results Reference
derived

Learn more about this trial

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

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