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Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation (ELIMINATE-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Edoxaban
VKA-Based Regimen
VKA-Based Regimen
VKA-Based Regimen
VKA-Based Regimen
Sponsored by
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary).
  • Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
  • Signed informed consent form (ICF).

Exclusion Criteria:

  • AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).
  • Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization.
  • Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
  • Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
  • Subject has signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Hemostasis (ISTH), or conditions associated with high risk of bleeding
  • Subjects with any contraindication for anticoagulant agents.

Sites / Locations

  • ZNA Middelheim
  • Erasme Hospital
  • UZ Brussel
  • Universitair Ziekenhuis Antwerpen
  • University of Calgary
  • Hamilton Health Sciences/McMaster University
  • Montreal Heart Institute
  • Centre Hospitalier Universitaire de Sherbrooke
  • FN Brno
  • St. Anne's University Hospital Brno, International Clinical Research Center
  • IKEM
  • University Hospital Motol - Cardiology
  • FN Kralovske Vinohrady
  • VFN v Praze II. Interní klinika - Kardiologie a angiologie
  • Masarykova nemocnice - Kardiologie Krajská zdravotní, a.s.
  • Universitäts Herzzentrum Freiburg-Bad Krozingen Klinik für Kardiologie und Angiologie II
  • Charité Universitätsmedizin Berlin - CVK Medizinische Klinik m.S. Kardiologie
  • Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin
  • Klinikum Coburg GmbH II.Med.Klinik
  • Klinik für Innere Medizin I
  • University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology
  • Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie
  • University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology
  • Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie
  • Univ. of Muenster.Cardiovascular Medicine
  • Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie
  • Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie
  • Universitätsklinikum Ulm
  • Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
  • Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály
  • Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika
  • Pecs University Clinical Center
  • Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ
  • Zala Megyei Szent Rafael Kórház Kardiológia Osztály
  • Ospedale San Donato
  • Pineta Grande Hospital
  • Universita' degli Studi Catanzaro
  • Arcispedale Sant'Anna
  • Azienda USL Toscana
  • Ospedale della Misericordia
  • Ospedale dell'Angelo
  • ASST Vimercate
  • Ospedale Santo Cuore
  • Istituto di Cura cittè di Pavia
  • Azienda Ospedaliera di Piacenza "Ospedale Guglielmo d Saliceto"
  • Policlinico Casilino
  • Largo Agostino Gemelli
  • Ospedale Ecclesiastico "Miulli"
  • Samsung Medical Center
  • Seoul National University Hospital
  • Yonsei University Severance Hospital
  • Korea University Anam Hospital
  • Asan Medical Center
  • University Hospital - Szpital Uniwersytecki
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii
  • Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ
  • Oddział Kliniczny Kardiologii SUM Katedra Kardiologii
  • Klinika Intensywnej Terapii Kardiologicznej
  • Hospital General Universitario
  • Hospital del Mar
  • Hospital Clinic Cardiologia
  • Fundacion Jimenez Diaz
  • Hospital Universitario San Juan de Alicante
  • Chang Gung Memorial Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital (VGH-TC)
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital
  • Blackpool Teaching Hospitals NHS
  • Royal Bournemouth Hospital
  • Papworth Hospital NHS Trust
  • Leeds General Infirmary
  • King's College Hospital
  • Nottingham City 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 for 21 days pre- and 90 days post-ablation period.

VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced the Composite of All-cause Death, Stroke (VARC-2), and Major Bleeding (ISTH) in the Edoxaban Group Compared With Vitamin K Antagonist (VKA) Group in Participants Undergoing Catheter Ablation (Adjudicated Data)
Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
Number of Participants Who Experienced Major Bleeding (International Society on Thrombosis and Hemostasis [ISTH]) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)
Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.

Secondary Outcome Measures

Number of Participants Who Experienced the Composite of All-cause Death, Stroke (Alternative), and Major Bleeding (ISTH) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)
An alternative definition characterized stroke (ischemic, hemorrhagic, or undetermined) as an abrupt onset, over minutes to hours, of a focal neurological deficit in the distribution of a single brain artery that was not due to an identifiable nonvascular cause (ie, brain tumor or trauma), and that either lasted at least 24 hours or resulted in death within 24 hours of onset. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
Number of Participants Who Experienced the Composite of Stroke (VARC-2), Systemic Embolic Events (SEE), and Cardiovascular (CV) Mortality in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)
Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. SEE was defined as an arterial embolism resulting in clinical ischemia, excluding the central nervous system, coronary, and pulmonary arterial circulation. CV mortality was defined as cardiac or vascular death according to Academic Research Consortium.

Full Information

First Posted
October 21, 2016
Last Updated
August 26, 2019
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT02942576
Brief Title
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
Acronym
ELIMINATE-AF
Official Title
A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation (ELIMINATE-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

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

5. Study Description

Brief Summary
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Edoxaban-based regimen
Arm Type
Experimental
Arm Description
Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.
Arm Title
VKA-based regimen
Arm Type
Active Comparator
Arm Description
VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Lixiana
Intervention Description
Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects.
Intervention Type
Drug
Intervention Name(s)
VKA-Based Regimen
Other Intervention Name(s)
Warfarin
Intervention Description
Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea.
Intervention Type
Drug
Intervention Name(s)
VKA-Based Regimen
Other Intervention Name(s)
Phenprogamma, Phenprocoumon
Intervention Description
Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
Intervention Type
Drug
Intervention Name(s)
VKA-Based Regimen
Other Intervention Name(s)
Previscan, Fluindione
Intervention Description
Dosed at INR levels. Standard of Care treatment in France.
Intervention Type
Drug
Intervention Name(s)
VKA-Based Regimen
Other Intervention Name(s)
Sintrom, Acenocoumarol
Intervention Description
Dosed at INR levels. Standard of Care treatment in Spain.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced the Composite of All-cause Death, Stroke (VARC-2), and Major Bleeding (ISTH) in the Edoxaban Group Compared With Vitamin K Antagonist (VKA) Group in Participants Undergoing Catheter Ablation (Adjudicated Data)
Description
Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
Time Frame
Day 1 to Day 90
Title
Number of Participants Who Experienced Major Bleeding (International Society on Thrombosis and Hemostasis [ISTH]) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)
Description
Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
Time Frame
Day 1 to Day 90
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced the Composite of All-cause Death, Stroke (Alternative), and Major Bleeding (ISTH) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)
Description
An alternative definition characterized stroke (ischemic, hemorrhagic, or undetermined) as an abrupt onset, over minutes to hours, of a focal neurological deficit in the distribution of a single brain artery that was not due to an identifiable nonvascular cause (ie, brain tumor or trauma), and that either lasted at least 24 hours or resulted in death within 24 hours of onset. Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
Time Frame
Day 1 to Day 90
Title
Number of Participants Who Experienced the Composite of Stroke (VARC-2), Systemic Embolic Events (SEE), and Cardiovascular (CV) Mortality in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)
Description
Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death. SEE was defined as an arterial embolism resulting in clinical ischemia, excluding the central nervous system, coronary, and pulmonary arterial circulation. CV mortality was defined as cardiac or vascular death according to Academic Research Consortium.
Time Frame
Day 1 to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary). Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included). Signed informed consent form (ICF). Exclusion Criteria: AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.). Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization. Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass. Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization. Subject has signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Hemostasis (ISTH), or conditions associated with high risk of bleeding Subjects with any contraindication for anticoagulant agents.
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
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University of Calgary
City
Calgary
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Hamilton Health Sciences/McMaster University
City
Hamilton
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
FN Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
St. Anne's University Hospital Brno, International Clinical Research Center
City
Brno
ZIP/Postal Code
69691
Country
Czechia
Facility Name
IKEM
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Facility Name
University Hospital Motol - Cardiology
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
FN Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
VFN v Praze II. Interní klinika - Kardiologie a angiologie
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Masarykova nemocnice - Kardiologie Krajská zdravotní, a.s.
City
Ústí nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Universitäts Herzzentrum Freiburg-Bad Krozingen Klinik für Kardiologie und Angiologie II
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin - CVK Medizinische Klinik m.S. Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Klinikum Coburg GmbH II.Med.Klinik
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Klinik für Innere Medizin I
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Univ. of Muenster.Cardiovascular Medicine
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pecs University Clinical Center
City
Pécs
ZIP/Postal Code
H 7624
Country
Hungary
Facility Name
Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Kórház Kardiológia Osztály
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Ospedale San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Pineta Grande Hospital
City
Castel Volturno
ZIP/Postal Code
81030
Country
Italy
Facility Name
Universita' degli Studi Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Arcispedale Sant'Anna
City
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
Azienda USL Toscana
City
Firenze
ZIP/Postal Code
50122
Country
Italy
Facility Name
Ospedale della Misericordia
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
ASST Vimercate
City
Monza
ZIP/Postal Code
80082
Country
Italy
Facility Name
Ospedale Santo Cuore
City
Negrar
ZIP/Postal Code
37024
Country
Italy
Facility Name
Istituto di Cura cittè di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera di Piacenza "Ospedale Guglielmo d Saliceto"
City
Piacenza
ZIP/Postal Code
29124
Country
Italy
Facility Name
Policlinico Casilino
City
Roma
ZIP/Postal Code
00169
Country
Italy
Facility Name
Largo Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale Ecclesiastico "Miulli"
City
Sant'Eramo
ZIP/Postal Code
70021
Country
Italy
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
State/Province
Seodaemun-Gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seoungbuk-gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
University Hospital - Szpital Uniwersytecki
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Oddział Kliniczny Kardiologii SUM Katedra Kardiologii
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Klinika Intensywnej Terapii Kardiologicznej
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Hospital General Universitario
City
Alicante
ZIP/Postal Code
03540
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic Cardiologia
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario San Juan de Alicante
City
San Juan de Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital (VGH-TC)
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Blackpool Teaching Hospitals NHS
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Papworth Hospital NHS Trust
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
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), US and/or Japan marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both 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 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/
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Learn more about this trial

Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

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