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Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ENTRUST-AF-PCI)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Edoxaban
Clopidogrel
Prasugrel
Ticagrelor
Vitamin K antagonist
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 focused on measuring percutaneous intervention, vitamin K antagonist

Eligibility Criteria

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

Inclusion Criteria:

  • Oral anticoagulant (OAC) indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting.

Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage.

Successful PCI definition:

The success of a PCI procedure is defined by 2 interrelated components: angiographic findings, procedural / clinical outcomes as detailed below:

Angiographic Success A minimum stenosis diameter of < 20% (as visually assessed by angiography - residual blockage or stenosis reduced to less than 20% of the artery's diameter).

Sufficient enlargement of the lumen at the target site to improve coronary artery blood flow with final thrombolysis in myocardial infarction (TIMI) flow grade 3 (visually assessed by angiography), without occlusion of a significant side branch, flow-limiting dissection, distal embolization, or angiographic thrombus.

Procedural Success No major in-hospital clinical complications(e.g. ongoing International Society on Thrombosis and Haemostasis [ISTH] major or clinical relevant non-major procedural bleeding at the time of randomization, stroke, emergency coronary artery bypass graft [CABG]).

In summary, a clinically successful PCI requires both anatomic and procedural success along with relief of signs and/or symptoms of myocardial ischemia at the time of randomization.

Exclusion Criteria:

  • Bleeding risks or systemic conditions

  • Known bleeding diathesis, including but not limited to,

    1. Uncontrolled active bleeding, encompassing both ISTH major and clinically relevant non-major bleeding, preceding randomization.

      Lesion or condition, if considered to be a significant risk for major bleeding. This may include but is not limited to: unresolved gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding (e.g. malignancies with metastasis), recent unresolved brain or spinal injury, recent brain, spinal or ophthalmic surgery, any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms (of more than 3.5 cm) or major intraspinal or intracerebral vascular abnormalities.

    2. Medication-related
  • International normalized ratio (INR) > 2.5 (the participant can be reconsidered at a later time, but within 5 days of sheath removal).
  • Contraindication to edoxaban, VKA, acetylsalicylic acid (ASA) and/or P2Y12 antagonists;
  • Concomitant treatment with other antithrombotic agents, fibrinolytic therapy and chronic nonsteroidal anti-inflammatory drugs (NSAIDs).

Concomitant conditions and therapies

  • Critically ill or hemodynamically unstable subjects (at the time of randomization) including:

    1. cardiogenic shock or acute decompensated heart failure, with the requirement for vasopressor agents or inotropic support or mechanical support to support circulation
    2. respiratory failure requiring endotracheal intubation and mechanical ventilation.
  • Any prior mechanical valvular prosthesis;
  • Planned coronary or vascular intervention or major surgery within 12 months; Randomization must be deferred to the last stage in a multistep, multivessel PCI procedure;
  • Moderate or severe mitral stenosis;
  • Ischemic stroke within 2 weeks prior to randomization;
  • Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥ 120 mmHg;
  • End stage renal disease (ESRD) (CrCL < 15 mL/min or on dialysis);
  • Known abnormal liver function prior to randomization (including hepatic disease or biochemical evidence of significant liver derangement known prior to randomization).

Other exclusion criteria

  • Any of the following abnormal local laboratory results prior to randomization:

    1. Platelet count < 50 x10^9/L
    2. Hemoglobin < 8 mg/dL
  • Unable to provide written Informed Consent;
  • Female participants of childbearing potential without using highly effective contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study). Females taking oral contraceptives should have been on therapy for at least three months. Adequate contraceptives include: Combined (estrogen and progestogen containing) oral, intravaginal, transdermal, hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence;
  • Pregnant or breast-feeding participants;
  • Assessment that the participant is not likely to comply with the study procedures or have complete follow-up;
  • Participating in another clinical trial that potentially interferes with the current study;
  • Previous randomization in this study;
  • Active on prescription drug abuse and addiction; abuse of illicit substances (i.e. marijuana, cocaine, methamphetamine, heroin) and alcohol abuses during the last 12 months according to the judgement of the investigator;
  • Life expectancy < 12 months.

Sites / Locations

  • Medizinische Universitaetsklinik Graz
  • University Hospital Innsbruck
  • Krankenhaus Hietzing
  • Wilhelminenspital
  • ASZ Aalst
  • Imelda Ziekenhuis
  • AZ St Jan
  • Hopital Erasme
  • University Hospital Antwerp
  • Virga Jesse Jessa hospital
  • AZ Delta
  • University Hospital of Angers
  • Hopital Cote Basque
  • Chru Jean Minjoz
  • Metropole Savoie Hospital
  • Centre Hospitalier Sud Francilien
  • Hospital Henri Mondor
  • CHU de Nice
  • Hôpital Bichat - Claude Bernard
  • Hôpital Rangueil, Service Cancérologie
  • Clinique Vauban
  • University Hospital Aachen
  • Universitäts-Herzzentrum Freiburg • Bad Krozingen
  • Kerckhoff Klinik
  • Vivantes Klinikum im Friedrichshaim
  • Charité Benjamin Franklin
  • Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie
  • Staedtische Kliniken Bielefeld
  • GFO Kliniken Bonn - St.-Marien-Hospital
  • Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)
  • Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie
  • St. Johannes- Hospital
  • Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie
  • Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I
  • Universitäres Herzzentrum Hamburg GmbH (UHZ)
  • Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)
  • Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin
  • Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin
  • Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie
  • Klinikum Ludwigshafen
  • Städtisches Klinikum Lüneburg
  • Kliniken Maria Hilf GmbH
  • Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum
  • Universitätsklinikum Münster - Department für Kardiologie und Angiologie
  • St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II
  • Universitätsmedizin Rostock
  • Universitäts Klinikum Tübingen
  • Herzklinik Ulm
  • Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II
  • Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin
  • St. Josefs-Hospital - Medizinische Klinik I, Kardiologie
  • HELIOS Klinikum Wuppertal - Herzzentrum
  • Állami Szívkórház
  • Budai Irgalmasrendi Kht.
  • Gottsegen György Országos Kardiológiai Intézet
  • Bajcsy-Zsilinszky Kórház és Rendelőintézet
  • Magyar Honvédség Egészségügyi Központ
  • Debreceni Egyetem Klinikai Központ
  • Békés Megyei Központi Kórház
  • Petz Aladar Megyei Oktato Korhaz
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
  • Pécsi Tudományegyetem
  • Szegedi Tudományegyetem
  • Fejér Megyei Szent György Egyetemi Oktató Kórház
  • Ospedale San Donato- ASL 8 Arezzo
  • Policlinico di Bari
  • Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica
  • AOU Materdomini, Magna Graecia University
  • ASL2 Chieti - SS Maria Annunziata
  • A.S.O.S. Croce e Carle Cuneo
  • AOU Sant'Anna
  • Ospedale Careggi
  • Ospedali Riuniti di Foggia
  • Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco
  • Asst Fatebenefratelli-Sacco
  • AOU Policlinico di Modena
  • University Hospital Federico II
  • Padova University Hospital
  • Azienda Ospedaliero-Universitaria di Parma
  • Ospedale degli Infermi
  • Ospedale degli Infermi di Rivoli
  • Policlinico Agostino Gemelli
  • S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica
  • Bolognini Hospital Seriate
  • "Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni
  • U.O. Cardiologia Ospedale Borgo Trento
  • Pusan National University Hospital
  • Daegu Catholic University Hospital
  • Chonnam National University Hospital
  • Inje Univ. Ilsan Paik Hospital
  • The Catholic University of Korea St.Vincent's Hospital
  • Hallym University Sacred Heart Hospital
  • Inha University Hospital
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • Samsung Medical Centre
  • SEOUL St.Maria
  • Boramae Medical Center
  • Korea University Guro Hospital
  • Korea University Anam Hospital
  • Lithuanian University of Health Sciences hospital
  • Klaipeda Seamen's Hospital
  • Vilnius University Hospital "Santariskiu Clinic"
  • Republican Siauliai Hospital
  • St Antonius Hospital
  • Radboud university medical center
  • Maasstad Hospital
  • MC Haaglanden
  • II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca
  • MCSN AHoP
  • III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca
  • Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego
  • AHP IV DEP K-Kozle
  • Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca
  • Clin-Medica OMC sp. z o.o. s.k.
  • X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca
  • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej
  • Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca
  • Nzoz Salus
  • Hospital Garcia de Orta, EPE
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz
  • Centro Hospitalar e Universitário de Coimbra, EPE
  • Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões
  • Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta
  • Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
  • Emergency County Hospital Baia Mare
  • "Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases
  • University Hospital of Bucharest
  • Saint John Emergency Hospital
  • Oradea Emergency County Clinical Hospital
  • Institutul de Boli Cardiovasculare Timisoara
  • Emergency Institute of Cardiovascular Diseases and Transplantation
  • Clinical Center of Serbia
  • Clinical Hospital Center -Zvezdara
  • Institute of CV Diseases Clinical Center of Serbia
  • Clinical Center Kragujevac
  • Institute of Cardiovascular Diseases of Vojvodina
  • General University Hospital of Alicante
  • Hospital Universitari Germans Trias i Pujol
  • Complejo Hospitalario Universitario de Granada
  • Bellvitge University Hospital
  • Complejo Asistencial Universitario de León
  • Hospital Ramon y Cajal
  • Clinica Universitaria San Carlos
  • Hospital La Paz, Madrid
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario Virgen de La Victoria
  • Hospital Universitario de Salamanca
  • Hospital Universitari i Politècnic La Fe
  • Hospital Clínico Universitario de Valladolid
  • Hospital Álvaro Cunqueiro
  • HFR Freiburg - Kantonsspital Kardiologie
  • Cardiocentro Ticino
  • Hsinchu Mackay Memorial Hospital (HMMH)
  • Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)
  • E-DA Hospital
  • Far Eastern Memorial Hospital (FEMH)
  • China Medical University Hospital (CMUH)
  • Chi-Mei Medical Center (CMMC)
  • National Cheng Kung University Hospital
  • Cheng Hsin General Hospital
  • Taipei Veterans General Hospital
  • Chang-Gung Memorial Hospital
  • Cherkasy regional cardiological center
  • Chernihiv City Hospital #2
  • Chernivtsi Regional Clinical Cardiology Dispensary
  • CI "Dnipropetrovsk Joint Emergency Hospital"
  • Communal Institution Dnepropetrovsk Regional Diagnostic Center
  • Ivano-Frankivsk Central City Clinical Hospital
  • L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine
  • Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"
  • Kharkiv City Clinical Hospital #8
  • Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"
  • Khmelnytskyy regional hospital
  • Insititute of Heart of MoH Ukraine
  • Kyiv City Clinical Hospital#5
  • State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'
  • Kyiv City Clinical Hospital 4
  • Oleksandrivska Kiyv City Clinical Hospital
  • Communal Institution of Kyiv Regional Rada
  • Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center
  • Lutsk City Hospital
  • Nikolaev Regional Clinical Hospital
  • Odessa Regional Hospital, Cardiosurgery Center
  • Communal Institution Rivne Regional Clinical Hospital
  • Communal Institution of Sumy Regional Rada
  • Transcarpathian Regional Clinical Cardiology Clinic
  • Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"
  • Vinnytsya Regional Clinical Hospital n.a. Pyrogov
  • Zaporizhzhia Regional cardiology dispensary
  • Blackpool Victoria Hospital
  • University Hospital of Wales
  • Golden Jubilee Hospital
  • Royal Infirmary of Edinburgh
  • Altnagelvin Area Hospital
  • Southern Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban Regimen

Vitamin K Antagonist Regimen

Arm Description

Participants will be randomized to receive edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) used.

Participants will be randomized to receive VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.

Outcomes

Primary Outcome Measures

Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.

Secondary Outcome Measures

Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen
All major, clinically relevant non-major and minor bleeding are reported for the secondary outcome. Participants may have experiences more than 1 bleeding event, all occurrences are reported. Participants with International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: major or clinically relevant non-major bleeding (MCRB), major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Thrombolysis in Myocardial Infarction (TIMI) defined bleeding events included: Major bleeding (including fatal bleeding and non-fatal bleeding [fulfilling the TIMI major bleeding definition], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding (defined as composite of major, minor, and minimal bleeding)
Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Bleeding Academic Research Consortium (BARC) bleeding events included: Bleeding (defined by BARC type 3 or 5), bleeding (defined by BARC type 2, 3, or 5), and any bleeding (defined as the composite of BARC type 1, 2, 3, or 5), where increases in BARC type indicate worse outcome. Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consultation; Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation; Type 3: Overt bleeding plus hemoglobin drop of 3 to ≤5 g/dL (3a), ≥5 g/dl (3b), and intracranial hemorrhage (3c) Type 5: Fatal bleeding
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
The main efficacy endpoints were defined as the composite of cardiovascular death (ARC), stroke (protocol defined), systemic embolic event (SEE), myocardial infarction (MI), or definite stent thrombosis.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Treatment-emergent adverse events (TEAEs) in >1.0% of participants were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug.
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Study drug-related treatment-emergent adverse events (TEAEs) (experienced by 2 or more participants) were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug and were found to be related to treatment by the Investigator.

Full Information

First Posted
August 10, 2016
Last Updated
April 24, 2020
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT02866175
Brief Title
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
Acronym
ENTRUST-AF-PCI
Official Title
Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. 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
Keywords
percutaneous intervention, vitamin K antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban Regimen
Arm Type
Experimental
Arm Description
Participants will be randomized to receive edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5 mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) used.
Arm Title
Vitamin K Antagonist Regimen
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel [5mg or 10 mg once-daily] or ticagrelor [90 mg twice-daily] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Savaysa
Intervention Description
Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
Clopidogrel 75 mg once-daily
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Effient
Intervention Description
prasugrel 5mg or 10 mg once-daily
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
ticagrelor 90 mg twice-daily
Intervention Type
Drug
Intervention Name(s)
Vitamin K antagonist
Intervention Description
VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive
Primary Outcome Measure Information:
Title
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Description
Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.
Time Frame
Day 1 to 12 months postdose
Secondary Outcome Measure Information:
Title
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen
Description
All major, clinically relevant non-major and minor bleeding are reported for the secondary outcome. Participants may have experiences more than 1 bleeding event, all occurrences are reported. Participants with International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: major or clinically relevant non-major bleeding (MCRB), major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.
Time Frame
Day 1 to 12 months postdose
Title
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Description
Thrombolysis in Myocardial Infarction (TIMI) defined bleeding events included: Major bleeding (including fatal bleeding and non-fatal bleeding [fulfilling the TIMI major bleeding definition], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding (defined as composite of major, minor, and minimal bleeding)
Time Frame
Day 1 to 12 months postdose
Title
Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Description
Bleeding Academic Research Consortium (BARC) bleeding events included: Bleeding (defined by BARC type 3 or 5), bleeding (defined by BARC type 2, 3, or 5), and any bleeding (defined as the composite of BARC type 1, 2, 3, or 5), where increases in BARC type indicate worse outcome. Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consultation; Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation; Type 3: Overt bleeding plus hemoglobin drop of 3 to ≤5 g/dL (3a), ≥5 g/dl (3b), and intracranial hemorrhage (3c) Type 5: Fatal bleeding
Time Frame
Day 1 to 12 months postdose
Title
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Description
The main efficacy endpoints were defined as the composite of cardiovascular death (ARC), stroke (protocol defined), systemic embolic event (SEE), myocardial infarction (MI), or definite stent thrombosis.
Time Frame
Day 1 to 12 months postdose
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Description
Treatment-emergent adverse events (TEAEs) in >1.0% of participants were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug.
Time Frame
Day 1 to 30 days after the last dose
Title
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Description
Study drug-related treatment-emergent adverse events (TEAEs) (experienced by 2 or more participants) were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug and were found to be related to treatment by the Investigator.
Time Frame
Day 1 to 30 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Oral anticoagulant (OAC) indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting. Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage. Successful PCI definition: The success of a PCI procedure is defined by 2 interrelated components: angiographic findings, procedural / clinical outcomes as detailed below: Angiographic Success A minimum stenosis diameter of < 20% (as visually assessed by angiography - residual blockage or stenosis reduced to less than 20% of the artery's diameter). Sufficient enlargement of the lumen at the target site to improve coronary artery blood flow with final thrombolysis in myocardial infarction (TIMI) flow grade 3 (visually assessed by angiography), without occlusion of a significant side branch, flow-limiting dissection, distal embolization, or angiographic thrombus. Procedural Success No major in-hospital clinical complications(e.g. ongoing International Society on Thrombosis and Haemostasis [ISTH] major or clinical relevant non-major procedural bleeding at the time of randomization, stroke, emergency coronary artery bypass graft [CABG]). In summary, a clinically successful PCI requires both anatomic and procedural success along with relief of signs and/or symptoms of myocardial ischemia at the time of randomization. Exclusion Criteria: Bleeding risks or systemic conditions Known bleeding diathesis, including but not limited to, Uncontrolled active bleeding, encompassing both ISTH major and clinically relevant non-major bleeding, preceding randomization. Lesion or condition, if considered to be a significant risk for major bleeding. This may include but is not limited to: unresolved gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding (e.g. malignancies with metastasis), recent unresolved brain or spinal injury, recent brain, spinal or ophthalmic surgery, any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms (of more than 3.5 cm) or major intraspinal or intracerebral vascular abnormalities. Medication-related International normalized ratio (INR) > 2.5 (the participant can be reconsidered at a later time, but within 5 days of sheath removal). Contraindication to edoxaban, VKA, acetylsalicylic acid (ASA) and/or P2Y12 antagonists; Concomitant treatment with other antithrombotic agents, fibrinolytic therapy and chronic nonsteroidal anti-inflammatory drugs (NSAIDs). Concomitant conditions and therapies Critically ill or hemodynamically unstable subjects (at the time of randomization) including: cardiogenic shock or acute decompensated heart failure, with the requirement for vasopressor agents or inotropic support or mechanical support to support circulation respiratory failure requiring endotracheal intubation and mechanical ventilation. Any prior mechanical valvular prosthesis; Planned coronary or vascular intervention or major surgery within 12 months; Randomization must be deferred to the last stage in a multistep, multivessel PCI procedure; Moderate or severe mitral stenosis; Ischemic stroke within 2 weeks prior to randomization; Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥ 120 mmHg; End stage renal disease (ESRD) (CrCL < 15 mL/min or on dialysis); Known abnormal liver function prior to randomization (including hepatic disease or biochemical evidence of significant liver derangement known prior to randomization). Other exclusion criteria Any of the following abnormal local laboratory results prior to randomization: Platelet count < 50 x10^9/L Hemoglobin < 8 mg/dL Unable to provide written Informed Consent; Female participants of childbearing potential without using highly effective contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study). Females taking oral contraceptives should have been on therapy for at least three months. Adequate contraceptives include: Combined (estrogen and progestogen containing) oral, intravaginal, transdermal, hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence; Pregnant or breast-feeding participants; Assessment that the participant is not likely to comply with the study procedures or have complete follow-up; Participating in another clinical trial that potentially interferes with the current study; Previous randomization in this study; Active on prescription drug abuse and addiction; abuse of illicit substances (i.e. marijuana, cocaine, methamphetamine, heroin) and alcohol abuses during the last 12 months according to the judgement of the investigator; Life expectancy < 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Vranckx, MD
Organizational Affiliation
Hartcentrum Hasselt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Gotte, Prof., MD
Organizational Affiliation
Medizinische Klinik II
Official's Role
Study Chair
Facility Information:
Facility Name
Medizinische Universitaetsklinik Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
University Hospital Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Krankenhaus Hietzing
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
ASZ Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hopital Erasme
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Virga Jesse Jessa hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Cote Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Chru Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Metropole Savoie Hospital
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil Essonnes Cedex
ZIP/Postal Code
91106
Country
France
Facility Name
Hospital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
6001
Country
France
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris cedex 8
ZIP/Postal Code
75877
Country
France
Facility Name
Hôpital Rangueil, Service Cancérologie
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Clinique Vauban
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg • Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Kerckhoff Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Vivantes Klinikum im Friedrichshaim
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Charité Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Staedtische Kliniken Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
GFO Kliniken Bonn - St.-Marien-Hospital
City
Bonn
ZIP/Postal Code
53115
Country
Germany
Facility Name
Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
St. Johannes- Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg GmbH (UHZ)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin
City
Jena
ZIP/Postal Code
7747
Country
Germany
Facility Name
Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie
City
Leipzig
ZIP/Postal Code
4289
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Städtisches Klinikum Lüneburg
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum
City
München
ZIP/Postal Code
81379
Country
Germany
Facility Name
Universitätsklinikum Münster - Department für Kardiologie und Angiologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Universitäts Klinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Herzklinik Ulm
City
Ulm
ZIP/Postal Code
89077
Country
Germany
Facility Name
Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
St. Josefs-Hospital - Medizinische Klinik I, Kardiologie
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal - Herzzentrum
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
Állami Szívkórház
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Budai Irgalmasrendi Kht.
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Gottsegen György Országos Kardiológiai Intézet
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Kórház és Rendelőintézet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Békés Megyei Központi Kórház
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Győr
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pécsi Tudományegyetem
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudományegyetem
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Fejér Megyei Szent György Egyetemi Oktató Kórház
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Ospedale San Donato- ASL 8 Arezzo
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
AOU Materdomini, Magna Graecia University
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
ASL2 Chieti - SS Maria Annunziata
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
A.S.O.S. Croce e Carle Cuneo
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
AOU Sant'Anna
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Ospedale Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedali Riuniti di Foggia
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Asst Fatebenefratelli-Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
AOU Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
University Hospital Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Padova University Hospital
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Ospedale degli Infermi di Rivoli
City
Rivoli
ZIP/Postal Code
10098
Country
Italy
Facility Name
Policlinico Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Bolognini Hospital Seriate
City
Seriate
ZIP/Postal Code
24068
Country
Italy
Facility Name
"Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
U.O. Cardiologia Ospedale Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Daegu Catholic University Hospital
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Inje Univ. Ilsan Paik Hospital
City
Gyeonggi-do
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St.Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Gyeonggi-do
ZIP/Postal Code
431796
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
136-200
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Centre
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
SEOUL St.Maria
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136705
Country
Korea, Republic of
Facility Name
Lithuanian University of Health Sciences hospital
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda Seamen's Hospital
City
Klaipėda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital "Santariskiu Clinic"
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Republican Siauliai Hospital
City
Šiauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
St Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Radboud university medical center
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Maasstad Hospital
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
MC Haaglanden
City
The Hague
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca
City
Bielsko-Biala
ZIP/Postal Code
43-316
Country
Poland
Facility Name
MCSN AHoP
City
Chrzanów
ZIP/Postal Code
32-500
Country
Poland
Facility Name
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca
City
Dąbrowa Górnicza
ZIP/Postal Code
41-300
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego
City
Kraków
ZIP/Postal Code
31-302
Country
Poland
Facility Name
AHP IV DEP K-Kozle
City
Kędzierzyn-Koźle
ZIP/Postal Code
47-200
Country
Poland
Facility Name
Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca
City
Nysa
ZIP/Postal Code
48-300
Country
Poland
Facility Name
Clin-Medica OMC sp. z o.o. s.k.
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Nzoz Salus
City
Łódź
ZIP/Postal Code
91-302
Country
Poland
Facility Name
Hospital Garcia de Orta, EPE
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Facility Name
Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões
City
Coimbra
ZIP/Postal Code
3041 801
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Emergency County Hospital Baia Mare
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
"Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
University Hospital of Bucharest
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Saint John Emergency Hospital
City
Bucharest
ZIP/Postal Code
42122
Country
Romania
Facility Name
Oradea Emergency County Clinical Hospital
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Institutul de Boli Cardiovasculare Timisoara
City
Timişoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Emergency Institute of Cardiovascular Diseases and Transplantation
City
Târgu-Mureş
ZIP/Postal Code
540136
Country
Romania
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center -Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of CV Diseases Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute of Cardiovascular Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
General University Hospital of Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Granada
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Bellvitge University Hospital
City
L'Hospitalet de Llobregat
ZIP/Postal Code
8907
Country
Spain
Facility Name
Complejo Asistencial Universitario de León
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Clinica Universitaria San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital La Paz, Madrid
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
280471
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
HFR Freiburg - Kantonsspital Kardiologie
City
Fribourg
ZIP/Postal Code
1700
Country
Switzerland
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Hsinchu Mackay Memorial Hospital (HMMH)
City
Hsinchu
ZIP/Postal Code
30071
Country
Taiwan
Facility Name
Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
E-DA Hospital
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital (FEMH)
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
China Medical University Hospital (CMUH)
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Chi-Mei Medical Center (CMMC)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Cheng Hsin General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Cherkasy regional cardiological center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Chernihiv City Hospital #2
City
Chernihiv
ZIP/Postal Code
14034
Country
Ukraine
Facility Name
Chernivtsi Regional Clinical Cardiology Dispensary
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
CI "Dnipropetrovsk Joint Emergency Hospital"
City
Dnipropetrovsk
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
Communal Institution Dnepropetrovsk Regional Diagnostic Center
City
Dnipro
ZIP/Postal Code
49060
Country
Ukraine
Facility Name
Ivano-Frankivsk Central City Clinical Hospital
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Kharkiv City Clinical Hospital #8
City
Kharkiv
ZIP/Postal Code
61178
Country
Ukraine
Facility Name
Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"
City
Kharkov
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
Khmelnytskyy regional hospital
City
Khmel'nyts'kyy
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Insititute of Heart of MoH Ukraine
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital#5
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital 4
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Oleksandrivska Kiyv City Clinical Hospital
City
Kyiv
ZIP/Postal Code
1601
Country
Ukraine
Facility Name
Communal Institution of Kyiv Regional Rada
City
Kyiv
ZIP/Postal Code
4107
Country
Ukraine
Facility Name
Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center
City
L'viv
ZIP/Postal Code
79015
Country
Ukraine
Facility Name
Lutsk City Hospital
City
Luts'k
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Nikolaev Regional Clinical Hospital
City
Nikolayev
ZIP/Postal Code
54003
Country
Ukraine
Facility Name
Odessa Regional Hospital, Cardiosurgery Center
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Communal Institution Rivne Regional Clinical Hospital
City
Rivne
ZIP/Postal Code
33007
Country
Ukraine
Facility Name
Communal Institution of Sumy Regional Rada
City
Sumy
ZIP/Postal Code
40031
Country
Ukraine
Facility Name
Transcarpathian Regional Clinical Cardiology Clinic
City
Uzhhorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"
City
Vinnytsya
ZIP/Postal Code
21000
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Hospital n.a. Pyrogov
City
Vinnytsya
ZIP/Postal Code
21000
Country
Ukraine
Facility Name
Zaporizhzhia Regional cardiology dispensary
City
Zaporizhzhia
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Golden Jubilee Hospital
City
Clydebank
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
Southern Health and Social Care Trust
City
Portadown
ZIP/Postal Code
BT63 5QQ
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
33098470
Citation
Goette A, Eckardt L, Valgimigli M, Lewalter T, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Tijssen JG, Vranckx P. Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis. Clin Res Cardiol. 2021 Jun;110(6):831-840. doi: 10.1007/s00392-020-01760-4. Epub 2020 Oct 24.
Results Reference
derived
PubMed Identifier
31492505
Citation
Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.
Results Reference
derived
PubMed Identifier
29421002
Citation
Vranckx P, Lewalter T, Valgimigli M, Tijssen JG, Reimitz PE, Eckardt L, Lanz HJ, Zierhut W, Smolnik R, Goette A. Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial. Am Heart J. 2018 Feb;196:105-112. doi: 10.1016/j.ahj.2017.10.009. Epub 2017 Oct 23.
Results Reference
derived

Learn more about this trial

Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

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