Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
ENTRUST-AF-PCI
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.
2 other identifiers
interventional
1,506
18 countries
200
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Feb 2017
200 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedStudy Start
First participant enrolled
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2019
CompletedResults Posted
Study results publicly available
May 6, 2020
CompletedMay 6, 2020
April 1, 2020
2.3 years
August 10, 2016
April 7, 2020
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1 to 12 months postdose
Secondary Outcomes (6)
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
Day 1 to 12 months postdose
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
Day 1 to 12 months postdose
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
Day 1 to 12 months postdose
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Day 1 to 12 months postdose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Day 1 to 30 days after the last dose
- +1 more secondary outcomes
Study Arms (2)
Edoxaban Regimen
EXPERIMENTALParticipants 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.
Vitamin K Antagonist Regimen
ACTIVE COMPARATORParticipants 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.
Interventions
Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects
Clopidogrel 75 mg once-daily
prasugrel 5mg or 10 mg once-daily
VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (200)
Medizinische Universitaetsklinik Graz
Graz, 8036, Austria
University Hospital Innsbruck
Innsbruck, 6020, Austria
Krankenhaus Hietzing
Vienna, 1130, Austria
Wilhelminenspital
Vienna, 1160, Austria
ASZ Aalst
Aalst, 9300, Belgium
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
AZ St Jan
Bruges, 8000, Belgium
Hopital Erasme
Brussels, 1070, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
Virga Jesse Jessa hospital
Hasselt, 3500, Belgium
AZ Delta
Roeselare, 8800, Belgium
University Hospital of Angers
Angers, 49933, France
Hopital Cote Basque
Bayonne, 64100, France
Chru Jean Minjoz
Besançon, 25030, France
Metropole Savoie Hospital
Chambéry, 73000, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
Hospital Henri Mondor
Créteil, 94000, France
CHU de Nice
Nice, 6001, France
Hôpital Bichat - Claude Bernard
Paris, 75877, France
Hôpital Rangueil, Service Cancérologie
Toulouse, 31400, France
Clinique Vauban
Valenciennes, 59300, France
University Hospital Aachen
Aachen, 52074, Germany
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen, 79189, Germany
Kerckhoff Klinik
Bad Nauheim, 61231, Germany
Vivantes Klinikum im Friedrichshaim
Berlin, 10249, Germany
Charité Benjamin Franklin
Berlin, 12203, Germany
Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, 13353, Germany
Staedtische Kliniken Bielefeld
Bielefeld, 33604, Germany
GFO Kliniken Bonn - St.-Marien-Hospital
Bonn, 53115, Germany
Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)
Bonn, 53127, Germany
Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie
Coburg, 96450, Germany
St. Johannes- Hospital
Dortmund, 44137, Germany
Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, 40225, Germany
Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I
Freiburg im Breisgau, 79106, Germany
Universitäres Herzzentrum Hamburg GmbH (UHZ)
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)
Heidelberg, 69120, Germany
Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin
Homburg, 66421, Germany
Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin
Jena, 7747, Germany
Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie
Leipzig, 4289, Germany
Klinikum Ludwigshafen
Ludwigshafen, 67063, Germany
Städtisches Klinikum Lüneburg
Lüneburg, 21339, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063, Germany
Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum
München, 81379, Germany
Universitätsklinikum Münster - Department für Kardiologie und Angiologie
Münster, 48149, Germany
St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II
Paderborn, 33098, Germany
Universitätsmedizin Rostock
Rostock, 18057, Germany
Universitäts Klinikum Tübingen
Tübingen, 72076, Germany
Herzklinik Ulm
Ulm, 89077, Germany
Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II
Ulm, 89081, Germany
Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin
Villingen-Schwenningen, 78052, Germany
St. Josefs-Hospital - Medizinische Klinik I, Kardiologie
Wiesbaden, 65189, Germany
HELIOS Klinikum Wuppertal - Herzzentrum
Wuppertal, 42117, Germany
Állami Szívkórház
Balatonfüred, 8230, Hungary
Budai Irgalmasrendi Kht.
Budapest, 1023, Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, 1096, Hungary
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest, 1106, Hungary
Magyar Honvédség Egészségügyi Központ
Budapest, 1134, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9023, Hungary
Békés Megyei Központi Kórház
Gyula, 5700, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem
Pécs, 7624, Hungary
Szegedi Tudományegyetem
Szeged, 6725, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000, Hungary
Ospedale San Donato- ASL 8 Arezzo
Arezzo, 52100, Italy
Policlinico di Bari
Bari, 70124, Italy
Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica
Bologna, 40133, Italy
AOU Materdomini, Magna Graecia University
Catanzaro, 88100, Italy
ASL2 Chieti - SS Maria Annunziata
Chieti, 66100, Italy
A.S.O.S. Croce e Carle Cuneo
Cuneo, 12100, Italy
AOU Sant'Anna
Ferrara, 44124, Italy
Ospedale Careggi
Florence, 50134, Italy
Ospedali Riuniti di Foggia
Foggia, 71122, Italy
Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco
Lecco, 23900, Italy
Asst Fatebenefratelli-Sacco
Milan, 20157, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
University Hospital Federico II
Napoli, 80131, Italy
Padova University Hospital
Padua, 35128, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126, Italy
Ospedale degli Infermi
Rimini, 47923, Italy
Ospedale degli Infermi di Rivoli
Rivoli, 10098, Italy
Policlinico Agostino Gemelli
Roma, 00168, Italy
S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica
Rome, 00152, Italy
Bolognini Hospital Seriate
Seriate, 24068, Italy
"Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni
Terni, 05100, Italy
U.O. Cardiologia Ospedale Borgo Trento
Verona, 37126, Italy
Lithuanian University of Health Sciences hospital
Kaunas, 50009, Lithuania
Klaipeda Seamen's Hospital
Klaipėda, 92288, Lithuania
Republican Siauliai Hospital
Šiauliai, 76231, Lithuania
Vilnius University Hospital "Santariskiu Clinic"
Vilnius, 08661, Lithuania
St Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
Radboud university medical center
Nijmegen, 6525 GA, Netherlands
Maasstad Hospital
Rotterdam, 3079 DZ, Netherlands
MC Haaglanden
The Hague, 2512 VA, Netherlands
II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca
Bielsko-Biala, 43-316, Poland
MCSN AHoP
Chrzanów, 32-500, Poland
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca
Dąbrowa Górnicza, 41-300, Poland
AHP IV DEP K-Kozle
Kędzierzyn-Koźle, 47-200, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego
Krakow, 31-302, Poland
Nzoz Salus
Lodz, 91-302, Poland
Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca
Nysa, 48-300, Poland
Clin-Medica OMC sp. z o.o. s.k.
Skierniewice, 96-100, Poland
X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca
Tychy, 43-100, Poland
Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca
Warsaw, 04-628, Poland
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej
Warsaw, 04-628, Poland
Hospital Garcia de Orta, EPE
Almada, 2805-267, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz
Carnaxide, 2790-134, Portugal
Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075, Portugal
Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões
Coimbra, 3041 801, Portugal
Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta
Lisbon, 1169-024, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Emergency County Hospital Baia Mare
Baia Mare, 430031, Romania
"Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases
Bucharest, 022328, Romania
University Hospital of Bucharest
Bucharest, 050098, Romania
Saint John Emergency Hospital
Bucharest, 42122, Romania
Oradea Emergency County Clinical Hospital
Oradea, 410169, Romania
Emergency Institute of Cardiovascular Diseases and Transplantation
Târgu Mureş, 540136, Romania
Institutul de Boli Cardiovasculare Timisoara
Timișoara, 300310, Romania
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Hospital Center -Zvezdara
Belgrade, 11000, Serbia
Institute of CV Diseases Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, 21204, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Pusan National University Hospital
Busan, 49241, South Korea
Daegu Catholic University Hospital
Daegu, 42472, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Inje Univ. Ilsan Paik Hospital
Gyeonggi-do, 10380, South Korea
The Catholic University of Korea St.Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, 431796, South Korea
Inha University Hospital
Incheon, 400-711, South Korea
Chonbuk National University Hospital
Jeonju, 561-712, South Korea
Seoul National University Bundang Hospital
Seongnam, 136-200, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Centre
Seoul, 06351, South Korea
SEOUL St.Maria
Seoul, 06591, South Korea
Boramae Medical Center
Seoul, 07061, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Korea University Anam Hospital
Seoul, 136705, South Korea
General University Hospital of Alicante
Alicante, 3010, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, 8916, Spain
Complejo Hospitalario Universitario de Granada
Granada, 18014, Spain
Bellvitge University Hospital
L'Hospitalet de Llobregat, 8907, Spain
Complejo Asistencial Universitario de León
León, 24071, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Clinica Universitaria San Carlos
Madrid, 28040, Spain
Hospital La Paz, Madrid
Madrid, 28046, Spain
Hospital Universitario 12 de Octubre
Madrid, 280471, Spain
Hospital Universitario Puerta de Hierro
Madrid, 28222, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47005, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
HFR Freiburg - Kantonsspital Kardiologie
Fribourg, 1700, Switzerland
Cardiocentro Ticino
Lugano, 6900, Switzerland
Hsinchu Mackay Memorial Hospital (HMMH)
Hsinchu, 30071, Taiwan
Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, 807, Taiwan
E-DA Hospital
Kaohsiung City, 824, Taiwan
Far Eastern Memorial Hospital (FEMH)
New Taipei City, 220, Taiwan
China Medical University Hospital (CMUH)
Taichung, 404, Taiwan
Chi-Mei Medical Center (CMMC)
Tainan, 704, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Cheng Hsin General Hospital
Taipei, 112, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang-Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Cherkasy regional cardiological center
Cherkasy, 18009, Ukraine
Chernihiv City Hospital #2
Chernihiv, 14034, Ukraine
Chernivtsi Regional Clinical Cardiology Dispensary
Chernivtsi, 58013, Ukraine
Communal Institution Dnepropetrovsk Regional Diagnostic Center
Dnipro, 49060, Ukraine
CI "Dnipropetrovsk Joint Emergency Hospital"
Dnipropetrovsk, 49006, Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, 76018, Ukraine
Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"
Kharkiv, 61000, Ukraine
L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine
Kharkiv, 61039, Ukraine
Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"
Kharkiv, 61058, Ukraine
Kharkiv City Clinical Hospital #8
Kharkiv, 61178, Ukraine
Khmelnytskyy regional hospital
Khmelnytskyi, 29000, Ukraine
Insititute of Heart of MoH Ukraine
Kyiv, 02660, Ukraine
Kyiv City Clinical Hospital#5
Kyiv, 03115, Ukraine
State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'
Kyiv, 03151, Ukraine
Kyiv City Clinical Hospital 4
Kyiv, 04112, Ukraine
Oleksandrivska Kiyv City Clinical Hospital
Kyiv, 1601, Ukraine
Communal Institution of Kyiv Regional Rada
Kyiv, 4107, Ukraine
Lutsk City Hospital
Lutsk, 43024, Ukraine
Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center
Lviv, 79015, Ukraine
Nikolaev Regional Clinical Hospital
Nikolayev, 54003, Ukraine
Odessa Regional Hospital, Cardiosurgery Center
Odesa, 65025, Ukraine
Communal Institution Rivne Regional Clinical Hospital
Rivne, 33007, Ukraine
Communal Institution of Sumy Regional Rada
Sumy, 40031, Ukraine
Transcarpathian Regional Clinical Cardiology Clinic
Uzhhorod, 88018, Ukraine
Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"
Vinnytsia, 21000, Ukraine
Vinnytsya Regional Clinical Hospital n.a. Pyrogov
Vinnytsia, 21000, Ukraine
Zaporizhzhia Regional cardiology dispensary
Zaporizhzhia, 69000, Ukraine
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Golden Jubilee Hospital
Clydebank, G81 4DY, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
Southern Health and Social Care Trust
Portadown, BT63 5QQ, United Kingdom
Related Publications (3)
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.
PMID: 33098470DERIVEDVranckx 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.
PMID: 31492505DERIVEDVranckx 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.
PMID: 29421002DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo, Inc.
Study Officials
- STUDY CHAIR
Pascal Vranckx, MD
Hartcentrum Hasselt
- STUDY CHAIR
Andreas Gotte, Prof., MD
Medizinische Klinik II
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 15, 2016
Study Start
February 24, 2017
Primary Completion
June 6, 2019
Study Completion
June 6, 2019
Last Updated
May 6, 2020
Results First Posted
May 6, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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/