Clinical trial NCT02866175: Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: percutaneous intervention
vitamin K antagonist
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-08-15
Enrollment: 1506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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,

  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.

Primary outcomes:
measure: 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
timeFrame: Day 1 to 12 months postdose
Secondary outcomes:
measure: 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
timeFrame: Day 1 to 12 months postdose
measure: 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
timeFrame: Day 1 to 12 months postdose
measure: 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
timeFrame: Day 1 to 12 months postdose
measure: Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
timeFrame: Day 1 to 12 months postdose
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
timeFrame: Day 1 to 30 days after the last dose
measure: 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
timeFrame: Day 1 to 30 days after the last dose
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universitaetsklinik Graz
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Wien
country: Austria
facility: Wilhelminenspital
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brugge
country: Belgium
facility: AZ St Jan
city: Brussel
country: Belgium
facility: Hopital Erasme
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Hasselt
country: Belgium
facility: Virga Jesse Jessa hospital
city: Roeselare
country: Belgium
facility: AZ Delta
city: Angers
country: France
facility: University Hospital of Angers
city: Bayonne
country: France
facility: Hopital Cote Basque
city: Besancon
country: France
facility: Chru Jean Minjoz
city: Chambery
country: France
facility: Metropole Savoie Hospital
city: Corbeil Essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
city: Creteil
country: France
facility: Hospital Henri Mondor
city: Nice
country: France
facility: CHU de Nice
city: Paris cedex 8
country: France
facility: Hôpital Bichat - Claude Bernard
city: Toulouse
country: France
facility: Hôpital Rangueil, Service Cancérologie
city: Valenciennes
country: France
facility: Clinique Vauban
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshaim
city: Berlin
country: Germany
facility: Charité Benjamin Franklin
city: Berlin
country: Germany
facility: Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie
city: Bielefeld
country: Germany
facility: Staedtische Kliniken Bielefeld
city: Bonn
country: Germany
facility: GFO Kliniken Bonn - St.-Marien-Hospital
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)
city: Coburg
country: Germany
facility: Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie
city: Dortmund
country: Germany
facility: St. Johannes- Hospital
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin
city: Jena
country: Germany
facility: Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Lüneburg
country: Germany
facility: Städtisches Klinikum Lüneburg
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: München
country: Germany
facility: Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Department für Kardiologie und Angiologie
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Tübingen
country: Germany
facility: Universitäts Klinikum Tübingen
city: Ulm
country: Germany
facility: Herzklinik Ulm
city: Ulm
country: Germany
facility: Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital - Medizinische Klinik I, Kardiologie
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal - Herzzentrum
city: Balatonfüred
country: Hungary
facility: Állami Szívkórház
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kht.
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Győr
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Oktató Kórház
city: Arezzo
country: Italy
facility: Ospedale San Donato- ASL 8 Arezzo
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bologna
country: Italy
facility: Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica
city: Catanzaro
country: Italy
facility: AOU Materdomini, Magna Graecia University
city: Chieti
country: Italy
facility: ASL2 Chieti - SS Maria Annunziata
city: Cuneo
country: Italy
facility: A.S.O.S. Croce e Carle Cuneo
city: Ferrara
country: Italy
facility: AOU Sant'Anna
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Foggia
country: Italy
facility: Ospedali Riuniti di Foggia
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco
city: Milano
country: Italy
facility: Asst Fatebenefratelli-Sacco
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Napoli
country: Italy
facility: University Hospital Federico II
city: Padova
country: Italy
facility: Padova University Hospital
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Rivoli
country: Italy
facility: Ospedale degli Infermi di Rivoli
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Rome
country: Italy
facility: S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica
city: Seriate
country: Italy
facility: Bolognini Hospital Seriate
city: Terni
country: Italy
facility: "Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni
city: Verona
country: Italy
facility: U.O. Cardiologia Ospedale Borgo Trento
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Inje Univ. Ilsan Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St.Vincent's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre
city: Seoul
country: Korea, Republic of
facility: SEOUL St.Maria
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences hospital
city: Klaipėda
country: Lithuania
facility: Klaipeda Seamen's Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital "Santariskiu Clinic"
city: Šiauliai
country: Lithuania
facility: Republican Siauliai Hospital
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: The Hague
country: Netherlands
facility: MC Haaglanden
city: Bielsko-Biala
country: Poland
facility: II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca
city: Chrzanów
country: Poland
facility: MCSN AHoP
city: Dąbrowa Górnicza
country: Poland
facility: III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego
city: Kędzierzyn-Koźle
country: Poland
facility: AHP IV DEP K-Kozle
city: Nysa
country: Poland
facility: Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca
city: Skierniewice
country: Poland
facility: Clin-Medica OMC sp. z o.o. s.k.
city: Tychy
country: Poland
facility: X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca
city: Warsaw
country: Poland
facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej
city: Warszawa
country: Poland
facility: Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca
city: Łódź
country: Poland
facility: Nzoz Salus
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, EPE
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
city: Baia Mare
country: Romania
facility: Emergency County Hospital Baia Mare
city: Bucharest
country: Romania
facility: "Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases
city: Bucharest
country: Romania
facility: University Hospital of Bucharest
city: Bucharest
country: Romania
facility: Saint John Emergency Hospital
city: Oradea
country: Romania
facility: Oradea Emergency County Clinical Hospital
city: Timişoara
country: Romania
facility: Institutul de Boli Cardiovasculare Timisoara
city: Târgu-Mureş
country: Romania
facility: Emergency Institute of Cardiovascular Diseases and Transplantation
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center -Zvezdara
city: Belgrade
country: Serbia
facility: Institute of CV Diseases Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases of Vojvodina
city: Alicante
country: Spain
facility: General University Hospital of Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario de Granada
city: L'Hospitalet de Llobregat
country: Spain
facility: Bellvitge University Hospital
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Clinica Universitaria San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Fribourg
country: Switzerland
facility: HFR Freiburg - Kantonsspital Kardiologie
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Hsinchu
country: Taiwan
facility: Hsinchu Mackay Memorial Hospital (HMMH)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital (FEMH)
city: Taichung
country: Taiwan
facility: China Medical University Hospital (CMUH)
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center (CMMC)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital
city: Cherkasy
country: Ukraine
facility: Cherkasy regional cardiological center
city: Chernihiv
country: Ukraine
facility: Chernihiv City Hospital #2
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Cardiology Dispensary
city: Dnipropetrovsk
country: Ukraine
facility: CI "Dnipropetrovsk Joint Emergency Hospital"
city: Dnipro
country: Ukraine
facility: Communal Institution Dnepropetrovsk Regional Diagnostic Center
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine
city: Kharkiv
country: Ukraine
facility: Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"
city: Kharkiv
country: Ukraine
facility: Kharkiv City Clinical Hospital #8
city: Kharkov
country: Ukraine
facility: Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"
city: Khmel'nyts'kyy
country: Ukraine
facility: Khmelnytskyy regional hospital
city: Kyiv
country: Ukraine
facility: Insititute of Heart of MoH Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital#5
city: Kyiv
country: Ukraine
facility: State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital 4
city: Kyiv
country: Ukraine
facility: Oleksandrivska Kiyv City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Communal Institution of Kyiv Regional Rada
city: L'viv
country: Ukraine
facility: Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center
city: Luts'k
country: Ukraine
facility: Lutsk City Hospital
city: Nikolayev
country: Ukraine
facility: Nikolaev Regional Clinical Hospital
city: Odessa
country: Ukraine
facility: Odessa Regional Hospital, Cardiosurgery Center
city: Rivne
country: Ukraine
facility: Communal Institution Rivne Regional Clinical Hospital
city: Sumy
country: Ukraine
facility: Communal Institution of Sumy Regional Rada
city: Uzhhorod
country: Ukraine
facility: Transcarpathian Regional Clinical Cardiology Clinic
city: Vinnytsya
country: Ukraine
facility: Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Regional Clinical Hospital n.a. Pyrogov
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhia Regional cardiology dispensary
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: Lancashire
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Clydebank
country: United Kingdom
facility: Golden Jubilee Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: Portadown
country: United Kingdom
facility: Southern Health and Social Care Trust
Study officials:
affiliation: Hartcentrum Hasselt
name: Pascal Vranckx, MD
role: STUDY_CHAIR
affiliation: Medizinische Klinik II
name: Andreas Gotte, Prof., MD
role: STUDY_CHAIR
References:
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.
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