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

NCT ID: NCT02866175

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1506 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-24
• Study Completion Date: 2019-06-06

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Edoxaban Regimen

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.

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg once-daily

Prasugrel

Intervention Type: DRUG

prasugrel 5mg or 10 mg once-daily

Ticagrelor

Intervention Type: DRUG

ticagrelor 90 mg twice-daily

Vitamin K Antagonist Regimen

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.

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Clopidogrel 75 mg once-daily

Prasugrel

Intervention Type: DRUG

prasugrel 5mg or 10 mg once-daily

Ticagrelor

Intervention Type: DRUG

ticagrelor 90 mg twice-daily

Vitamin K antagonist

Intervention Type: DRUG

VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive

Interventions

Edoxaban

Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects

Intervention Type: DRUG

Clopidogrel

Clopidogrel 75 mg once-daily

Intervention Type: DRUG

Prasugrel

prasugrel 5mg or 10 mg once-daily

Intervention Type: DRUG

Ticagrelor

ticagrelor 90 mg twice-daily

Intervention Type: DRUG

Vitamin K antagonist

VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive

Intervention Type: DRUG

Other Intervention Names

Savaysa; Plavix; Effient

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).

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Vranckx, MD

Role: STUDY_CHAIR

Hartcentrum Hasselt

Andreas Gotte, Prof., MD

Role: STUDY_CHAIR

Medizinische Klinik II

Locations

Medizinische Universitaetsklinik Graz

Graz, , Austria

University Hospital Innsbruck

Innsbruck, , Austria

Krankenhaus Hietzing

Vienna, , Austria

Wilhelminenspital

Vienna, , Austria

ASZ Aalst

Aalst, , Belgium

Imelda Ziekenhuis

Bonheiden, , Belgium

AZ St Jan

Bruges, , Belgium

Hopital Erasme

Brussels, , Belgium

University Hospital Antwerp

Edegem, , Belgium

Virga Jesse Jessa hospital

Hasselt, , Belgium

AZ Delta

Roeselare, , Belgium

University Hospital of Angers

Angers, , France

Hopital Cote Basque

Bayonne, , France

Chru Jean Minjoz

Besançon, , France

Metropole Savoie Hospital

Chambéry, , France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Hospital Henri Mondor

Créteil, , France

CHU de Nice

Nice, , France

Hôpital Bichat - Claude Bernard

Paris, , France

Hôpital Rangueil, Service Cancérologie

Toulouse, , France

Clinique Vauban

Valenciennes, , France

University Hospital Aachen

Aachen, , Germany

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Bad Krozingen, , Germany

Kerckhoff Klinik

Bad Nauheim, , Germany

Vivantes Klinikum im Friedrichshaim

Berlin, , Germany

Charité Benjamin Franklin

Berlin, , Germany

Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie

Berlin, , Germany

Staedtische Kliniken Bielefeld

Bielefeld, , Germany

GFO Kliniken Bonn - St.-Marien-Hospital

Bonn, , Germany

Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)

Bonn, , Germany

Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie

Coburg, , Germany

St. Johannes- Hospital

Dortmund, , Germany

Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie

Düsseldorf, , Germany

Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I

Freiburg im Breisgau, , Germany

Universitäres Herzzentrum Hamburg GmbH (UHZ)

Hamburg, , Germany

Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)

Heidelberg, , Germany

Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin

Homburg, , Germany

Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin

Jena, , Germany

Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie

Leipzig, , Germany

Klinikum Ludwigshafen

Ludwigshafen, , Germany

Städtisches Klinikum Lüneburg

Lüneburg, , Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, , Germany

Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum

München, , Germany

Universitätsklinikum Münster - Department für Kardiologie und Angiologie

Münster, , Germany

St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II

Paderborn, , Germany

Universitätsmedizin Rostock

Rostock, , Germany

Universitäts Klinikum Tübingen

Tübingen, , Germany

Herzklinik Ulm

Ulm, , Germany

Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II

Ulm, , Germany

Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin

Villingen-Schwenningen, , Germany

St. Josefs-Hospital - Medizinische Klinik I, Kardiologie

Wiesbaden, , Germany

HELIOS Klinikum Wuppertal - Herzzentrum

Wuppertal, , Germany

Állami Szívkórház

Balatonfüred, , Hungary

Budai Irgalmasrendi Kht.

Budapest, , Hungary

Gottsegen György Országos Kardiológiai Intézet

Budapest, , Hungary

Bajcsy-Zsilinszky Kórház és Rendelőintézet

Budapest, , Hungary

Magyar Honvédség Egészségügyi Központ

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Békés Megyei Központi Kórház

Gyula, , Hungary

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

Nyíregyháza, , Hungary

Pécsi Tudományegyetem

Pécs, , Hungary

Szegedi Tudományegyetem

Szeged, , Hungary

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, , Hungary

Ospedale San Donato- ASL 8 Arezzo

Arezzo, , Italy

Policlinico di Bari

Bari, , Italy

Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica

Bologna, , Italy

AOU Materdomini, Magna Graecia University

Catanzaro, , Italy

ASL2 Chieti - SS Maria Annunziata

Chieti, , Italy

A.S.O.S. Croce e Carle Cuneo

Cuneo, , Italy

AOU Sant'Anna

Ferrara, , Italy

Ospedale Careggi

Florence, , Italy

Ospedali Riuniti di Foggia

Foggia, , Italy

Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco

Lecco, , Italy

Asst Fatebenefratelli-Sacco

Milan, , Italy

AOU Policlinico di Modena

Modena, , Italy

University Hospital Federico II

Napoli, , Italy

Padova University Hospital

Padua, , Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Ospedale degli Infermi

Rimini, , Italy

Ospedale degli Infermi di Rivoli

Rivoli, , Italy

Policlinico Agostino Gemelli

Roma, , Italy

S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica

Rome, , Italy

Bolognini Hospital Seriate

Seriate, , Italy

"Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni

Terni, , Italy

U.O. Cardiologia Ospedale Borgo Trento

Verona, , Italy

Lithuanian University of Health Sciences hospital

Kaunas, , Lithuania

Klaipeda Seamen's Hospital

Klaipėda, , Lithuania

Republican Siauliai Hospital

Šiauliai, , Lithuania

Vilnius University Hospital "Santariskiu Clinic"

Vilnius, , Lithuania

St Antonius Hospital

Nieuwegein, , Netherlands

Radboud university medical center

Nijmegen, , Netherlands

Maasstad Hospital

Rotterdam, , Netherlands

MC Haaglanden

The Hague, , Netherlands

II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca

Bielsko-Biala, , Poland

MCSN AHoP

Chrzanów, , Poland

III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca

Dąbrowa Górnicza, , Poland

AHP IV DEP K-Kozle

Kędzierzyn-Koźle, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego

Krakow, , Poland

Nzoz Salus

Lodz, , Poland

Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca

Nysa, , Poland

Clin-Medica OMC sp. z o.o. s.k.

Skierniewice, , Poland

X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca

Tychy, , Poland

Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca

Warsaw, , Poland

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej

Warsaw, , Poland

Hospital Garcia de Orta, EPE

Almada, , Portugal

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

Carnaxide, , Portugal

Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, , Portugal

Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões

Coimbra, , Portugal

Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta

Lisbon, , Portugal

Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

Lisbon, , Portugal

Emergency County Hospital Baia Mare

Baia Mare, , Romania

"Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases

Bucharest, , Romania

University Hospital of Bucharest

Bucharest, , Romania

Saint John Emergency Hospital

Bucharest, , Romania

Oradea Emergency County Clinical Hospital

Oradea, , Romania

Emergency Institute of Cardiovascular Diseases and Transplantation

Târgu Mureş, , Romania

Institutul de Boli Cardiovasculare Timisoara

Timișoara, , Romania

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Hospital Center -Zvezdara

Belgrade, , Serbia

Institute of CV Diseases Clinical Center of Serbia

Belgrade, , Serbia

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Pusan National University Hospital

Busan, , South Korea

Daegu Catholic University Hospital

Daegu, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Inje Univ. Ilsan Paik Hospital

Gyeonggi-do, , South Korea

The Catholic University of Korea St.Vincent's Hospital

Gyeonggi-do, , South Korea

Hallym University Sacred Heart Hospital

Gyeonggi-do, , South Korea

Inha University Hospital

Incheon, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Samsung Medical Centre

Seoul, , South Korea

SEOUL St.Maria

Seoul, , South Korea

Boramae Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

General University Hospital of Alicante

Alicante, , Spain

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Complejo Hospitalario Universitario de Granada

Granada, , Spain

Bellvitge University Hospital

L'Hospitalet de Llobregat, , Spain

Complejo Asistencial Universitario de León

León, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Clinica Universitaria San Carlos

Madrid, , Spain

Hospital La Paz, Madrid

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Hospital Universitario Virgen de La Victoria

Málaga, , Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Álvaro Cunqueiro

Vigo, , Spain

HFR Freiburg - Kantonsspital Kardiologie

Fribourg, , Switzerland

Cardiocentro Ticino

Lugano, , Switzerland

Hsinchu Mackay Memorial Hospital (HMMH)

Hsinchu, , Taiwan

Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, , Taiwan

E-DA Hospital

Kaohsiung City, , Taiwan

Far Eastern Memorial Hospital (FEMH)

New Taipei City, , Taiwan

China Medical University Hospital (CMUH)

Taichung, , Taiwan

Chi-Mei Medical Center (CMMC)

Tainan City, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Cheng Hsin General Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang-Gung Memorial Hospital

Taoyuan District, , Taiwan

Cherkasy regional cardiological center

Cherkasy, , Ukraine

Chernihiv City Hospital #2

Chernihiv, , Ukraine

Chernivtsi Regional Clinical Cardiology Dispensary

Chernivtsi, , Ukraine

Communal Institution Dnepropetrovsk Regional Diagnostic Center

Dnipro, , Ukraine

CI "Dnipropetrovsk Joint Emergency Hospital"

Dnipropetrovsk, , Ukraine

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, , Ukraine

Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"

Kharkiv, , Ukraine

L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine

Kharkiv, , Ukraine

Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"

Kharkiv, , Ukraine

Kharkiv City Clinical Hospital #8

Kharkiv, , Ukraine

Khmelnytskyy regional hospital

Khmelnytskyi, , Ukraine

Insititute of Heart of MoH Ukraine

Kyiv, , Ukraine

Kyiv City Clinical Hospital#5

Kyiv, , Ukraine

State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'

Kyiv, , Ukraine

Kyiv City Clinical Hospital 4

Kyiv, , Ukraine

Oleksandrivska Kiyv City Clinical Hospital

Kyiv, , Ukraine

Communal Institution of Kyiv Regional Rada

Kyiv, , Ukraine

Lutsk City Hospital

Lutsk, , Ukraine

Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center

Lviv, , Ukraine

Nikolaev Regional Clinical Hospital

Nikolayev, , Ukraine

Odessa Regional Hospital, Cardiosurgery Center

Odesa, , Ukraine

Communal Institution Rivne Regional Clinical Hospital

Rivne, , Ukraine

Communal Institution of Sumy Regional Rada

Sumy, , Ukraine

Transcarpathian Regional Clinical Cardiology Clinic

Uzhhorod, , Ukraine

Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"

Vinnytsia, , Ukraine

Vinnytsya Regional Clinical Hospital n.a. Pyrogov

Vinnytsia, , Ukraine

Zaporizhzhia Regional cardiology dispensary

Zaporizhzhia, , Ukraine

Blackpool Victoria Hospital

Blackpool, Lancashire, United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

Golden Jubilee Hospital

Clydebank, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Altnagelvin Area Hospital

Londonderry, , United Kingdom

Southern Health and Social Care Trust

Portadown, , United Kingdom

Countries

Austria; Belgium; France; Germany; Hungary; Italy; Lithuania; Netherlands; Poland; Portugal; Romania; Serbia; South Korea; Spain; Switzerland; Taiwan; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33098470 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31492505 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29421002 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-002683-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DSE-EDO-01-15-EU

Identifier Type: -

Identifier Source: org_study_id