AzTrials
AzTrials

Atrial FibrillationPhase 3ENTRUST-AF-PCINCT02866175

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

A Phase 3 study testing Edoxaban, Clopidogrel and Prasugrel in people with Atrial Fibrillation, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 200 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Edoxaban, Clopidogrel and Prasugrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,506 participants
Where
200 sitesin 18 countries
Study dates
24 Feb 2017to 6 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

200 sites in 18 countries.

200 sites in 18 countries

Germany31 sites

  • University Hospital Aachen

    Aachen, 52074

  • Universitäts-Herzzentrum Freiburg • Bad Krozingen

    Bad Krozingen, 79189

  • Kerckhoff Klinik

    Bad Nauheim, 61231

  • Vivantes Klinikum im Friedrichshaim

    Berlin, 10249

  • Charité Benjamin Franklin

    Berlin, 12203

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

    Berlin, 13353

  • Staedtische Kliniken Bielefeld

    Bielefeld, 33604

  • GFO Kliniken Bonn - St.-Marien-Hospital

    Bonn, 53115

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

    Bonn, 53127

  • Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie

    Coburg, 96450

  • St. Johannes- Hospital

    Dortmund, 44137

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

    Düsseldorf, 40225

  • Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I

    Freiburg im Breisgau, 79106

  • Universitäres Herzzentrum Hamburg GmbH (UHZ)

    Hamburg, 20246

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

    Heidelberg, 69120

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

    Homburg, 66421

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

    Jena, 7747

  • Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie

    Leipzig, 4289

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Städtisches Klinikum Lüneburg

    Lüneburg, 21339

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

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

    München, 81379

  • Universitätsklinikum Münster - Department für Kardiologie und Angiologie

    Münster, 48149

  • St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II

    Paderborn, 33098

  • Universitätsmedizin Rostock

    Rostock, 18057

  • Universitäts Klinikum Tübingen

    Tübingen, 72076

  • Herzklinik Ulm

    Ulm, 89077

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

    Ulm, 89081

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

    Villingen-Schwenningen, 78052

  • St. Josefs-Hospital - Medizinische Klinik I, Kardiologie

    Wiesbaden, 65189

  • HELIOS Klinikum Wuppertal - Herzzentrum

    Wuppertal, 42117

Other trials in Germany

Ukraine27 sites

  • Cherkasy regional cardiological center

    Cherkasy, 18009

  • Chernihiv City Hospital #2

    Chernihiv, 14034

  • Chernivtsi Regional Clinical Cardiology Dispensary

    Chernivtsi, 58013

  • Communal Institution Dnepropetrovsk Regional Diagnostic Center

    Dnipro, 49060

  • CI "Dnipropetrovsk Joint Emergency Hospital"

    Dnipropetrovsk, 49006

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, 76018

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

    Kharkiv, 61000

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

    Kharkiv, 61039

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

    Kharkiv, 61058

  • Kharkiv City Clinical Hospital #8

    Kharkiv, 61178

  • Khmelnytskyy regional hospital

    Khmelnytskyi, 29000

  • Insititute of Heart of MoH Ukraine

    Kyiv, 02660

  • Kyiv City Clinical Hospital#5

    Kyiv, 03115

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

    Kyiv, 03151

  • Kyiv City Clinical Hospital 4

    Kyiv, 04112

  • Oleksandrivska Kiyv City Clinical Hospital

    Kyiv, 1601

  • Communal Institution of Kyiv Regional Rada

    Kyiv, 4107

  • Lutsk City Hospital

    Lutsk, 43024

  • Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center

    Lviv, 79015

  • Nikolaev Regional Clinical Hospital

    Nikolayev, 54003

  • Odessa Regional Hospital, Cardiosurgery Center

    Odesa, 65025

  • Communal Institution Rivne Regional Clinical Hospital

    Rivne, 33007

  • Communal Institution of Sumy Regional Rada

    Sumy, 40031

  • Transcarpathian Regional Clinical Cardiology Clinic

    Uzhhorod, 88018

  • Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"

    Vinnytsia, 21000

  • Vinnytsya Regional Clinical Hospital n.a. Pyrogov

    Vinnytsia, 21000

  • Zaporizhzhia Regional cardiology dispensary

    Zaporizhzhya, 69000

Other trials in Ukraine

Italy22 sites

  • Ospedale San Donato- ASL 8 Arezzo

    Arezzo, 52100

  • Policlinico di Bari

    Bari, 70124

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

    Bologna, 40133

  • AOU Materdomini, Magna Graecia University

    Catanzaro, 88100

  • ASL2 Chieti - SS Maria Annunziata

    Chieti, 66100

  • A.S.O.S. Croce e Carle Cuneo

    Cuneo, 12100

  • AOU Sant'Anna

    Ferrara, 44124

  • Ospedale Careggi

    Florence, 50134

  • Ospedali Riuniti di Foggia

    Foggia, 71122

  • Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco

    Lecco, 23900

  • Asst Fatebenefratelli-Sacco

    Milan, 20157

  • AOU Policlinico di Modena

    Modena, 41124

  • University Hospital Federico II

    Naples, 80131

  • Padova University Hospital

    Padova, 35128

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

  • Ospedale degli Infermi

    Rimini, 47923

  • Ospedale degli Infermi di Rivoli

    Rivoli, 10098

  • Policlinico Agostino Gemelli

    Roma, 00168

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

    Rome, 00152

  • Bolognini Hospital Seriate

    Seriate, 24068

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

    Terni, 05100

  • U.O. Cardiologia Ospedale Borgo Trento

    Verona, 37126

Other trials in Italy

South Korea16 sites

  • Pusan National University Hospital

    Busan, 49241

  • Daegu Catholic University Hospital

    Daegu, 42472

  • Chonnam National University Hospital

    Gwangju, 61469

  • Inje Univ. Ilsan Paik Hospital

    Gyeonggi-do, 10380

  • The Catholic University of Korea St.Vincent's Hospital

    Gyeonggi-do, 16247

  • Hallym University Sacred Heart Hospital

    Gyeonggi-do, 431796

  • Inha University Hospital

    Incheon, 400-711

  • Chonbuk National University Hospital

    Jeonju, 561-712

  • Seoul National University Bundang Hospital

    Seongnam, 136-200

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Samsung Medical Centre

    Seoul, 06351

  • SEOUL St.Maria

    Seoul, 06591

  • Boramae Medical Center

    Seoul, 07061

  • Korea University Guro Hospital

    Seoul, 08308

  • Korea University Anam Hospital

    Seoul, 136705

Other trials in South Korea

Spain16 sites

  • General University Hospital of Alicante

    Alicante, 3010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 8916

  • Complejo Hospitalario Universitario de Granada

    Granada, 18014

  • Bellvitge University Hospital

    L'Hospitalet de Llobregat, 8907

  • Complejo Asistencial Universitario de León

    León, 24071

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Clinica Universitaria San Carlos

    Madrid, 28040

  • Hospital La Paz, Madrid

    Madrid, 28046

  • Hospital Universitario 12 de Octubre

    Madrid, 280471

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Hungary12 sites

  • Állami Szívkórház

    Balatonfüred, 8230

  • Budai Irgalmasrendi Kht.

    Budapest, 1023

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096

  • Bajcsy-Zsilinszky Kórház és Rendelőintézet

    Budapest, 1106

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1134

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9023

  • Békés Megyei Központi Kórház

    Gyula, 5700

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

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem

    Pécs, 7624

  • Szegedi Tudományegyetem

    Szeged, 6725

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000

Other trials in Hungary

Poland11 sites

  • II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca

    Bielsko-Biala, 43-316

  • MCSN AHoP

    Chrzanów, 32-500

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

    Dąbrowa Górnicza, 41-300

  • AHP IV DEP K-Kozle

    Kędzierzyn-Koźle, 47-200

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

    Krakow, 31-302

  • Nzoz Salus

    Lodz, 91-302

  • Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca

    Nysa, 48-300

  • Clin-Medica OMC sp. z o.o. s.k.

    Skierniewice, 96-100

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

    Tychy, 43-100

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

    Warsaw, 04-628

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

    Warsaw, 04-628

Other trials in Poland

France10 sites

  • University Hospital of Angers

    Angers, 49933

  • Hopital Cote Basque

    Bayonne, 64100

  • Chru Jean Minjoz

    Besançon, 25030

  • Metropole Savoie Hospital

    Chambéry, 73000

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

  • Hospital Henri Mondor

    Créteil, 94000

  • CHU de Nice

    Nice, 6001

  • Hôpital Bichat - Claude Bernard

    Paris, 75877

  • Hôpital Rangueil, Service Cancérologie

    Toulouse, 31400

  • Clinique Vauban

    Valenciennes, 59300

Other trials in France

Taiwan10 sites

  • Hsinchu Mackay Memorial Hospital (HMMH)

    Hsinchu, 30071

  • Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung City, 807

  • E-DA Hospital

    Kaohsiung City, 824

  • Far Eastern Memorial Hospital (FEMH)

    New Taipei City, 220

  • China Medical University Hospital (CMUH)

    Taichung, 404

  • Chi-Mei Medical Center (CMMC)

    Tainan, 704

  • National Cheng Kung University Hospital

    Tainan, 704

  • Cheng Hsin General Hospital

    Taipei, 112

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang-Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Belgium7 sites

  • ASZ Aalst

    Aalst, 9300

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • AZ St Jan

    Bruges, 8000

  • Hopital Erasme

    Brussels, 1070

  • University Hospital Antwerp

    Edegem, 2650

  • Virga Jesse Jessa hospital

    Hasselt, 3500

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Romania7 sites

  • Emergency County Hospital Baia Mare

    Baia Mare, 430031

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

    Bucharest, 022328

  • University Hospital of Bucharest

    Bucharest, 050098

  • Saint John Emergency Hospital

    Bucharest, 42122

  • Oradea Emergency County Clinical Hospital

    Oradea, 410169

  • Emergency Institute of Cardiovascular Diseases and Transplantation

    Târgu Mureş, 540136

  • Institutul de Boli Cardiovasculare Timisoara

    Timișoara, 300310

Other trials in Romania

Portugal6 sites

  • Hospital Garcia de Orta, EPE

    Almada, 2805-267

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

    Carnaxide, 2790-134

  • Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

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

    Coimbra, 3041 801

  • Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta

    Lisbon, 1169-024

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

    Lisbon, 1649-035

Other trials in Portugal

United Kingdom6 sites

  • Blackpool Victoria Hospital

    Blackpool, Lancashire, FY3 8NR

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Golden Jubilee Hospital

    Clydebank, G81 4DY

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB

  • Southern Health and Social Care Trust

    Portadown, BT63 5QQ

Other trials in United Kingdom

Serbia5 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Center -Zvezdara

    Belgrade, 11000

  • Institute of CV Diseases Clinical Center of Serbia

    Belgrade, 11000

  • Institute of Cardiovascular Diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Austria4 sites

  • Medizinische Universitaetsklinik Graz

    Graz, 8036

  • University Hospital Innsbruck

    Innsbruck, 6020

  • Krankenhaus Hietzing

    Vienna, 1130

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Lithuania4 sites

  • Lithuanian University of Health Sciences hospital

    Kaunas, 50009

  • Klaipeda Seamen's Hospital

    Klaipėda, 92288

  • Republican Siauliai Hospital

    Šiauliai, 76231

  • Vilnius University Hospital "Santariskiu Clinic"

    Vilnius, 08661

Other trials in Lithuania

Netherlands4 sites

  • St Antonius Hospital

    Nieuwegein, 3435 CM

  • Radboud university medical center

    Nijmegen, 6525 GA

  • Maasstad Hospital

    Rotterdam, 3079 DZ

  • MC Haaglanden

    The Hague, 2512 VA

Other trials in Netherlands

Switzerland2 sites

  • HFR Freiburg - Kantonsspital Kardiologie

    Fribourg, 1700

  • Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

About this study

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.

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.

Being tested
Edoxaban, Clopidogrel, Prasugrel, Ticagrelor, Vitamin K antagonist
Keywords
percutaneous intervention, vitamin K antagonist
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

    Also called Savaysa

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

  • ClopidogrelDrug

    Also called Plavix

    Clopidogrel 75 mg once-daily

  • PrasugrelDrug

    Also called Effient

    prasugrel 5mg or 10 mg once-daily

  • TicagrelorDrug

    ticagrelor 90 mg twice-daily

  • Vitamin K antagonistDrug

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

Study groups in NCT02866175
Study groupRoleWhat they receive
Edoxaban RegimenExperimentalParticipants 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.
Receives: Drug: Edoxaban; Drug: Clopidogrel; Drug: Prasugrel; Drug: Ticagrelor
Vitamin K Antagonist RegimenActive 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.
Receives: Drug: Clopidogrel; Drug: Prasugrel; Drug: Ticagrelor; Drug: Vitamin K antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 to 12 months postdose

Secondary outcomes (6)

  1. 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.

    Measured: Day 1 to 12 months postdose

  2. 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)

    Measured: Day 1 to 12 months postdose

  3. 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

    Measured: Day 1 to 12 months postdose

  4. 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.

    Measured: Day 1 to 12 months postdose

  5. 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.

    Measured: Day 1 to 30 days after the last dose

  6. 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.

    Measured: Day 1 to 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start24 Feb 2017
  3. Primary completion6 Jun 2019
  4. Study completion6 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866175
Sponsor's protocol ID
DSE-EDO-01-15-EU
Other IDs
2016-002683-14, 2016
Acronym
ENTRUST-AF-PCI
Status last verified
Apr 2020
First submitted
10 Aug 2016
Last updated
6 May 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 33098470

  • 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.

    PubMed 31492505

  • 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.

    PubMed 29421002

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Edoxaban, Clopidogrel and Prasugrel in people with Atrial Fibrillation, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 200 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in Germany, Ukraine, Italy, South Korea, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Day 1 to 12 months postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866175, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.

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