Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

Last updated: August 26, 2019
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Overall Status: Completed

Phase

3

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT02942576
DSE-EDO-01-16-EU
2016-003069-25
  • Ages > 18
  • All Genders

Study Summary

There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting]persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by anyelectrical tracing or a recording in the subject's medical records (e.g., medicalchart, hospital discharge summary).

  • Subject is eligible and is scheduled for either radio frequency (RF) or cryoballooncatheter ablation (both first and repeated procedure included).

  • Signed informed consent form (ICF).

Exclusion

Exclusion Criteria:

  • AF considered to be of a transient or reversible nature (such as in myocarditis,post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).

  • Subject post stroke, or with a systemic thromboembolic event within the past 6 monthsprior to randomization.

  • Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), leftventricle (LV), or aorta, or an intracardial mass.

  • Subject had a myocardial infarction (MI) within the 2 months prior to randomization orcoronary artery bypass graft (CABG) surgery within 3 months prior to therandomization.

  • Subject has signs of bleeding, history of clinically-relevant bleeding according toInternational Society on Thrombosis and Hemostasis (ISTH), or conditions associatedwith high risk of bleeding

  • Subjects with any contraindication for anticoagulant agents.

Study Design

Total Participants: 632
Study Start date:
March 21, 2017
Estimated Completion Date:
September 24, 2018

Connect with a study center

  • ZNA Middelheim

    Antwerpen, 2020
    Belgium

    Site Not Available

  • Erasme Hospital

    Brussels, 1070
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels, 1090
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • University of Calgary

    Calgary, T2N 4Z6
    Canada

    Site Not Available

  • Hamilton Health Sciences/McMaster University

    Hamilton, L8L 2X2
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montréal, H1T 1C8
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, J1H 5N4
    Canada

    Site Not Available

  • FN Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • St. Anne's University Hospital Brno, International Clinical Research Center

    Brno, 69691
    Czechia

    Site Not Available

  • IKEM

    Prague, 14021
    Czechia

    Site Not Available

  • University Hospital Motol - Cardiology

    Prague, 150 06
    Czechia

    Site Not Available

  • FN Kralovske Vinohrady

    Praha, 100 34
    Czechia

    Site Not Available

  • VFN v Praze II. Interní klinika - Kardiologie a angiologie

    Praha, 128 08
    Czechia

    Site Not Available

  • Masarykova nemocnice - Kardiologie Krajská zdravotní, a.s.

    Ústí nad Labem, 40113
    Czechia

    Site Not Available

  • Universitäts Herzzentrum Freiburg-Bad Krozingen Klinik für Kardiologie und Angiologie II

    Bad Krozingen, 79189
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin - CVK Medizinische Klinik m.S. Kardiologie

    Berlin, 13353
    Germany

    Site Not Available

  • Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin

    Bielefeld, 33604
    Germany

    Site Not Available

  • Klinikum Coburg GmbH II.Med.Klinik

    Coburg, 96450
    Germany

    Site Not Available

  • Klinik für Innere Medizin I

    Dortmund, 44137
    Germany

    Site Not Available

  • University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie

    Hamburg, 20251
    Germany

    Site Not Available

  • University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology

    Heidelberg, 69120
    Germany

    Site Not Available

  • Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie

    Leipzig, 04289
    Germany

    Site Not Available

  • Univ. of Muenster.Cardiovascular Medicine

    Muenster, 48149
    Germany

    Site Not Available

  • Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie

    Rostock, 18057
    Germany

    Site Not Available

  • Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály

    Budapest, 1134
    Hungary

    Site Not Available

  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122
    Hungary

    Site Not Available

  • Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika

    Debrecen, 4032
    Hungary

    Site Not Available

  • Pecs University Clinical Center

    Pécs, H 7624
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ

    Szeged, 6725
    Hungary

    Site Not Available

  • Zala Megyei Szent Rafael Kórház Kardiológia Osztály

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Ospedale San Donato

    Arezzo, 52100
    Italy

    Site Not Available

  • Pineta Grande Hospital

    Castel Volturno, 81030
    Italy

    Site Not Available

  • Universita' degli Studi Catanzaro

    Catanzaro, 88100
    Italy

    Site Not Available

  • Arcispedale Sant'Anna

    Cona, 44124
    Italy

    Site Not Available

  • Azienda USL Toscana

    Firenze, 50122
    Italy

    Site Not Available

  • Ospedale della Misericordia

    Grosseto, 58100
    Italy

    Site Not Available

  • Ospedale dell'Angelo

    Mestre, 30174
    Italy

    Site Not Available

  • ASST Vimercate

    Monza, 80082
    Italy

    Site Not Available

  • Ospedale Santo Cuore

    Negrar, 37024
    Italy

    Site Not Available

  • Istituto di Cura cittè di Pavia

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Piacenza "Ospedale Guglielmo d Saliceto"

    Piacenza, 29124
    Italy

    Site Not Available

  • Policlinico Casilino

    Roma, 00169
    Italy

    Site Not Available

  • Largo Agostino Gemelli

    Rome, 00168
    Italy

    Site Not Available

  • Ospedale Ecclesiastico "Miulli"

    Sant'Eramo, 70021
    Italy

    Site Not Available

  • Samsung Medical Center

    Seoul, Gangnam-gu 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Jongno-gu 03080
    Korea, Republic of

    Site Not Available

  • Yonsei University Severance Hospital

    Seoul, Seodaemun-Gu 03722
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, Seoungbuk-gu 02841
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • HagaZiekenhuis, Cardiology

    Den Haag, 2545 AA
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • St. Antonius Hospital

    Nieuwegein, 3435 CM
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Isala Cardiology

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • University Hospital - Szpital Uniwersytecki

    Kraków, 31-501
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii

    Lublin, 20-954
    Poland

    Site Not Available

  • Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ

    Warszawa, 04-073
    Poland

    Site Not Available

  • Oddział Kliniczny Kardiologii SUM Katedra Kardiologii

    Zabrze, 41-800
    Poland

    Site Not Available

  • Klinika Intensywnej Terapii Kardiologicznej

    Łódź, 92-213
    Poland

    Site Not Available

  • Hospital General Universitario

    Alicante, 03540
    Spain

    Site Not Available

  • Hospital Clinic Cardiologia

    Barcelona, 8036
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario San Juan de Alicante

    San Juan de Alicante, 03550
    Spain

    Site Not Available

  • Chang Gung Memorial Hospital

    Kaohsiung City, 83301
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung City, 40447
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital (VGH-TC)

    Taichung City, 40705
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Taoyuan City, 33305
    Taiwan

    Site Not Available

  • Blackpool Teaching Hospitals NHS

    Blackpool, FY3 8NR
    United Kingdom

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Papworth Hospital NHS Trust

    Cambridge, CB23 3RE
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leed, LS1 3EX
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

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