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

NCT ID: NCT02942576

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 632 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2018-09-24

Brief 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.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

Edoxaban-based regimen

Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

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

VKA-based regimen

VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)

Group Type: ACTIVE_COMPARATOR

VKA-Based Regimen

Intervention Type: DRUG

Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea.

VKA-Based Regimen

Intervention Type: DRUG

Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.

VKA-Based Regimen

Intervention Type: DRUG

Dosed at INR levels. Standard of Care treatment in France.

VKA-Based Regimen

Intervention Type: DRUG

Dosed at INR levels. Standard of Care treatment in Spain.

Interventions

Edoxaban

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

Intervention Type: DRUG

VKA-Based Regimen

Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea.

Intervention Type: DRUG

VKA-Based Regimen

Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.

Intervention Type: DRUG

VKA-Based Regimen

Dosed at INR levels. Standard of Care treatment in France.

Intervention Type: DRUG

VKA-Based Regimen

Dosed at INR levels. Standard of Care treatment in Spain.

Intervention Type: DRUG

Other Intervention Names

Lixiana; Warfarin; Phenprogamma; Phenprocoumon; Previscan; Fluindione; Sintrom; Acenocoumarol

Eligibility Criteria

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 any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary).
• Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
• Signed informed consent form (ICF).

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 months prior to randomization.
• Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
• Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
• Subject has signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Hemostasis (ISTH), or conditions associated with high risk of bleeding
• Subjects with any contraindication for anticoagulant agents.

• 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

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

ZNA Middelheim

Antwerp, , Belgium

Erasme Hospital

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

University of Calgary

Calgary, , Canada

Hamilton Health Sciences/McMaster University

Hamilton, , Canada

Montreal Heart Institute

Montreal, , Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, , Canada

FN Brno

Brno, , Czechia

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

Brno, , Czechia

FN Kralovske Vinohrady

Prague, , Czechia

VFN v Praze II. Interní klinika - Kardiologie a angiologie

Prague, , Czechia

IKEM

Prague, , Czechia

University Hospital Motol - Cardiology

Prague, , Czechia

Masarykova nemocnice - Kardiologie Krajská zdravotní, a.s.

Ústí nad Labem, , Czechia

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

Bad Krozingen, , Germany

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

Berlin, , Germany

Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin

Bielefeld, , Germany

Klinikum Coburg GmbH II.Med.Klinik

Coburg, , Germany

Klinik für Innere Medizin I

Dortmund, , Germany

University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology

Düsseldorf, , Germany

Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie

Hamburg, , Germany

University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology

Heidelberg, , Germany

Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie

Leipzig, , Germany

Univ. of Muenster.Cardiovascular Medicine

Münster, , Germany

Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie

Rostock, , Germany

Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I

Würzburg, , Germany

Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

Budapest, , Hungary

Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály

Budapest, , Hungary

Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika

Debrecen, , Hungary

Pecs University Clinical Center

Pécs, , Hungary

Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ

Szeged, , Hungary

Zala Megyei Szent Rafael Kórház Kardiológia Osztály

Zalaegerszeg, , Hungary

Ospedale San Donato

Arezzo, , Italy

Pineta Grande Hospital

Castel Volturno, , Italy

Universita' degli Studi Catanzaro

Catanzaro, , Italy

Arcispedale Sant'Anna

Cona, , Italy

Azienda USL Toscana

Florence, , Italy

Ospedale della Misericordia

Grosseto, , Italy

Ospedale dell'Angelo

Mestre, , Italy

ASST Vimercate

Monza, , Italy

Ospedale Santo Cuore

Negrar, , Italy

Istituto di Cura cittè di Pavia

Pavia, , Italy

Azienda Ospedaliera di Piacenza "Ospedale Guglielmo d Saliceto"

Piacenza, , Italy

Policlinico Casilino

Roma, , Italy

Largo Agostino Gemelli

Rome, , Italy

Ospedale Ecclesiastico "Miulli"

Sant'Eramo, , Italy

University Hospital - Szpital Uniwersytecki

Krakow, , Poland

Klinika Intensywnej Terapii Kardiologicznej

Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii

Lublin, , Poland

Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ

Warsaw, , Poland

Oddział Kliniczny Kardiologii SUM Katedra Kardiologii

Zabrze, , Poland

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Yonsei University Severance Hospital

Seoul, Seodaemun-Gu, South Korea

Korea University Anam Hospital

Seoul, Seoungbuk-gu, South Korea

Asan Medical Center

Seoul, , South Korea

Hospital General Universitario

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Clinic Cardiologia

Barcelona, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario San Juan de Alicante

Sant Joan d'Alacant, , Spain

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital (VGH-TC)

Taichung, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Blackpool Teaching Hospitals NHS

Blackpool, , United Kingdom

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Papworth Hospital NHS Trust

Cambridge, , United Kingdom

Leeds General Infirmary

Leeds, , United Kingdom

King's College Hospital

London, , United Kingdom

Nottingham City Hospital

Nottingham, , United Kingdom

Countries

Belgium; Canada; Czechia; Germany; Hungary; Italy; Poland; South Korea; Spain; Taiwan; United Kingdom

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-003069-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DSE-EDO-01-16-EU

Identifier Type: -

Identifier Source: org_study_id