Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
- Registration Number
- NCT02942576
- Lead Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 632
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Edoxaban-based regimen Edoxaban Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period. VKA-based regimen VKA-Based Regimen VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Major Bleeding (International Society on Thrombosis and Hemostasis [ISTH]) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) Day 1 to Day 90 Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of \>2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
Number of Participants Who Experienced the Composite of All-cause Death, Stroke (VARC-2), and Major Bleeding (ISTH) in the Edoxaban Group Compared With Vitamin K Antagonist (VKA) Group in Participants Undergoing Catheter Ablation (Adjudicated Data) Day 1 to Day 90 Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction \>24 hours (h), duration of neurological dysfunction \<24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death.
Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of \>2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experienced the Composite of All-cause Death, Stroke (Alternative), and Major Bleeding (ISTH) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) Day 1 to Day 90 An alternative definition characterized stroke (ischemic, hemorrhagic, or undetermined) as an abrupt onset, over minutes to hours, of a focal neurological deficit in the distribution of a single brain artery that was not due to an identifiable nonvascular cause (ie, brain tumor or trauma), and that either lasted at least 24 hours or resulted in death within 24 hours of onset.
Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of \>2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.Number of Participants Who Experienced the Composite of Stroke (VARC-2), Systemic Embolic Events (SEE), and Cardiovascular (CV) Mortality in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data) Day 1 to Day 90 Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction \>24 hours (h), duration of neurological dysfunction \<24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death.
SEE was defined as an arterial embolism resulting in clinical ischemia, excluding the central nervous system, coronary, and pulmonary arterial circulation.
CV mortality was defined as cardiac or vascular death according to Academic Research Consortium.
Trial Locations
- Locations (74)
Klinika Intensywnej Terapii Kardiologicznej
🇵🇱Łódź, Poland
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Pineta Grande Hospital
🇮🇹Castel Volturno, Italy
Ospedale dell'Angelo
🇮🇹Mestre, Italy
Istituto di Cura cittè di Pavia
🇮🇹Pavia, Italy
Deutsches Herzk. Universitätsklinikum Tübingen Medizinische Klinik III. Kardiologie
🇩🇪Tübingen, Germany
Korea University Anam Hospital
🇰🇷Seoul, Seoungbuk-gu, Korea, Republic of
Pecs University Clinical Center
🇭🇺Pécs, Hungary
Ospedale San Donato
🇮🇹Arezzo, Italy
Azienda Ospedaliera di Piacenza "Ospedale Guglielmo d Saliceto"
🇮🇹Piacenza, Italy
Hospital Universitario San Juan de Alicante
🇪🇸San Juan de Alicante, Spain
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
FN Brno
🇨🇿Brno, Czechia
Samsung Medical Center
🇰🇷Seoul, Gangnam-gu, Korea, Republic of
IKEM
🇨🇿Prague, Czechia
University Hospital Motol - Cardiology
🇨🇿Prague, Czechia
ASST Vimercate
🇮🇹Monza, Italy
Ospedale Ecclesiastico "Miulli"
🇮🇹Sant'Eramo, Italy
Klinikum Coburg GmbH II.Med.Klinik
🇩🇪Coburg, Germany
Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
🇩🇪Wuerzburg, Germany
Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika
🇭🇺Debrecen, Hungary
Szegedi Tudományegyetem II. Belgyógyászati Klnika és Kardiológiai Központ
🇭🇺Szeged, Hungary
Zala Megyei Szent Rafael Kórház Kardiológia Osztály
🇭🇺Zalaegerszeg, Hungary
Oddział Kliniczny Kardiologii SUM Katedra Kardiologii
🇵🇱Zabrze, Poland
Taichung Veterans General Hospital (VGH-TC)
🇨🇳Taichung City, Taiwan
FN Kralovske Vinohrady
🇨🇿Praha, Czechia
VFN v Praze II. Interní klinika - Kardiologie a angiologie
🇨🇿Praha, Czechia
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Policlinico Casilino
🇮🇹Roma, Italy
University Clinic Duesseldorf Clinic for Cardiology, Pneumology and Angiology
🇩🇪Duesseldorf, Germany
Arcispedale Sant'Anna
🇮🇹Cona, Italy
University of Calgary
🇨🇦Calgary, Canada
University Hospital - Szpital Uniwersytecki
🇵🇱Kraków, Poland
Oddzial Kardiologii Szpital Grochowski im. dr R. Masztaka SPZOZ
🇵🇱Warszawa, Poland
Hospital General Universitario
🇪🇸Alicante, Spain
University Hospital of Heidelberg Clinic of Cardiology, Angiology and Pneumology
🇩🇪Heidelberg, Germany
Herzzentrum Leipzig - Universitätsklinik Abteilung für Rhythmologie
🇩🇪Leipzig, Germany
Universita' degli Studi Catanzaro
🇮🇹Catanzaro, Italy
Azienda USL Toscana
🇮🇹Firenze, Italy
Charité Universitätsmedizin Berlin - CVK Medizinische Klinik m.S. Kardiologie
🇩🇪Berlin, Germany
Montreal Heart Institute
🇨🇦Montréal, Canada
Ospedale della Misericordia
🇮🇹Grosseto, Italy
Ospedale Santo Cuore
🇮🇹Negrar, Italy
Samodzielny Publiczny Szpital Kliniczny Nr 4 Klinika Kardiologii
🇵🇱Lublin, Poland
Blackpool Teaching Hospitals NHS
🇬🇧Blackpool, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Hospital Clinic Cardiologia
🇪🇸Barcelona, Spain
Yonsei University Severance Hospital
🇰🇷Seoul, Seodaemun-Gu, Korea, Republic of
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Papworth Hospital NHS Trust
🇬🇧Cambridge, United Kingdom
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Universitätsmedizin Rostock Zentrum für Innere Medizin I, Kardiologie
🇩🇪Rostock, Germany
Erasme Hospital
🇧🇪Brussels, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Hamilton Health Sciences/McMaster University
🇨🇦Hamilton, Canada
UZ Brussel
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Canada
Universitäts Herzzentrum Freiburg-Bad Krozingen Klinik für Kardiologie und Angiologie II
🇩🇪Bad Krozingen, Germany
St. Anne's University Hospital Brno, International Clinical Research Center
🇨🇿Brno, Czechia
Masarykova nemocnice - Kardiologie Krajská zdravotní, a.s.
🇨🇿Ústí nad Labem, Czechia
Klinikum Bielefeld Klinik für Kardiologie/internist. Intensivmedizin
🇩🇪Bielefeld, Germany
Klinik für Innere Medizin I
🇩🇪Dortmund, Germany
Universitäres Herzzentrum Hamburg Kardiologie mit Schwerpunkt Elektrophysiologie
🇩🇪Hamburg, Germany
Univ. of Muenster.Cardiovascular Medicine
🇩🇪Muenster, Germany
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
🇭🇺Budapest, Hungary
Magyar Honvédség Egészségügyi Központ Kardiológiai Osztály
🇭🇺Budapest, Hungary
Largo Agostino Gemelli
🇮🇹Rome, Italy
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital del Mar
🇪🇸Barcelona, Spain
Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan
China Medical University Hospital
🇨🇳Taichung City, Taiwan
King's College Hospital
🇬🇧London, United Kingdom