Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT02348723
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.
Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.
It is not intended to assess confirmatory hypothesis, this is an exploratory study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran Etexilate 150mg Dabigatran Etexilate 150mg Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID) Warfarin Warfarin Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0
- Primary Outcome Measures
Name Time Method Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) during and up to 2 months post-ablation Major bleeds were defined according to the ISTH definition of a major bleed, as follows
* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or
* Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or
* Fatal bleed
These are based on adjudicated data (blinded evaluation)
Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented.
- Secondary Outcome Measures
Name Time Method Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA) during and up to 2 months post-ablation Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.
Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.
Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.
These are based on adjudicated data (blinded evaluation).
Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presentedIncidence of Minor Bleeding Events during and up to 2 months post-ablation Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented.
These are based on adjudicated data (blinded evaluation)Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy during and up to 2 months post-ablation Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented.
These are based on adjudicated data (blinded evaluation)
Trial Locations
- Locations (86)
Mercy Medical Group, a service of Dignity Health Medical Foundation
🇺🇸Sacramento, California, United States
Southwest Florida Research, LLC
🇺🇸Naples, Florida, United States
University of California
🇺🇸San Francisco, California, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Elkhart General Healthcare System
🇺🇸Elkhart, Indiana, United States
University of South Florida
🇺🇸Tampa, Florida, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
St. Louis Heart and Vascular, P.C.
🇺🇸Saint Louis, Missouri, United States
University at Buffalo, The State University of New York
🇺🇸Buffalo, New York, United States
CHUS Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
CLI Nouvelles Cliniques Nantaises,Cardio,Nantes Cedex 2
🇫🇷Nantes, France
HOP Salpêtrière, Cardio, Paris
🇫🇷Paris cedex 13, France
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milano, Italy
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
🇩🇪Göttingen, Germany
Hirosaki University Hospital
🇯🇵Aomori, Hirosaki, Japan
New Tokyo Heart Clinic
🇯🇵Chiba, Matsudo, Japan
Instit.of Surgery na Vishnevskiy,Treatm.of comp.arrhythm.dep
🇷🇺Moscow, Russian Federation
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
🇷🇺Tyumen, Russian Federation
Hospital La Paz
🇪🇸Madrid, Spain
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Osp.dell'Angelo
🇮🇹Mestre-Venezia, Italy
Centro Cardiologico Monzino-IRCCS
🇮🇹Milano, Italy
HOP Européen G. Pompidou
🇫🇷Paris, France
Bonheiden - HOSP Imelda
🇧🇪Bonheiden, Belgium
Providence Regional Medical Center
🇺🇸Everett, Washington, United States
University of Tennessee Methodist Physicians
🇺🇸Memphis, Tennessee, United States
St Luke's Health Baylor College of Medicine Med Center
🇺🇸Houston, Texas, United States
Brussels - UNIV UZ Brussel
🇧🇪Brussel, Belgium
UNIV UZ Gent
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Antwerpen - HOSP ZNA Middelheim - Pneumo
🇧🇪Middelheim, Belgium
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
North Texas Heart Center
🇺🇸Dallas, Texas, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
HOP Nord Michallon
🇫🇷La Tronche, France
HOP Timone
🇫🇷Marseille, France
HOP Haut-Lévêque
🇫🇷Pessac, France
HOP CHU Nancy Brabois, Cardiologie
🇫🇷Vandoeuvre les Nancy, France
Brussels - HOSP Europe (Ste-Elisabeth)
🇧🇪Ukkel, Belgium
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
IUCPQ (Laval University)
🇨🇦Quebec, Canada
Vivantes Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Policlinico Casilino U.O. Cardiologia
🇮🇹Roma, Italy
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Ospedale Generale Regionale "Miulli"
🇮🇹Acquaviva Delle Fonti (BA), Italy
Anjo-kosei Hospital
🇯🇵Aichi, Anjo, Japan
Nagoya City East Medical Center
🇯🇵Aichi, Nagoya, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Aichi, Nagoya, Japan
A.S.O.S. Croce e Carle
🇮🇹Cuneo, Italy
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Shonan Kamakura General Hospital
🇯🇵Kanagawa, Kamakura, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Tokyo, Hachioji, Japan
Nagoya University Hospital
🇯🇵Aichi, Nagoya, Japan
Sakurabashi Watanabe Hospital
🇯🇵Osaka, Osaka, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-Ku, Japan
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
🇷🇺Saint Petersburg, Russian Federation
Royal Bournemouth and Christchurch Hospital
🇬🇧Bournemouth, United Kingdom
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Heart&Vessels Diseases,Cardiol&Cardiovas.SurgeryDep,Kamerovo
🇷🇺Kemerovo, Russian Federation
Hospital Álvaro Cunqueiro
🇪🇸Vigo (Pontevedra), Spain
Golden Jubilee National Hospital, Clydebank
🇬🇧Clydebank, United Kingdom
Castle Hill Hopsital
🇬🇧Cottingham, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Yaroslavl Regional Clin. Hospital, Dept. Endocrinology
🇷🇺Yaroslavl, Russian Federation
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
North-Westrn Fed.med.res.cntr,Almazov Interven.arrhythmo.dep
🇷🇺St. Petersburg, Russian Federation
Arkansas Cardiology, PA
🇺🇸Little Rock, Arkansas, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Victoria Cardiac Arrhythmia Trials Inc.
🇨🇦Victoria, British Columbia, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Mission Cardiovascular Research Institute
🇺🇸Fremont, California, United States