Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02348723
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : November 14, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Warfarin Drug: Dabigatran Etexilate 150mg Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)
Actual Study Start Date : April 28, 2015
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : November 14, 2016


Arm Intervention/treatment
Experimental: Dabigatran Etexilate 150mg
Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)
Drug: Dabigatran Etexilate 150mg
Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)

Active Comparator: Warfarin
Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0
Drug: Warfarin
Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0




Primary Outcome Measures :
  1. Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) [ Time Frame: 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 :
  1. Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA) [ Time Frame: 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 presented


  2. Incidence of Minor Bleeding Events [ Time Frame: 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)


  3. Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy [ Time Frame: 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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patients aged >= 18 years.
  • Patients eligible for treatment with dabigatran etexilate 150 mg b.i.d. according to local label.
  • Treatment naïve patients or patients on oral anticoagulant treatment with a Vitamin K Antagonist (VKA), dabigatran etexilate, rivaroxaban, apixaban or edoxaban.
  • Patient with paroxysmal or persistent NVAF with a planned catheter ablation for AF unless it is performed an investigational ablation technique.
  • AF must have been documented at least once either by ECG, Holter monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac defibrillator read outs within 24 months prior to screening (Visit 1).
  • The patient must be able to give informed consent in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations.

Exclusion criteria:

  • Patients with permanent AF.
  • Patients with AF felt to be secondary to an obvious reversible cause such as, but not limited to, an acute myocardial infarction, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis.
  • Patients with Left Atrium (LA) size >= 60 mm
  • Patients with contraindications to systemic anticoagulation with heparin, warfarin or dabigatran etexilate
  • Patients with a known allergy to warfarin tablets and it excipients or to dabigatran etexilate or its excipients
  • Mechanical or biological heart valve prosthesis
  • Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
  • Stroke within 1 month prior to screening visit
  • Major surgery per investigator judgement within the previous month prior to screening.
  • Patient has received an organ transplant or is on a waiting list for an organ transplant
  • History of intracranial haemorrhage, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding
  • Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated (e.g. by surgery).
  • Major bleeding episode (ISTH definition) one month prior to the screening visit.
  • Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention)
  • Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 10^9/L) at screening
  • Recent malignancy or radiation therapy (<=6 months prior to screening) unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months
  • Active liver disease as indicated by at least one of the following:

    -- Prior and persistent alanine aminotransferase or Aspartate transaminase or alkaline phosphatase >3x upper limit of normal and/or -- Known active hepatitis C and/or -- Known active hepatitis B and/or -- Known active hepatitis A

  • Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic/myelosuppressive therapy.
  • Pre-menopausal (last menstruation <=1 year prior to screening) who:

    • Are pregnant or breast-feeding or plan to become pregnant during study or
    • Are not surgically sterile or
    • Are of child bearing potential and not practising two acceptable method of birth control, or do not plan to continue practising an acceptable method of birth control throughout the trial
  • Patients who have participated in another trial with an investigational drug or device within the past 30 days preceding the screening visit or are participating in another trial (patients participating in an observational study only will not be excluded)
  • Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease and/or subjects who are institutionalised due to official or court orders and/or vulnerable subjects who are dependent on the Sponsor or the Investigator or the site, or patients who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348723


Locations
Hide Hide 87 study locations
Layout table for location information
United States, Arkansas
Arkansas Cardiology, PA
Little Rock, Arkansas, United States, 72205
United States, California
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
University of California
Sacramento, California, United States, 95817
Mercy Medical Group, a service of Dignity Health Medical Foundation
Sacramento, California, United States, 95819
University of California
San Francisco, California, United States, 94143
United States, Florida
Southwest Florida Research, LLC
Naples, Florida, United States, 34102
University of South Florida
Tampa, Florida, United States, 33606
United States, Indiana
Elkhart General Healthcare System
Elkhart, Indiana, United States, 46514
United States, Louisiana
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Missouri
St. Louis Heart and Vascular, P.C.
Saint Louis, Missouri, United States, 63136
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
University at Buffalo, The State University of New York
Buffalo, New York, United States, 14203
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104-5068
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
University of Tennessee Methodist Physicians
Memphis, Tennessee, United States, 38104
United States, Texas
North Texas Heart Center
Dallas, Texas, United States, 75231
St Luke's Health Baylor College of Medicine Med Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Washington
Providence Regional Medical Center
Everett, Washington, United States, 98201
Belgium
Bonheiden - HOSP Imelda
Bonheiden, Belgium, 2820
Brussels - UNIV UZ Brussel
Brussel, Belgium, 1090
UNIV UZ Gent
Gent, Belgium, 9000
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
Antwerpen - HOSP ZNA Middelheim - Pneumo
Middelheim, Belgium, 2020
Brussels - HOSP Europe (Ste-Elisabeth)
Ukkel, Belgium, 1180
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada, V8T 1Z4
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Quebec
CHUS Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
IUCPQ (Laval University)
Quebec, Canada, G1V 4G5
France
HOP Nord Michallon
La Tronche, France, 38700
HOP Timone
Marseille, France, 13005
CLI Nouvelles Cliniques Nantaises,Cardio,Nantes Cedex 2
Nantes, France, 44000
HOP Salpêtrière, Cardio, Paris
Paris cedex 13, France, 75013
HOP Européen G. Pompidou
Paris, France, 75015
HOP Haut-Lévêque
Pessac, France, 33604
HOP CHU Nancy Brabois, Cardiologie
Vandoeuvre les Nancy, France, 54511
Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, Germany, 10967
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, Germany, 37075
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Universitätsklinikum Köln (AöR)
Köln, Germany, 50937
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Universitätsklinikum Ulm
Ulm, Germany, 89081
Italy
Ospedale Generale Regionale "Miulli"
Acquaviva Delle Fonti (BA), Italy, 70021
A.S.O.S. Croce e Carle
Cuneo, Italy, 12100
Osp.dell'Angelo
Mestre-Venezia, Italy, 30174
Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20132
Centro Cardiologico Monzino-IRCCS
Milano, Italy, 20138
Policlinico Casilino U.O. Cardiologia
Roma, Italy, 00169
Japan
Anjo-kosei Hospital
Aichi, Anjo, Japan, 446-8602
Nagoya City East Medical Center
Aichi, Nagoya, Japan, 464-8547
Nagoya University Hospital
Aichi, Nagoya, Japan, 466-8560
Japanese Red Cross Nagoya Daini Hospital
Aichi, Nagoya, Japan, 466-8650
Hirosaki University Hospital
Aomori, Hirosaki, Japan, 036-8563
New Tokyo Heart Clinic
Chiba, Matsudo, Japan, 271-0077
Shonan Kamakura General Hospital
Kanagawa, Kamakura, Japan, 247-8533
Sakurabashi Watanabe Hospital
Osaka, Osaka, Japan, 530-0001
Nippon Medical School Hospital
Tokyo, Bunkyo-Ku, Japan, 113-8603
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, Japan, 193-0998
Netherlands
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091AC
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Russian Federation
Heart&Vessels Diseases,Cardiol&Cardiovas.SurgeryDep,Kamerovo
Kemerovo, Russian Federation, 650002
Instit.of Surgery na Vishnevskiy,Treatm.of comp.arrhythm.dep
Moscow, Russian Federation, 117997
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
Saint Petersburg, Russian Federation, 199 106
North-Westrn Fed.med.res.cntr,Almazov Interven.arrhythmo.dep
St. Petersburg, Russian Federation, 197341
Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
Tyumen, Russian Federation, 625026
Yaroslavl Regional Clin. Hospital, Dept. Endocrinology
Yaroslavl, Russian Federation, 150062
Spain
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital La Paz
Madrid, Spain, 28046
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital Álvaro Cunqueiro
Vigo (Pontevedra), Spain, 36312
United Kingdom
Royal Bournemouth and Christchurch Hospital
Bournemouth, United Kingdom, BH7 7DW
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Papworth Hospital
Cambridge, United Kingdom, CB23 3RE
Golden Jubilee National Hospital, Clydebank
Clydebank, United Kingdom, G81 4DY
Castle Hill Hopsital
Cottingham, United Kingdom, HU16 5JQ
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
St Bartholomew's Hospital
London, United Kingdom, EC1A 4NP
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02348723    
Other Study ID Numbers: 1160.204
2014-003890-40 ( EudraCT Number )
First Posted: January 28, 2015    Key Record Dates
Results First Posted: November 14, 2017
Last Update Posted: January 29, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action