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



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2018
Start Date:April 28, 2015
End Date:November 14, 2016

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Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)

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.


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).
We found this trial at
22
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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9 Imeldalaan
Bonheiden, 2820
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Brooklyn, NY
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Buffalo, NY
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Dallas, Texas 75231
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Elkhart, Indiana 46514
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Everett, Washington 98201
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, TX
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Little Rock, Arkansas 72205
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Memphis, TN
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Naples, Florida 34102
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New Orleans, Louisiana 70112
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New Orleans, LA
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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949 University Avenue
Sacramento, California 95817
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Saint Louis, Missouri 63136
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Salt Lake City, Utah 84132
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San Francisco, California 94143
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475 Seaview Ave
Staten Island, New York 10305
(718) 226-9000
Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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