Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 231 for:    warfarin AND International

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

Tracking Information
First Submitted Date  ICMJE January 27, 2015
First Posted Date  ICMJE January 28, 2015
Results First Submitted Date  ICMJE October 16, 2017
Results First Posted Date  ICMJE November 14, 2017
Last Update Posted Date January 29, 2018
Actual Study Start Date  ICMJE April 28, 2015
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
The incidence of Major Bleeding Events according to the ISTH definition [ Time Frame: during ablation and up 2 months post ablation ]
Change History Complete list of historical versions of study NCT02348723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • 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
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2015)
  • Stroke/SE/TIA events. [ Time Frame: during ablation and up 2 months post ablation ]
  • Minor bleeding events. [ Time Frame: during ablation and up 2 months post ablation ]
  • A composite of major bleeding events and thromboembolic events (Stroke, SE and TIA). [ Time Frame: during ablation and up 2 months post ablation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
Official Title  ICMJE Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Warfarin
    Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0
  • Drug: Dabigatran Etexilate 150mg
    Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)
Study Arms  ICMJE
  • Experimental: Dabigatran Etexilate 150mg
    Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)
    Intervention: Drug: Dabigatran Etexilate 150mg
  • Active Comparator: Warfarin
    Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0
    Intervention: Drug: Warfarin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
678
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2015)
724
Actual Study Completion Date  ICMJE November 14, 2016
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Italy,   Japan,   Netherlands,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02348723
Other Study ID Numbers  ICMJE 1160.204
2014-003890-40 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP