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Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

Primary Purpose

Atrial Fibrillation, Thromboembolism

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dabigatran
placebo
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring dabigatran

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • paroxysmal AF undergoing catheter ablation
  • CHA2DS2-VASc score <= 1
  • informed consent

Exclusion Criteria:

  • persistent AF
  • CHA2DS2-VASc score > 2
  • prior CVA
  • prior atnicoagulant
  • severe HF
  • abnormal liver or renal function
  • history of severe bleeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Short Group

    Conventional Group

    Arm Description

    The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

    The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.

    Outcomes

    Primary Outcome Measures

    The rate of thromboembolic events

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2014
    Last Updated
    December 9, 2014
    Sponsor
    Korea University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02313584
    Brief Title
    Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Thromboembolism
    Keywords
    dabigatran

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    464 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Short Group
    Arm Type
    Active Comparator
    Arm Description
    The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
    Arm Title
    Conventional Group
    Arm Type
    Placebo Comparator
    Arm Description
    The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation.
    Intervention Type
    Drug
    Intervention Name(s)
    dabigatran
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    The rate of thromboembolic events
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: paroxysmal AF undergoing catheter ablation CHA2DS2-VASc score <= 1 informed consent Exclusion Criteria: persistent AF CHA2DS2-VASc score > 2 prior CVA prior atnicoagulant severe HF abnormal liver or renal function history of severe bleeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Young-Hoon Kim
    Phone
    82-2-920-6700
    Email
    yhkmd@unitel.co.kr

    12. IPD Sharing Statement

    Learn more about this trial

    Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

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