Anticoagulation After RFCA (Reducible)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral anticoagulant
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1
Exclusion Criteria:
- Presence of intracardiac thrombus
Sites / Locations
- Seoul St Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1-month anticoagulation group
2-month anticoagulation group
Arm Description
Anticoagulation using warfarin or non-VKA oral anticoagulant for 1 month after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation.
Anticoagulation using warfarin or non-VKA oral anticoagulant for 2 months after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation
Outcomes
Primary Outcome Measures
Thromboembolic event
Composite of ischemic stroke, transient ischemic attack, or other systemic embolic events
Secondary Outcome Measures
Major bleeding
bleeding events that result in a reduction in hemoglobin level of at least 20 g per liter, transfusion of at least 2 units of blood, or symptomatic bleeding in a critical area or organ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03573037
Brief Title
Anticoagulation After RFCA
Acronym
Reducible
Official Title
Duration of Anticoagulation Therapy Following Catheter Ablation of Atrial Fibrillation; Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The anticoagulation therapy is needed when rhythm control strategy is applied in atrial fibrillation patients but adverse events such as major bleeding exist. This study aims to examine the prognostic inpact of the duration of anticoagulation after radiofrequency ablation of paroxismal atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score undergoing radiofrequency ablation is randomized into one month anticoagulation group and two months anticoagulation group after the procedure. Thromboembolic event and adverse event including major or minor bleeding would be compared.
Detailed Description
Catheter based radiofrequency ablation has been used in more than a decade as a rhythm control therapy. Recently, superior outcome to medical therapy has been constantly reported and the radiofrequency catheter ablation (RFCA) became popular globally. It is recommended to anticoagulate patients who received RFCA for atrial fibrillation at least two months after the procedure. However, a few reports suggest anticoagulation in selective patients according to CHADS2-Vasc score. Anticoagulants prevent thromboembolic event in atrial fibrillation but the risk of bleeding is increased in company. There is controversy in the duration of anticoagulation after RFCA of atrial fibrillation. The investigators aimed to investigate the association with thromboembolic and bleeding event of anticoagulation duration after RFCA of atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score who are undergoing RFCA are included and randomized by 1:1 ratio to one month anticoagulation group and two months anticoagulation group after RFCA. Any patient with an evidence of intracardiac thrombus is excluded. The primary endpoint is thromboembolic event in 6 months after RFCA and the secondary endpoint is bleeding event in 6 months after RFCA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1-month anticoagulation group
Arm Type
Experimental
Arm Description
Anticoagulation using warfarin or non-VKA oral anticoagulant for 1 month after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation.
Arm Title
2-month anticoagulation group
Arm Type
Active Comparator
Arm Description
Anticoagulation using warfarin or non-VKA oral anticoagulant for 2 months after radiofrequency catheter ablation of paroxismal atrial fibrillation and then stop anticoagulation
Intervention Type
Drug
Intervention Name(s)
Oral anticoagulant
Intervention Description
1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation
Primary Outcome Measure Information:
Title
Thromboembolic event
Description
Composite of ischemic stroke, transient ischemic attack, or other systemic embolic events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Major bleeding
Description
bleeding events that result in a reduction in hemoglobin level of at least 20 g per liter, transfusion of at least 2 units of blood, or symptomatic bleeding in a critical area or organ
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1
Exclusion Criteria:
Presence of intracardiac thrombus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-Seog Oh, MD,PhD
Phone
82-2-2258-6035
Email
oys@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ju Youn Kim, MD
Phone
82-10-5482-7307
Email
zzoo921@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Seog Oh, MD,PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
State/Province
Seo Ch-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju Youn Kim, MD
Phone
82-10-5482-7307
Email
zzoo921@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Anticoagulation After RFCA
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