Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (ATEMS-AF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Antiplatelet
Low dose oral anticoagulant
Standard dose oral anticoagulant
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.
- Willing and able to provide informed consent
Exclusion Criteria:
- Patients who do not meet all of the above listed inclusion criteria.
- Patients with significant valvular heart disease or mechanical valve.
- Patients with hypertrophic cardiomyopathy.
- Patients with chronic renal impairment with creatinine clearance rate of < 30 mg/dl.
- Patients with contraindication to long-term OAC.
- Patients who had a stroke within one year prior to enrolment.
Sites / Locations
- Korea University Anam Hospital
- Korea University Guro Hospital
- Seoul National University Hospital
- Yonsei University Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Antiplatelet therapy
Low-dose OAC therapy
Standard-dose OAC therapy
Arm Description
acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA
Edoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)
Edoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)
Outcomes
Primary Outcome Measures
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure
Check stroke or systemic embolism through neurologic examination or imaging studies
Secondary Outcome Measures
Full Information
NCT ID
NCT03073850
First Posted
February 2, 2017
Last Updated
September 5, 2020
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03073850
Brief Title
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation
Acronym
ATEMS-AF
Official Title
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Majority of enrolled patients have withdrawn.
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).
Detailed Description
The investigators hypothesize that the strategy of OAC will be superior to antiplatelet therapy, but low dose edoxaban (30mg) will be non-inferior to standard dose edoxaban (60mg) for reducing the risk of stroke or systemic embolism in patients who underwent successful AF ablation. Although AF ablation is an effective therapy for reducing and/or eliminating the burden of AF, there may continue to be a risk of late recurrence or asymptomatic recurrence of atrial tachyarrhythmias. Until now, the guideline has recommended the continuation of OAC in patients who are at risk of stroke or systemic embolism based on the CHA2DS2-VASc score, even though they have maintained sinus rhythm. The annual rate of stroke, however, is still lower compared to that predicted by the scoring system, because AF ablation reduced the AF burden by 86% and the remaining episodes were significantly shorter in duration (median 6 minutes) than those pre-ablation reported by the previous study. Based on recent studies which demonstrated that both standard-dose and low-dose non-vitamin K OACs (NOAC) performed equally well with regard to the stroke prevention in patients with AF, low dose NOACs may also be sufficient for stroke prevention of briefly lasting AF episodes after successful AF ablation.
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
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antiplatelet therapy
Arm Type
Experimental
Arm Description
acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA
Arm Title
Low-dose OAC therapy
Arm Type
Experimental
Arm Description
Edoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)
Arm Title
Standard-dose OAC therapy
Arm Type
Active Comparator
Arm Description
Edoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)
Intervention Type
Drug
Intervention Name(s)
Antiplatelet
Other Intervention Name(s)
aspirin 100mg or clopidogrel 75mg
Intervention Description
ASA or clopidogrel
Intervention Type
Drug
Intervention Name(s)
Low dose oral anticoagulant
Other Intervention Name(s)
Edoxaban of 30mg
Intervention Description
Edoxaban of 30mg
Intervention Type
Drug
Intervention Name(s)
Standard dose oral anticoagulant
Other Intervention Name(s)
Edoxaban of 60mg
Intervention Description
Edoxaban of 60mg
Primary Outcome Measure Information:
Title
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure
Description
Check stroke or systemic embolism through neurologic examination or imaging studies
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.
Willing and able to provide informed consent
Exclusion Criteria:
Patients who do not meet all of the above listed inclusion criteria.
Patients with significant valvular heart disease or mechanical valve.
Patients with hypertrophic cardiomyopathy.
Patients with chronic renal impairment with creatinine clearance rate of < 30 mg/dl.
Patients with contraindication to long-term OAC.
Patients who had a stroke within one year prior to enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Euy Lim, Dr.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation
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