Study Stopped
Majority of enrolled patients have withdrawn.
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation
ATEMS-AF
1 other identifier
interventional
48
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 atrial-fibrillation
Started Feb 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedStudy Start
First participant enrolled
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedSeptember 9, 2020
September 1, 2020
2.8 years
February 2, 2017
September 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
2 year
Study Arms (3)
Antiplatelet therapy
EXPERIMENTALacetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA
Low-dose OAC therapy
EXPERIMENTALEdoxaban of 30mg (Reduced dose of 15mg if body weight \< 60kg, CCr\< 50 ml/min, concomittant use of P-gp)
Standard-dose OAC therapy
ACTIVE COMPARATOREdoxaban of 60mg (Reduced dose of 30mg if body weight \< 60kg, CCr\< 50 ml/min, concomittant use of P-gp)
Interventions
ASA or clopidogrel
Edoxaban of 60mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Euy Lim, Dr.
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 2, 2017
First Posted
March 8, 2017
Study Start
February 23, 2017
Primary Completion
December 15, 2019
Study Completion
December 15, 2019
Last Updated
September 9, 2020
Record last verified: 2020-09