Status:
COMPLETED
Resolution of Thrombi in Left Atrial Appendage With Edoxaban
Lead Sponsor:
Keimyung University Dongsan Medical Center
Collaborating Sponsors:
Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
Conditions:
Atrial Fibrillation
Left Atrial Appendage Thrombosis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Non-valvular (NV) atrial fibrillation (AF) increases the risk of stroke by approximately fivefold. The atrial thrombi associated with AF are seen within the left atrial appendage (LAA) in most cases (...
Eligibility Criteria
Inclusion
- Men or women aged ≥ 20 years
- Hemodynamically stable nonvalvular AF or atrial flutter
- LAA thrombus documented by TEE up to 72 hours prior to start of study medication
- VKA or NOAC-naïve or untreated within 1 month prior to sign the informed consent
- VKA pretreated but under the therapeutic International Normalized ratio levels (\<2.0; documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
- Women of childbearing potential and men must agree to use adequate contraception when sexually active
Exclusion
- Transient Ischemic Attack within 3 days prior to study inclusion
- Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
- Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
- Acute myocardial infarction within the last 14 days prior to study inclusion
- Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Key Trial Info
Start Date :
May 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03840291
Start Date
May 19 2019
End Date
August 1 2024
Last Update
August 19 2024
Active Locations (12)
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1
Keimyung University Dongsan Medical Center
Daegu, South Korea, 41931
2
Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
Daegu, South Korea, 41944
3
Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
Daegu, South Korea, 42415
4
Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center
Daegu, South Korea, 42472