Resolution of Thrombi in Left Atrial Appendage With Edoxaban (REFLEX)
Atrial Fibrillation, Left Atrial Appendage Thrombosis
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Keimyung University Dongsan Medical CenterRecruiting
- Division of Cardiology, Department of Internal Medicine, Kyungpook National University HospitalRecruiting
- Division of Cardiology, Department of Internal Medicine, Yeungnam University HospitalRecruiting
- Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical CenterRecruiting
- Catholic University of Korea, Incheon St. Mary's hospitalRecruiting
- Pusan National University HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance Cardiovascular HospitalRecruiting
- Seoul Samsung Medical CenterRecruiting
- Catholic University of Korea Yeouido St. Mary's HospitalRecruiting
- Wonju Severance Christian HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Edoxaban treatment
Men or women aged ≥ 20 years with NVAF patients who has LAA thrombi documented by transesophageal echocardiography (TEE) up to 72 hours prior to start of study medication are eligible. Patients in this group are taking Lixiana® (Edoxaban) 60mg for resolution of left atrial appendage thrombi Reduced (30mg) dose is administered in patients with one or more of the following clinical factors: Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min) Low body weight ≤ 60 kg Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin,dronedarone, erythromycin, or ketoconazole.