REFLEX: Resolution of Thrombi in Left Atrial Appendage With Edoxaban
Study Details
Study Description
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 (> 90%). Anticoagulation with a vitamin-K antagonist (VKA) is recommended to prevent thromboembolic complications and to resolve thrombi. Non-VKA oral anticoagulants (NOACs) have replaced the VKA for the thromboprophylaxis in patients with NVAF since 2010. Therefore, NOAC can be the excellent alternative to VKA concerning resolving preexisting LAA thrombi because of its rapid onset of action and no need of bridging with heparin. However, there is still lack of data regarding the optimal treatment for patients with AF and thrombi in LAA with NOAC. There are only several case reports of the efficacy of NOACs in resolving LAA thrombi available.
Edoxaban, which has data showing efficacy and safety in thromboprophylaxis, can be the new option for treatment of patients with AF and LAA thrombi. The purpose of this study is to evaluate the efficacy of Edoxaban in resolving the LAA thrombi, which is related with nonvalvular AF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Edoxaban
Edoxaban will be used for resolution of left atrial appendage thrombi
Other Names:
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Outcome Measures
Primary Outcome Measures
- complete resolution of LAA thrombi [6 weeks]
The percentage of subjects with complete resolution of LAA thrombi
Secondary Outcome Measures
- Treatment responses of thrombi [6 weeks]
Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi
- Ischemic stroke event [12 weeks]
The percentage of subjects who experienced ischemic stroke
- Bleeding event [12 weeks]
The percentage of subjects who experienced bleeding event
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 41931 | |
| 2 | Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 3 | Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital | Daegu | Korea, Republic of | 42415 | |
| 4 | Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center | Daegu | Korea, Republic of | 42472 | |
| 5 | Catholic University of Korea, Incheon St. Mary's hospital | Incheon | Korea, Republic of | 21431 | |
| 6 | Pusan National University Hospital | Pusan | Korea, Republic of | 49241 | |
| 7 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
| 8 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 9 | Severance Cardiovascular Hospital | Seoul | Korea, Republic of | 03722 | |
| 10 | Seoul Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 11 | Catholic University of Korea Yeouido St. Mary's Hospital | Seoul | Korea, Republic of | 07345 | |
| 12 | Wonju Severance Christian Hospital | Wŏnju | Korea, Republic of | 26426 |
Sponsors and Collaborators
- Keimyung University Dongsan Medical Center
- Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
Investigators
- Study Chair: Seongwook Han, M.D., Ph.D., Keimyung University Dongsan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-09-041