Resolution of Thrombi in Left Atrial Appendage With Edoxaban

Phase 4

Completed

• Conditions: Atrial Fibrillation; Left Atrial Appendage Thrombosis
• Interventions: Drug: Edoxaban

• Registration Number: NCT03840291
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Study Start: 2019-05-19
• Primary Completion: 2023-10-30
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Edoxaban treatment	Edoxaban	1. 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. 2. Patients in this group are taking Lixiana® (Edoxaban) 60mg for resolution of left atrial appendage thrombi 3. 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.

Primary Outcome Measures

Name	Time	Method
complete resolution of LAA thrombi	6 weeks	The percentage of subjects with complete resolution of LAA thrombi

Secondary Outcome Measures

Name	Time	Method
Bleeding event	12 weeks	The percentage of subjects who experienced bleeding event
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

Trial Locations

Locations (12)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Catholic University of Korea, Incheon St. Mary's hospital; 🇰🇷 Incheon, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Catholic University of Korea Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Cardiovascular Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Korea, Republic of

Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of

Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of