Resolution of Thrombi in Left Atrial Appendage With Edoxaban

NCT ID: NCT03840291

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-19
• Study Completion Date: 2024-08-01

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Edoxaban treatment

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.

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

Edoxaban will be used for resolution of left atrial appendage thrombi

Interventions

Edoxaban

Edoxaban will be used for resolution of left atrial appendage thrombi

Intervention Type: DRUG

Other Intervention Names

Lixiana®

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company

INDUSTRY

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seongwook Han

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seongwook Han, M.D., Ph.D.

Role: STUDY_CHAIR

Keimyung University Dongsan Medical Center

Locations

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital

Daegu, , South Korea

Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital

Daegu, , South Korea

Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center

Daegu, , South Korea

Catholic University of Korea, Incheon St. Mary's hospital

Incheon, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Cardiovascular Hospital

Seoul, , South Korea

Seoul Samsung Medical Center

Seoul, , South Korea

Catholic University of Korea Yeouido St. Mary's Hospital

Seoul, , South Korea

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

2018-09-041

Identifier Type: -

Identifier Source: org_study_id