Resolution of Thrombi in Left Atrial Appendage With Edoxaban

NCT03840291 | Completed Phase 4 DMC

• 1 other identifier: 2018-09-041
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• complete resolution of LAA thrombi

  The percentage of subjects with complete resolution of LAA thrombi

  6 weeks

Secondary Outcomes (3)

• Treatment responses of thrombi

  6 weeks

• Ischemic stroke event

  12 weeks

• Bleeding event

  12 weeks

Study Arms (1)

Edoxaban treatment

EXPERIMENTAL

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.

Drug: Edoxaban

Interventions

Edoxaban DRUG

Edoxaban will be used for resolution of left atrial appendage thrombi

Also known as: Lixiana®

Edoxaban treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company: collaborator

Study Sites (12)

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

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

Daegu, 41944, South Korea

Location

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

Daegu, 42415, South Korea

Location

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

Daegu, 42472, South Korea

Location

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

Incheon, 21431, South Korea

Location

Pusan National University Hospital

Pusan, 49241, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Cardiovascular Hospital

Seoul, 03722, South Korea

Location

Seoul Samsung Medical Center

Seoul, 06351, South Korea

Location

Catholic University of Korea Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seongwook Han, M.D., Ph.D.

  Keimyung University Dongsan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: May 19, 2019
• Primary Completion: October 30, 2023
• Study Completion: August 1, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

KR (12)