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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03840291
Other study ID # 2018-09-041
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 19, 2019
Est. completion date August 2024

Study information

Verified date May 2023
Source Keimyung University Dongsan Medical Center
Contact Jongmin Hwang, M.D., Ph.D.
Phone +82-53-250-7333
Email dsmcep@dsmc.or.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2024
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Intervention

Drug:
Edoxaban
Edoxaban will be used for resolution of left atrial appendage thrombi

Locations

Country Name City State
Korea, Republic of Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center 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, Yeungnam University Hospital Daegu
Korea, Republic of 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 Catholic University of Korea Yeouido St. Mary's Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul Samsung Medical Center Seoul
Korea, Republic of Severance Cardiovascular Hospital Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju

Sponsors (2)

Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary complete resolution of LAA thrombi The percentage of subjects with complete resolution of LAA thrombi 6 weeks
Secondary Treatment responses of thrombi Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi 6 weeks
Secondary Ischemic stroke event The percentage of subjects who experienced ischemic stroke 12 weeks
Secondary Bleeding event The percentage of subjects who experienced bleeding event 12 weeks
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