Resolution of Thrombi in Left Atrial Appendage With Edoxaban

Atrial Fibrillation Clinical Trial

— REFLEX  

Official title:

Resolution of Thrombi in Left Atrial Appendage With Edoxaban

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03840291
• Other study ID #: 2018-09-041
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage Thrombosis
• Thrombosis

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