Effect of edoxaban on left atrial thrombosis
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003599
- Lead Sponsor
- Keimyung University Dongsan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
•Men or women aged = 19 years, <80 years
•Hemodynamically stable nonvalvular AF or atrial flutter
•VKA or NOAC-naïve or untreated within 1 month prior to sign the informed consent
•LAA thrombus documented by TEE up to 72 hours prior to start of study medication
•A person who understands the written description of the research method and has completed the written consent form
•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
i. Current history or history of hemorrhage or coagulation disorders
ii. Thrombocytopenia
iii. Pregnant patient
•Patients who can not follow up after medication
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of subjects with complete resolution of LAA thrombi
- Secondary Outcome Measures
Name Time Method Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi;The percentage of subjects who experienced ischemic stroke;The percentage of subjects who experienced bleeding event