Resolution of Thrombi in Left Atrial Appendage With Edoxaban

  • STATUS
    Recruiting
  • End date
    Aug 25, 2023
  • participants needed
    60
  • sponsor
    Keimyung University Dongsan Medical Center
Updated on 25 January 2021
heparin
stroke
anticoagulants
fibrillation
noac
edoxaban
atrial flutter
anticoagulation therapy

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.

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Atrial Fibrillation (Pediatric), Dysrhythmia, Left Atrial Appendage Thrombosis
Treatment Edoxaban
Clinical Study IdentifierNCT03840291
SponsorKeimyung University Dongsan Medical Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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-nave 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note