NCT03840291CompletedPhase 4
Resolution of Thrombi in Left Atrial Appendage With Edoxaban
Source: ClinicalTrials.gov · Last updated 19 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 11 Feb 2019
- Start date
- 19 May 2019
- Primary completion date
- 30 Oct 2023
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Diseases
- Atrial fibrillation
- NCT number
- NCT03840291
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 36
- From 19 May 2019 to the primary completion date, 30 Oct 2023
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Catholic university of Korea Incheon St. Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Cardiovascular Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Catholic University of Korea Yeouido St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.