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Completed

NCT Number: NCT03840291

Resolution of Thrombi in Left Atrial Appendage With Edoxaban

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Left Atrial Appendage Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edoxaban

Drug

Edoxaban will be used for resolution of left atrial appendage thrombi

Other names: Lixiana®

Primary outcomes

  1. complete resolution of LAA thrombi

    Time frame: 6 weeks

    The percentage of subjects with complete resolution of LAA thrombi

Secondary outcomes

  1. Treatment responses of thrombi

    Time frame: 6 weeks

    Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi

  2. Ischemic stroke event

    Time frame: 12 weeks

    The percentage of subjects who experienced ischemic stroke

  3. Bleeding event

    Time frame: 12 weeks

    The percentage of subjects who experienced bleeding event

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Collaborators

  • Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company

Registry information

Acronym: REFLEX

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Feb 15, 2019
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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