Isolated reports have indicated that complete Left Atrial or Left Atrial Appendage thrombus resolution may be achieved also with use of oral Factor Xa inhibitors, which have demonstrated the same efficacy but a better safety profile compared to warfarin. The aim of this open-label pilot study is to investigate the percentage of Left Atrial /Left Atrial Appendage thrombus resolution with edoxaban therapy in patients with non-valvular atrial fibrillation. The subordinated aim is the design a larger and longer study to compare edoxaban and warfarin in the same patient population. With the exception of few case reports, there are no data in the same patient population referred to antithrombotic treatments other than vitamin K antagonists.
This is a non-controlled, open-label, 4 weeks pilot study. As the main goal of this exploratory study is the estimation of the magnitude of the Left Atrial /Left Atrial Appendage thrombus resolution with edoxaban, no control group with vitamin K antagonists has been considered, providing that, for the purpose of this study, the magnitude of the response of warfarin is satisfactory defined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Edoxaban 60 mg once a day for 4 weeks. Edoxaban 30 mg/day in patients with body weight ≤60 kg, or with concomitant therapy with verapamil/quinidine/dronedarone.
Ospedale Madonna del Soccorso
San Benedetto del Tronto, Ascoli Piceno, Italy
Ospedale generale regionale "F. Miulli"
Acquaviva delle Fonti, Bari, Italy
Presidio Ospedaliero S. Maria delle Grazie
Pozzuoli, Napoli, Italy
AORN S.ANNA e S.SEBASTIANO
Caserta, Italy
Università degli Studi G. D'Annunzio
Chieti, Italy
Ospedale P. Monaldi
Napoli, Italy
Policlinico AO di Padova
Padua, Italy
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Percentage of patients with complete thrombus resolution by TEE, evaluated with the following Probe angulations: 0°, 45°-to-60°, 90°.
Only a descriptive statistical analysis will be performed.
Time frame: 4 weeks
Absolute variation of thrombus area by TEE evaluation (Probe angulations: 0°, 45-to-60°, 90°)
Only a descriptive statistical analysis will be performed.
Time frame: 4 weeks
Percent variation of thrombus area by TEE evaluation (Probe angulations: 0°, 45-to-60°, 90°)
Only a descriptive statistical analysis will be performed.
Time frame: 4 weeks
Time to electrical cardioversion (when applicable).
Only a descriptive statistical analysis will be performed.
Time frame: 4 weeks
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