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A Pilot Study on Edoxaban for the Resolution of Left Atrial Thrombosis in Patients With Non-valvular Atrial Fibrillation

NCT03489395 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-05-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Edoxaban

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.

Sponsors & Collaborators

  • Hippocrates Research

    collaborator OTHER

  • Raffaele De Caterina

    lead OTHER

Principal Investigators

  • Raffaele De Caterina · Università degli Studi G. d'Annunzio Chieti

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489395 on ClinicalTrials.gov