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

NCT03489395 | Completed Phase 2

• 2 other identifiers: EDO-SP-01-20152015-004847-37
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• Absolute variation of thrombus area by TEE evaluation (Probe angulations: 0°, 45-to-60°, 90°)

  4 weeks

• Percent variation of thrombus area by TEE evaluation (Probe angulations: 0°, 45-to-60°, 90°)

  4 weeks

• Time to electrical cardioversion (when applicable).

  4 weeks

Other Outcomes (3)

• Safety analysis - Percentage of bleeding events (telephone assessment)

  4 weeks and 8 weeks

• Safety analysis - Percentage of any stroke or peripheral embolism (telephone assessment)

  4 weeks and 8 weeks

• Safety analysis - Percentage of any other safety related events (deaths, Serious Adverse Events and Adverse Events).

  4 weeks and 8 weeks

Study Arms (1)

Edoxaban

EXPERIMENTAL

Used for Treatment. All patients will receive edoxaban 60 mg once a day, with open-label design, for 4 weeks. Edoxaban daily dose will be reduced to 30 mg/day in case of: body weight ≤60 kg, or concomitant therapy with verapamil/quinidine/dronedarone.

Drug: Edoxaban

Interventions

Edoxaban DRUG

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.

Also known as: Lixiana

Edoxaban

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Males and females ≥ 18 years of age.
• Female subjects must be post-menopausal (for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum β-human chorionic gonadotropin pregnancy test at screening.
• Atrial fibrillation (AF) must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolment.
• Subjects with newly diagnosed atrial fibrillation are eligible provided that:
• there is evidence that the atrial fibrillation is non-valvular:
• there is ECG evidence on 2 occasions 24 hours apart demonstrating atrial fibrillation.
• Left Atrial or Left Atrial Appendage thrombosis documented by trans-esophageal echocardiography (TEE)
• Cardiac failure, Hypertension, Age (x2 ), Diabetes, Stroke (x 2) risk index-VASC score \>1.

You may not qualify if:

• Hemodynamically significant mitral valve stenosis.
• Prosthetic heart mechanical or biological valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted).
• Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery or myocardial infarction).
• Known presence of atrial myxoma.
• Left ventricular thrombus.
• Active endocarditis.
• Active internal bleeding.
• History of condition associated with increased bleeding risk including, but not limited to:
• major surgical procedure or trauma within 30 days;
• clinically significant gastrointestinal bleeding within 6 months;
• previous intracranial, intraocular, spinal, atraumatic intra-articular bleeding;
• chronic haemorrhagic disorder;
• Any neoplasm, including intracranial neoplasm,
• arteriovenous malformation or aneurysm.
• Platelet count \<90,000/μL at the screening visit.

Sponsors & Collaborators

• Raffaele De Caterina: lead
• Hippocrates Research: collaborator

Study Sites (8)

Ospedale Madonna del Soccorso

San Benedetto del Tronto, Ascoli Piceno, 63074, Italy

Location

Ospedale generale regionale "F. Miulli"

Acquaviva delle Fonti, Bari, 70021, Italy

Location

Presidio Ospedaliero S. Maria delle Grazie

Pozzuoli, Napoli, 80078, Italy

Location

AORN S.ANNA e S.SEBASTIANO

Caserta, 81100, Italy

Location

Università degli Studi G. D'Annunzio

Chieti, 66013, Italy

Location

Ospedale P. Monaldi

Napoli, 80131, Italy

Location

Policlinico AO di Padova

Padua, 35128, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raffaele De Caterina

  Università degli Studi G. d'Annunzio Chieti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Non-controlled, open-label pilot study.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 5, 2018
• Study Start: January 30, 2018
• Primary Completion: December 31, 2020
• Study Completion: April 30, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

IT (8)