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Atrial FibrillationPhase 2NCT03489395

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

A Phase 2 study testing Edoxaban in people with Atrial Fibrillation, run by Raffaele De Caterina at 8 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Edoxaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
8 sitesItaly
Study dates
30 Jan 2018to 30 Apr 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with all the following criteria will be eligible for inclusion in the study protocol:
  • 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:
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  • -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.

Who cannot join

  • Patients with all the following criteria will not be eligible for inclusion in the study protocol:
  • 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.
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  • 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.
  • Sustained uncontrolled hypertension: Systolic Blood Pressure ≥180 mmHg or Diastolic Blood Pressure ≥100 mmHg.
  • Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive within 3 months or any stroke < 14 days).
  • Transient ischemic attack within 3 days.
  • Any oral anticoagulant therapy at the time of the baseline visit.
  • Treatment with:
  • aspirin >160 mg daily;
  • aspirin plus a thienopyridine within 5 days;
  • intravenous antiplatelets within 5 days;
  • fibrinolytics within 10 days.
  • Anticipated need for therapy with a non-steroidal anti-inflammatory drug in the next 4 weeks.
  • Treatment with a strong inducer of cytochrome P450 and P glycoprotein, such as ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, lopinavir, telaprevir, indinavir, conivaptan, clarithromycin or planned treatment during the study.
  • Other indication for anticoagulant therapy.
  • Hypersensitivity or intolerance to the study drug, including excipients.
  • Women of childbearing potential who do not want adopt a contraceptive method during the study period and the following 4 weeks.
  • Breast-feeding women during the study period and the following 4 weeks.
  • Anemia (hemoglobin <10 g/dL) at the screening visit.
  • Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine aminotransferase or Aspartate aminotransferase >2 x Upper Level of Normal or total bilirubin >1.5 x Upper Level of Normal.
  • Patients with moderate or severe renal impairment (CrCL <50 mL/min) or patients with end stage renal disease (CrCL < 15 mL/min) or on dialysis.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • Ospedale generale regionale "F. Miulli"

    Acquaviva delle Fonti, Bari, 70021

  • AORN S.ANNA e S.SEBASTIANO

    Caserta, 81100

  • Università degli Studi G. D'Annunzio

    Chieti, 66013

  • Ospedale P. Monaldi

    Naples, 80131

  • Policlinico AO di Padova

    Padova, 35128

  • Presidio Ospedaliero S. Maria delle Grazie

    Pozzuoli, Napoli, 80078

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • Ospedale Madonna del Soccorso

    San Benedetto del Tronto, Ascoli Piceno, 63074

Other trials in Italy

About this study

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.

Read the detailed description

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.

Being tested
Edoxaban
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

    Also called Lixiana

    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.

Study groups in NCT03489395
Study groupRoleWhat they receive
EdoxabanExperimentalUsed 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.
Receives: Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (3)

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

    Only a descriptive statistical analysis will be performed.

    Measured: 4 weeks

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

    Only a descriptive statistical analysis will be performed.

    Measured: 4 weeks

  3. Time to electrical cardioversion (when applicable).

    Only a descriptive statistical analysis will be performed.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start30 Jan 2018
  3. Primary completion31 Dec 2020
  4. Study completion30 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Non-controlled, open-label pilot study.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03489395
Sponsor's protocol ID
EDO-SP-01-2015
Other IDs
2015-004847-37, 2015
Status last verified
May 2021
First submitted
15 Mar 2018
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Edoxaban in people with Atrial Fibrillation, run by Raffaele De Caterina at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with complete thrombus resolution by TEE, evaluated with the following Probe angulations: 0°, 45°-to-60°, 90°. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03489395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.

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