A pilot study on Edoxaban for the resolution of left atrial thrombosis in patients with non-valvular atrial fibrillatio

Phase 1

• Conditions: on-Valvular Atrial Fibrillation; MedDRA version: 20.0Level: LLTClassification code 10016566Term: Fibrillation atrialSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-004847-37-IT
• Lead Sponsor: FONDAZIONE G. D'ANNUNZIO, CHIETI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Patients with all the following criteria will be eligible for inclusion in the study protocol:
1.Signed written informed consent.
2.Males and females = 18 years of age.
3.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 ß-hCG pregnancy test at screening.
4.Atrial fibrillation (AF) must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolment.
5.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.
6.LA or LAA thrombosis documented by trans-esophageal echocardiography (TEE)
7.CHA2DS2-VASC score >1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Patients with all the following criteria will not be eligible for inclusion in the study protocol:
1.Hemodynamically significant mitral valve stenosis.
2.Prosthetic heart mechanical or biological valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted).
3.Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery or myocardial infarction).
4.Known presence of atrial myxoma.
5.Left ventricular thrombus.
6.Active endocarditis.
7.Active internal bleeding.
8.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.
9.Platelet count <90,000/µL at the screening visit.
10.Sustained uncontrolled hypertension: SBP =180 mmHg or DBP =100 mmHg.
11.Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive within 3 months or any stroke < 14 days).
12.Transient ischemic attack within 3 days.
13.Treatment with:
•Any NAO or VKA with optimal INR (optimal = all INR values =2.0 in the previous 30 days)
•aspirin >160 mg daily;
•aspirin plus a thienopyridine within 5 days;
•intravenous antiplatelets within 5 days;
•fibrinolytics within 10 days.
14.Anticipated need for therapy with a non-steroidal anti-inflammatory drug in the next 4 weeks.
15.Treatment with a strong inducer of cytochrome P450 and P glycoprotein, such as ritonavir, lopinavir, telaprevir, indinavir or planned treatment during the study.
16.Other indication for anticoagulant therapy.
17.Hypersensitivity or intolerance to the study drug, including excipients.
18.Women of childbearing potential who do not want adopt a contraceptive method during the study period and the following 4 weeks.
19.Breast-feeding women during the study period and the following 4 weeks.
20.Anemia (hemoglobin <10 g/dL) at the screening visit.
21.Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT or AST >2 x ULN or total bilirubin >1.5 x ULN.
22.Patients with severe renal impairment (CrCL <30 mL/min) or on dialysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified