Edoxaban treatment versus anticoagulant treatment (here Vitamin K antagonist) in patients with atrial fibrilation undergoing a catheter ablatio

Phase 1

• Conditions: Subjects undergoing catheter ablation of non-valvularatrial fibrillation; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003069-25-HU
• Lead Sponsor: Daiichi Sankyo Europe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-20
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1.Male or female at least 18 years of age with documented history of paroxysmal (lasting =7 days), persistent (lasting >7 days but =12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject’s medical records (e.g., medical chart, hospital discharge summary).
2.Subject is eligible and is scheduled for either radiofrequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
3.Signed ICF.

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 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1.AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis,
pneumonia, severe anemia etc.)
2.Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization
3.Subject has a thrombus in the left atrial appendage, left atrium, left ventricle, or aorta, or an intracardial mass
4.Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft surgery within 3 months prior to the randomization
5.Subject has signs of bleeding,history of clinically-relevant bleeding according to ISTH,or conditions associated with high risk of bleeding such as past history of intracranial ,or spontaneous intraocular, spinal, retroperitoneal, or intra-articular bleeding; overt gastrointestinal bleeding or active ulcer within the previous year; recent severe trauma, major surgery, or deep organ biopsy; active infective endocarditis; uncontrolled hypertension (blood pressure [BP] above 170/100 mmHg);or hemorrhagic disorder including known or suspected hereditary or acquired bleeding or coagulation disorder in the last 12 months prior to randomization
6.Subjects with mechanical heart valves, subjects with moderate to severe mitral stenosis and subjects who have new implantation of a bioprosthetic heart valve, with or without AF
7.Subjects with a history of LAA occlusion/exclusion
8.Subjects with any contraindication for edoxaban, VKA,low molecular weight heparin,heparin therapy,including known allergies, hypersensitivity, or intolerance to any component of these drugs or its excipients
9.Subjects receiving dual antiplatelet therapy (DAPT, i.e., aspirin and P2Y12 antagonist) or planned to receive DAPT during the study
10.Unfractionated heparin,low molecular weight heparins, heparin derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban etc.)should not be used concomitantly to study medication.Any bridging with LMWH around the CA procedure is prohibited.During the CA procedure,UFH will be used according to standard of care to achieve ACT of 300 to 400 sec.Subjects who require chronic use of medicines affecting hemostasis such as higher doses of aspirin(ASA up to 100 mg per day allowed) or chronic oral or parenteral intake of non-aspirin non-steroidal anti inflammatory
drugs (NSAID) on =4 days/week
11.Subjects with active liver disease or persistent elevation of liver
enzymes/bilirubin:
?Alanine transaminase or aspartate transaminase =2 times the upper limit of normal
?Total bilirubin (TBL) =1.5 times the ULN (subjects whose elevated TBL is due to known Gilbert's syndrome may be included in the study)
?Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
12.Subjects with kidney failure (creatinine clearance<15 mL/min)
13.Subjects with hemoglobin <10 g/dL or platelet count <100,000
cells/µL or white blood cell count <3000 cells/µL
14.Subjects with pre-planned invasive diagnostic or therapeutic
procedures/interventions (other than endoscopy) during the study period in which bleeding is anticipated
15.Participation in any other interventional trial (subjects who received any investigational drug or device within 30 days prior to
randomization,or plan to receive such therapy during the study period)
16.Previous randomization in this study
17.Female subjects of childbearing potential without using highly
effective cont

Study & Design

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