Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation * In Atrial Fibrillation.

Phase 3

Completed

• Conditions: 10007521; arrythmia in patients that had a transplantation of a aortic valve

• Registration Number: NL-OMON50179
• Lead Sponsor: Daiichi Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Subjects must satisfy all of the following criteria to be included in the
study:, 1. Successful TAVI via transvascular access route such as to the
femoral, carotid, axillary, and subclavian arteries. Other access routes need
prior approval per majority vote from 3 members of the Executive Committee
(both Global Lead Investigators and the Daiichi Sankyo Medical Lead or his/her
designee); success is defined as:, a. Correct positioning of a single
prosthetic heart valve into the proper anatomical location
b. Presence of all 3 conditions post TAVI
i. Mean aortic valve gradient <20 mm Hg
ii. Peak transvalvular velocity <3.0 m/s
iii. Aortic valve regurgitation of 2 or less
c. No clinically overt stroke
d. No uncontrolled bleeding at time of randomization, 2. Indication for chronic
OAC
a. Documented pre-existing AF
b. New onset AF (e.g. >30 seconds documented by ECG), 3. Provision of signed
informed consent, 4. Age *18 years

Exclusion Criteria

1. Conditions with a high risk of bleeding
This may include but is not limited to: active peptic ulcer with upper
gastrointestinal bleeding within last 90 days prior to randomization,
malignancy at high risk of bleeding, major intraspinal or intracerebral
vascular abnormalities, recent unresolved brain or spinal injury, or spinal
surgery (recent = within the last 90 days prior to randomization), any
intracranial hemorrhage, known or suspected esophageal varices, arteriovenous
malformations, or clinically relevant vascular aneurysms., 2. Other known
bleeding diatheses, 3. Conditions that make it difficult for the subject to
swallow the study medication , 4. Serious unresolved periprocedural
complications, 5. Any contraindications to EITHER Edoxaban OR VKA, per local
label; this includes hypersensitivity to the active ingredient, to any of the
excipients, or any of the components of the study medications, 6. Concomitant
treatment with other antithrombotic agents, ASA >100 mg/day, fibrinolytic
therapy, or chronic (> 4 days/week) use of nonsteroidal antiinflammatory drugs
(NSAIDs); however, NSAID patches are permitted, 7. Requirement for
dual-antiplatelet therapy (DAPT) at randomization that will be indicated for
more than 3 months beyond the first OAC dose., 8. Treatment with other
investigational drugs (i.e. non-approved) or devices within 30 days before
enrollment or planned use of investigational drugs or devices during the study,
For full list of Refer to Protocol, section: 4.2

Study & Design

• Study Type: Interventional
• Study Design: Not specified