Edoxaban Treatment Versus VKA in patients with AF undergoing TAVI Procedure in Atrial Fibrillation.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1400

Inclusion Criteria

Subjects must satisfy all of the following criteria to be included in the
study:
1. Successful TAVI via transvascular access routes such as the femoral,
carotid, axillary, and subclavian arteries. Other access routes need prior
approval per a 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 mmHg
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
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1120

Exclusion Criteria

1. Conditions with a high risk of bleeding
o 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 contraindication to EITHER Edoxaban OR VKA per local label; this
includes hypersensitivity to the active ingredient or to any of the
excipients, or any 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 (i.e., non-approved) drugs 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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