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

Phase 1

• Conditions: Patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation after transcatheter aortic valve implantation (TAVI); MedDRA version: 19.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003930-26-ES
• Lead Sponsor: Daiichi Sankyo Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-10
• Study Completion: 2021-02-28
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1426

Inclusion Criteria

Subjects must satisfy all of the following criteria to be included in the study:
1. Successful transfemoral TAVI with any approved/marketed device (other access routes may only be used if they become standard of care with a proven superior outcome and after written approval of this study’s Executive Committee); 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 overt stroke
d. No uncontrolled bleeding at time of randomization
2. Indication for chronic OAC
a. Pre-existing atrial fibrillation (AF)
b. New onset AF (> 30 seconds documented by ECG recording)
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. History of life-threatening or major bleeding event = BARC 3b definitions within the last year
2. Other conditions with a high risk of bleeding
o This may include but is not limited to: active peptic ulcer or upper gastrointestinal (GI) bleeding within last 3 months prior to randomization, malignancy at high risk of bleeding, recent unresolved brain or spinal injury, spinal or ophthalmic surgery (within the last 3 months prior to randomization), any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities.
3. Other known bleeding diatheses
4. Serious unresolved periprocedural complications
5. Hypersensitivity or contraindications to Edoxaban, VKA, ASA, and/or P2Y12 antagonists
6. Concomitant treatment with other antithrombotic agents, ASA > 100 mg/day, fibrinolytic therapy, or chronic (> 4 days/week) use of nonsteroidal antiinflammatory drugs (NSAIDs)
7. Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to randomization
8. Treatment with other investigational 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