arrythmia in patients that had a transplantation of a aortic valve
Conditions
Interventions
* Edoxaban-based regimen:
Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects
(dose reduction criteria according to locally approved label).
* VKA-based regimen:
The VKA of choice
Atrial Fibrillation
Edoxaban
Transcatheter Aortic Valve Implantation
Sponsors
Daiichi Pharmaceutical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 30 seconds documented by ECG), 3. Provision of signed informed consent, 4. Age *18 years
Exclusion criteria
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 Exclusion criteria: Refer to Protocol, section: 4.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: * NACE defined as the composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major and minor bleeding per TIMI definitions * NACE defined as the composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding (Bleeding Academic Research Consortium [BARC] 3 or 5 definition) * NACE defined as the composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major and moderate bleeding (Global Utilization of Streptokinase And Tissue Plasminogen Activator For Occluded Coronary arteries [GUSTO] definition) * Major Adverse Cardiac Events (MACE), defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, or repeat coronary revascularization of the target lesion * Major Adverse Cardiac and Cerebrovascular Events (MACCE), defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, stroke (ischemic, hemorrhagic, or undetermined), or repeat coronary revascularization of the target lesion * Cardiovascular mortality * Stroke (ischemic, hemorrhagic, or undetermined) * Stroke (ischemic) * Stroke (hemorrhagic) * Stroke (undetermined) * Fatal stroke (ischemic, hemorrhagic, or undetermined) * Non-fatal stroke (ischemic, hemorrhagic, or undetermined) * SEE * Myocardial Infarction * Valve thrombosis Safety endpoints: * Bleeding defined as TIMI major and minor, BARC 3 or 5, and GUSTO moderate or severe * Bleeding defined as ISTH major and CTNM, TIMI major/minor bleeds or requiring medical attention, BARC 2, 3 or 5, and GUSTO moderate or severe * Bleeding defined as ISTH, CRNM, TIMI minor or requiring medical attention, BARC 2, and GUSTO moderate * All bleeding that are not ISTH major, CRNM, TIMI minimal, BARC 1 non-actionable, and GUSTO mild * Any bleeding * Intracranial hemorrhage * Life-threatening bleeding * Fatal bleeding (fulfilling the ISTH major bleeding definition) * Non-fatal major bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| * Number of hospital admissions, defined as * 24 h stay in the hospital, due to cardiovascular causes (post TAVI and non-TAVI procedure related), including but not limited to overall, for bleeding, SEE, venous thrombosis, shock, arrhythmia, cardiac rupture, stroke, aneurysms, stent occlusions, etc.) o Note: Hospital admissions due to cardiovascular causes include, but are not limited to Emergency Department (ED), Intensive Care Unit (ICU), cardiovascular ward * Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q) * Health related quality of life as assessed by the EuroQoL (EQ-5D-5L) Questionnaire * Biomarker of hemostasis such as but not limited to markers of coagulation and aggregation (sub-study) such as whole blood clotting time (WBCT), thrombelasto-graphy (TEG), multiple electrode aggregometry (MEA) | — |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States of America
Outcome results
None listed