Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation ¿ In Atrial Fibrillation. ENVISAGE TAVI-AF - ENVISAGE - TAVIAF

DAIICHI SANKYO INC.0 个研究点目标入组 1,426 人开始时间: 2021年6月8日最近更新: 2022年4月4日

适应症

试验速览

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•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 clinically 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 (e.g.> 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

•1. 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 90 days prior to randomization, malignancy at high risk of bleeding, recent unresolved brain or spinal injury, spinal or ophthalmic surgery (within the last 90 days prior to randomization), any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities.
•2. Other known bleeding diatheses
•3. Conditions that make it difficult for the subject to take the study medication
•4. Serious unresolved periprocedural complications
•5. Any contraindications to BOTH Edoxaban AND VKA per local label, 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) at randomization that will be indicated for more than 4 weeks beyond 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

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