

Edoxaban Versus Standard of Care and their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation – In Atrial Fibrillation
Physician
Dr. Luis Tejada
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Synopsis: The optimal antithrombotic (‘blood thinning’) therapy in patients with atrial fibrillation following Transcatheter Aortic Valve Implantation (a catheter based procedure where a new valve is placed in the location of your old and narrowed aortic valve) is unknown at this time. This research study will compare the relative effects of two therapies.
There are two main types of blood thinners- anticoagulants and antiplatelet drugs. Anticoagulants, such as edoxaban or vitamin-K antagonists (VKA) such as warfarin, and antiplatelet drugs, such as Acetyl Salicylic Acid (ASA) (e.g. aspirin) and the drugs called P2Y12 inhibitors (e.g., clopidogrel), which prevent platelets from clumping together to form a clot.
Anticoagulants are typically used in patients with atrial fibrillation, while a combination of antiplatelets such as aspirin and a P2Y12 inhibitor is used in patients following coronary artery stenting.
Edoxaban has been developed as an alternative to VKA and has already been approved for clinical use in European countries, the United States, Japan, Hong Kong, South Korea and Taiwan for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, high blood pressure, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). It has been demonstrated that edoxaban is safer than VKA in its approved use.
In this study, edoxaban alone or in combination with aspirin and/or a P2Y12 inhibitor will be compared to a VKA alone or in combination with aspirin and/or a P2Y12 inhibitor. The treatments will be compared for safety with regard to bleeding and effectiveness with regard to thrombotic complications like stroke in patients who have atrial fibrillation AND have undergone a successful Transcatheter Aortic Valve Implantation (TAVI).
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Bleeding risks or systemic conditions
Procedure related
Medication related
Concomitant conditions and therapies
Other exclusion criteria
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