Surgery: Clinical Research

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Clinical Trial Details

Title
Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a Rivaroxaban-based Antithrombotic Strategy to an Antiplatelet-based Strategy After Transcatheter Aortic Valve Replacement (TAVR) to Optimize Clinical Outcomes
Study Purpose
The purposed of this study is to assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).
Study Plan
It will be decided by chance which treatment strategy will be prescribed to you. You may receive either rivaroxaban plus aspirin for the first 3 months after entering the study, followed by rivaroxaban alone until the end of study called the “rivaroxaban plus aspirin treatment strategy”; or you may receive clopidogrel plus aspirin for the first 3 months after entering the study, followed by aspirin alone until the end of study, called the “clopidogrel plus aspirin treatment strategy”.
Investigators

Principal Investigator
Daniel Soffer, M.D.
Medicine

Sub Investigator
Dominick J. Angiolillo, M.D., Ph.D., FACC
Medicine

Sub Investigator
Theodore A. Bass, M.D.
Medicine

Sub Investigator
John Pirris, M.D.
Surgery

Sub Investigator
Siva Suryadevara, M.B.B.S. (M.D.)
Medicine

Sub Investigator
Martin "M" Zenni, M.D.
Medicine