Currently, warfarin is the only approved anticoagulation for patients with mechanical valves.
The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve
/ On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X
aortic valve and apixaban have been approved for use by the US Food and Drug Administration
(FDA) but they have not been approved to be used together.
There is an unmet clinical need for an alternative to warfarin, such as a direct oral
anticoagulant (DOAC), as anticoagulation in participants with an aortic mechanical prosthetic
valve. Some participants may be genetically hyper- or hypo-responsive to warfarin, which
makes management difficult. Another small group of participants is allergic to warfarin. A
much larger group of participants has difficulty maintaining warfarin control due to dietary
and drug interactions. Finally, the requirement for routine blood testing makes people
reluctant to take warfarin. All of these factors drive younger participants in need of aortic
valve replacement (AVR) toward selection of a tissue valve instead of a mechanical valve.
Despite multiple studies (randomized, matched and risk adjusted) that show that tissue valves
are associated with worse outcomes, younger participants choose this type of valve to avoid
warfarin. In addition, multiple clinical studies have shown valve reoperation rates are
higher for tissue valves used in these younger participants. Providing an alternative to
warfarin anticoagulation may lead younger participants to choose a mechanical valve with
greater durability and better clinical outcomes.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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