Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorJoon Bum Kim
About this trial
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
Eligibility criteria
Qualifiers
Age 19 and more
At least 3 months after mechanical aortic valve replacement
At least one of the conditions(as defined below) is met
The New York Heart Association (NYHA) Functional Classification I or II; or
Disqualifiers
Old-generation mechanical valve
History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve
Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis)
Moderate to severe mitral stenosis or regurgitation
Trial design
Treatments tested in this trial
- Rivaroxaban Oral Tablet
- Vitamin K antagonist(warfarin)
Treatment groups
1,300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Joon Bum Kim
Lead sponsor
Asan Medical Center
Sponsor institution
Source ClinicalTrials.gov