Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
⁃ According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient \<20 mm Hg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation
• Voluntarily participated in the written agreement
Locations
Other Locations
Republic of Korea
Buchen Sejong Hospital
RECRUITING
Bucheon-si
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Bundang
Dong-A University Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
GangNeung Asan Hospital
RECRUITING
Gangneung
Chonnam National University Hospital
RECRUITING
Gwangju
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
St. Vincent's Hospital, Catholic University of Korea
NOT_YET_RECRUITING
Suwon
Eulji University Uijeongbu Hospital
NOT_YET_RECRUITING
Uijeongbu-si
Ulsan University Hospital
NOT_YET_RECRUITING
Ulsan
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Contact Information
Primary
Jung-hee Ham, RN
cvcrc5@amc.seoul.kr
82230104728
Time Frame
Start Date: 2022-02-21
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 1300
Treatments
Experimental: Oral Factor Xa inhibitor
Active_comparator: Vitamin K antagonist
Authors
Hyoung-gon Je
Related Therapeutic Areas
Sponsors
Leads: Joon Bum Kim