Actively Recruiting
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
Led by Joon Bum Kim · Updated on 2025-12-29
1300
Participants Needed
15
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
CONDITIONS
Official Title
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- At least 3 months after mechanical aortic valve replacement
- Meet at least one of: New York Heart Association Functional Classification I or II, or confirmed proper valve function without significant prosthetic valve problems
- Voluntarily agree to participate with written consent
You will not qualify if you...
- Use of old-generation mechanical valve
- History of mechanical valve in mitral, pulmonary, or tricuspid valves
- Valvular atrial fibrillation (atrial fibrillation with moderate or severe mitral stenosis)
- Moderate to severe mitral stenosis or regurgitation
- History of hemorrhagic stroke
- Stroke within the last 3 months
- Renal failure with creatinine clearance under 15 mL/min or on dialysis
- Left ventricular ejection fraction 40% or less
- Moderate or severe liver impairment or liver disease with bleeding risk
- Active significant bleeding or bleeding disorders
- High bleeding risk conditions such as recent ulcers, brain or spinal surgery or injury within 6 months, esophageal varices, vascular abnormalities, or cancers with bleeding risk
- Bleeding tendencies linked to certain cancers or infections
- Unstable condition requiring thrombolysis or embolectomy for pulmonary embolism
- Use of other anticoagulants except for allowed switching or line maintenance
- Uncontrolled moderate or severe high blood pressure
- Anemia with hemoglobin below 10.0 g/dL or low platelets within 6 months
- Infective endocarditis
- Allergy to Rivaroxaban or Vitamin K antagonist components
- Pregnancy, lactation, or positive pregnancy test before enrollment
- Genetic conditions affecting sugar metabolism
- Unsuitable condition for the study protocol
- Participation in another investigational drug or device study not completed primary follow-up
- Terminal illness with life expectancy less than 12 months
- Vitamin K deficiency
- Alcoholic or psychiatric disorders
- Pregnancy complications such as threatened abortion, eclampsia, or preeclampsia
- Use of antiplatelet drugs in patients with history of stroke or transient ischemic attack for acute coronary syndrome treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Buchen Sejong Hospital
Bucheon-si, South Korea
Actively Recruiting
2
Seoul National University Bundang Hospital
Bundang, South Korea
Not Yet Recruiting
3
Dong-A University Hospital
Busan, South Korea
Actively Recruiting
4
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
5
GangNeung Asan Hospital
Gangneung, South Korea
Actively Recruiting
6
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
7
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
8
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
9
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
10
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
11
Ajou University Hospital
Suwon, South Korea
Actively Recruiting
12
St. Vincent's Hospital, Catholic University of Korea
Suwon, South Korea
Not Yet Recruiting
13
Eulji University Uijeongbu Hospital
Uijeongbu-si, South Korea
Not Yet Recruiting
14
Ulsan University Hospital
Ulsan, South Korea
Not Yet Recruiting
15
Pusan National University Yangsan Hospital
Yangsan, South Korea
Actively Recruiting
Research Team
J
Jung-hee Ham, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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