Actively Recruiting
Randomized Evaluation of 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating long-term blood thinning treatment options in patients who have had a mechanical aortic valve replacement. This study compares an oral factor Xa inhibitor, Rivaroxaban, against the traditional vitamin K antagonist treatment, warfarin. The goal is to understand how these treatments affect heart-related events, valve function, and bleeding risks over time in adults aged 19 and older who meet specific heart function and valve criteria. Participants will be randomly assigned to one of two groups. One group will take Rivaroxaban oral tablets daily for 12 months, with dose adjustments for those with certain kidney function levels. The other group will receive vitamin K antagonist therapy, aiming to maintain a specific blood clotting level (INR) between 1.7 and 3.0 for 12 months. The study monitors these treatments without masking, observing effects on heart health and bleeding. During the study, participants will undergo assessments including heart imaging and blood tests to measure valve function and detect any heart or bleeding complications. Researchers will track events like heart-related death, valve thrombosis, stroke, and bleeding over one year. Safety and treatment effects will be reviewed regularly throughout the study period, which began in early 2022 and is expected to continue until late 2028.
CONDITIONS
Brief 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 condition: NYHA Functional Classification I or II, or confirmed proper valve function by VARC2 criteria with no prosthesis-patient mismatch and limited valve gradient or velocity, and no moderate or severe prosthetic valve regurgitation
- Voluntarily agree to participate with written consent
You will not qualify if you...
- Use of old-generation mechanical valve
- History of mechanical valve implantation in mitral, pulmonary, or tricuspid valves
- Valvular 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 less than 15 mL/min or on hemodialysis
- Left ventricular ejection fraction (LVEF) 40% or less
- Child-Pugh B or C hepatic impairment or hepatic disease with coagulopathy
- Active clinically significant bleeding
- Bleeding or hemorrhagic disorders
- High bleeding risk due to gastrointestinal ulcers, intracranial hemorrhage, vascular abnormalities, recent brain or spinal surgeries or injuries, esophageal varices, arteriovenous malformations, vascular aneurysms, or malignant tumors with bleeding risk
- Bleeding tendencies linked to active cancers or infections such as pericarditis or bacterial endocarditis
- Hemodynamically unstable or pulmonary embolism requiring thrombolysis or embolectomy
- Use of combination anticoagulants except specific permitted cases
- Uncontrolled moderate or severe hypertension
- Anemia with hemoglobin below 10.0 g/dL or platelet count below 100 x 10^9/L within 6 months, or ongoing anemia
- Infective endocarditis
- Hypersensitivity to Rivaroxaban or Vitamin K antagonist components
- Positive pregnancy test, pregnancy or lactation
- Genetic disorders affecting sugar metabolism
- Conditions unsuitable for the protocol
- Participation in another investigational drug or device study not completed primary endpoint follow-up
- Terminal illness with life expectancy under 12 months
- Vitamin K deficiency
- Alcoholic or psychiatric disorders
- Pregnancy complications like threatened abortion, eclampsia, or preeclampsia
- Use of antiplatelet therapy in patients with stroke or transient ischemic attack history for acute coronary syndrome treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive long-term anticoagulation treatment with either an oral Factor Xa inhibitor or a Vitamin K antagonist after mechanical aortic valve replacement.
Regular visits to monitor treatment and adjust dosing
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
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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