This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,300
For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\_creatinine clearance 15-49 mL/min, 15mg once daily
For 12months, keep the international normalized ratio (INR) 1.7-3.0
Buchen Sejong Hospital
Bucheon-si, South Korea
RECRUITINGSeoul National University Bundang Hospital
Bundang, South Korea
Number of participants with the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. Clinically-relevant non-major bleeding is defined as BARC(Bleeding Academic Research Consortium) 2 Bleeding and major Bleeding is defined as BARC(Bleeding Academic Research Consortium) 3 or 5 Bleeding.
Time frame: 1 year
Number of Participants With all cause death
Time frame: 1 year
Number of Participants With cardiovascular death
Time frame: 1 year
Number of Participants With valve thrombosis confirmed by transthoracic echocardiography, transesophageal echocardiography, cine fluoroscopy, computed tomography, or autopsy (Valve Academic Research Consortium (VARC ) criteria)
Time frame: 1 year
Number of Participants With valve-related thromboembolic
Time frame: 1 year
Number of Participants With transient ischemic attack
Time frame: 1 year
Number of Participants With stroke
Time frame: 1 year
Number of Participants With systemic embolism
Time frame: 1 year
Number of Participants With myocardial infarction
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dong-A University Hospital
Busan, South Korea
RECRUITINGKeimyung University Dongsan Hospital
Daegu, South Korea
RECRUITINGGangNeung Asan Hospital
Gangneung, South Korea
RECRUITINGChonnam National University Hospital
Gwangju, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITING...and 5 more locations
Time frame: 1 year
Number of Participants With major bleeding
BARC (Bleeding Academic Research Consortium) 3 or 5
Time frame: 1 year
Number of Participants With Clinically-relevant non-major bleeding
BARC (Bleeding Academic Research Consortium) 2
Time frame: 1 year
Number of Participants With the composite of cardiac death, valve thrombosis and valve-related thromboembolic event
Time frame: 1 year
Number of Participants With the composite of cardiac death, valve thrombosis, stroke, systemic embolism and myocardial infarction event
Time frame: 1 year
Number of Participants With the composite event of major bleeding and clinically-relevant non-major bleeding
Clinically-relevant non-major bleeding is defined as BARC (Bleeding Academic Research Consortium) 2 Bleeding and major Bleeding is defined as BARC (Bleeding Academic Research Consortium) 3 or 5 Bleeding.
Time frame: 1 year
Number of Participants With the composite of stroke, systemic embolism, transient ischemic attack and myocardial infarction event
Time frame: 1 year
Number of Participants With the composite of all-cause death, stroke, systemic embolism, transient ischemic attack and myocardial infarction event
Time frame: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : transaortic valve mean gradient
Time frame: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : transaortic valve peak gradient
Time frame: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : transaortic valve peak velocity
Time frame: 1 year
The change of echocardiographic parameter
Integral ratio at baseline and 1 year follow-up : effective orifice area(EOA)
Time frame: 1 year