This trial is a multinational, multicenter, randomized, open-label, active-controlled clinical trial comparing the safety of aspirin versus vitamin K antagonists (warfarin) as oral antithrombotic therapy during the initial 6 months following tissue valve replacement (aortic or mitral).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,058
100mg 1 tablet once daily for 6 months
Maintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months
National Cerebral and Cardiovascular Center Hospital
Osaka, Japan
NOT_YET_RECRUITINGOsaka University Hospital
Osaka, Japan
NOT_YET_RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGA composite endpoint is defined as a single outcome that combines multiple clinical events; the occurrence of any one of the component events is considered as meeting the endpoint.
Time frame: From registration to 6 months
Rate of all-cause mortality within 6 months
Time frame: From registration to 6 months
Number of participants who experienced stroke within 6 months
Time frame: From registration to 6 months
Number of participants who experienced transient ischemic attack within 6 months
Time frame: From registration to 6 months
Number of participants who experienced systemic embolism within 6 months
Time frame: From registration to 6 months
Number of participants who experienced myocardial infarction within 6 months
Time frame: From registration to 6 months
Number of participants who experienced major bleeding within 6 months
Time frame: From registration to 6 months
Number of participants with valve thrombosis at 6 months
Time frame: From registration to 6 months
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