Valve Replacement Surgery
Conditions
Keywords
aspirin versus vitamin K antagonists
Brief summary
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).
Interventions
DRUGAspirin
100mg 1 tablet once daily for 6 months
Maintain an INR of 2.0 to 3.0 for 6 months
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 19 years with successful surgical bioprosthetic valve replacement 2. Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively 3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
1. Mechanical valve in any heart valve position 2. Previous hemorrhagic stroke within the last 3 months 3. Clinically overt stroke within the last 3 months 4. Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis) 5. Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamix support, disabling complications, stroke \[ischemic, embolic\], hemorrhagic stroke) 6. Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist 7. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 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. | From registration to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of all-cause mortality within 6 months | From registration to 6 months |
| Number of participants who experienced stroke within 6 months | From registration to 6 months |
| Number of participants who experienced transient ischemic attack within 6 months | From registration to 6 months |
| Number of participants who experienced systemic embolism within 6 months | From registration to 6 months |
| Number of participants who experienced myocardial infarction within 6 months | From registration to 6 months |
| Number of participants who experienced major bleeding within 6 months | From registration to 6 months |
| Number of participants with valve thrombosis at 6 months | From registration to 6 months |
Countries
Japan, South Korea
Contacts
CONTACTYU-KYUNG CHOI, RN
STUDY_DIRECTORJoon-Bum KIM, MD
jbkim1975@amc.seoul.kr
Outcome results
None listed