Recruiting NCT07431762
Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspirin, Vitamin K antagonist(warfarin).
- Who it may be relevant to
- Registry conditions: Valve Replacement Surgery. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Aspirin
100mg 1 tablet once daily for 6 months - Drug Vitamin K antagonist(warfarin)
Maintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months
Primary outcome measures
- 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. [Time frame: From registration to 6 months]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- Aged ≥ 19 years with successful surgical bioprosthetic valve replacement
- Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively
- 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
- Mechanical valve in any heart valve position
- Previous hemorrhagic stroke within the last 3 months
- Clinically overt stroke within the last 3 months
- Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis)
- Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamic support, disabling complications, stroke \[ischemic, embolic\], hemorrhagic stroke)
- Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist
- Pregnant or lactating women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 2 centers
- National Cerebral and Cardiovascular Center Hospital — Osaka
- Osaka University Hospital — Osaka
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT07431762 · 2025-1499