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New treatment option for Valve Replacement Surgery
Official title Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement
ClinicalTrials.gov ID: NCT07431762
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for valve replacement surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Osaka, Japan
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Osaka, Japan; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.