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Clinical Trials/NCT07431762
NCT07431762
Not yet recruiting
Phase 4

Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Heart Valve Replacement

Asan Medical Center3 sites in 2 countries1,058 target enrollmentStarted: February 1, 2026Last updated:
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InterventionsAspirinVitamin K antagonist(warfarin)

Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
1,058
Locations
3
Primary Endpoint
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.
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 hemodynamix 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

Arms & Interventions

Aspirin

Experimental

Antiplatelet Agent

Intervention: Aspirin (Drug)

wafarin

Active Comparator

Vitamin K antagonist

Intervention: Vitamin K antagonist(warfarin) (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joon Bum Kim

Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine

Asan Medical Center

Study Sites (3)

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