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

NCT07431762 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1058

Last updated 2026-02-25

No results posted yet for this study

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).

Conditions

  • Valve Replacement Surgery

Interventions

DRUG

Aspirin

100mg 1 tablet once daily for 6 months

DRUG

Vitamin K antagonist(warfarin)

Maintain an INR of 2.0 to 3.0 for 6 months

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2030-10-31
Completion
2031-03-31

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07431762 on ClinicalTrials.gov