NCT07431762

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,058

participants targeted

Target at P75+ for phase_4

Timeline
57mo left

Started Jun 2026

Longer than P75 for phase_4

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Mar 2031

First Submitted

Initial submission to the registry

December 11, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2031

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

4.4 years

First QC Date

December 11, 2025

Last Update Submit

July 2, 2026

Conditions

Valve Replacement Surgery

Keywords

aspirin versus vitamin K antagonists

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Aspirin

EXPERIMENTAL

Antiplatelet Agent

Drug: Aspirin

warfarin

ACTIVE COMPARATOR

Vitamin K antagonist

Drug: Vitamin K antagonist(warfarin)

Interventions

AspirinDRUG

100mg 1 tablet once daily for 6 months

Aspirin
Vitamin K antagonist(warfarin)DRUG

Maintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months

warfarin

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify 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 \[ischemic, embolic\], hemorrhagic stroke)
  • Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cerebral and Cardiovascular Center Hospital

Osaka, 564-8565, Japan

NOT YET RECRUITING

Osaka University Hospital

Osaka, 565-0871, Japan

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Joon-Bum KIM, MD

    jbkim1975@amc.seoul.kr

    STUDY DIRECTOR

Central Study Contacts

Joon-bum Kim, MD

CONTACT

82230105416jbkim1975@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine

Study Record Dates

First Submitted

December 11, 2025

First Posted

February 25, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

October 31, 2030

Study Completion (Estimated)

March 31, 2031

Last Updated

July 6, 2026

Record last verified: 2026-07

Locations

JP(2)KR(1)