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NCT Number: NCT07431762

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

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).

Recruiting

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Key information

Conditions

Valve Replacement Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cerebral and Cardiovascular Center Hospital, Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

100mg 1 tablet once daily for 6 months

Vitamin K antagonist(warfarin)

Drug

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

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.

    Time frame: From registration to 6 months

Secondary outcomes

  1. Rate of all-cause mortality within 6 months

    Time frame: From registration to 6 months

  2. Number of participants who experienced stroke within 6 months

    Time frame: From registration to 6 months

  3. Number of participants who experienced transient ischemic attack within 6 months

    Time frame: From registration to 6 months

  4. Number of participants who experienced systemic embolism within 6 months

    Time frame: From registration to 6 months

  5. Number of participants who experienced myocardial infarction within 6 months

    Time frame: From registration to 6 months

  6. Number of participants who experienced major bleeding within 6 months

    Time frame: From registration to 6 months

  7. Number of participants with valve thrombosis at 6 months

    Time frame: From registration to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Joon-bum Kim, MD

CONTACT

[email protected]

82230105416

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Acronym: CONCLAVE

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Feb 25, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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