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Heart valve patients may ditch blood thinners for simple aspirin

NCT ID NCT07431762

Disease control Sponsor: Asan Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study compares aspirin to the blood thinner warfarin in 1058 people who just had a bioprosthetic heart valve replacement. For 6 months after surgery, participants take either daily aspirin or warfarin. The goal is to see if aspirin is just as safe and effective at preventing blood clots, strokes, and other complications, potentially offering a simpler treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aspirin or warfarin
What this could lead to
If aspirin works as well as warfarin, patients could avoid the frequent blood tests and dietary restrictions needed with warfarin.
What could go wrong
This is a phase 4 trial, so the drugs are already approved, but it's still possible that aspirin is less effective at preventing clots, which could increase stroke risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,058 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged ≥ 19 years with successful surgical bioprosthetic valve replacement 2. Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively 3. 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: 1. Mechanical valve in any heart valve position 2. Previous hemorrhagic stroke within the last 3 months 3. Clinically overt stroke within the last 3 months 4. Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis) 5. Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamic support, disabling complications, stroke \[ischemic, embolic\], hemorrhagic stroke) 6. Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist 7. Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

heart valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Valve replacement surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • National Cerebral and Cardiovascular Center Hospital

    NOT_YET_RECRUITING

    Osaka, 564-8565, Japan

  • Osaka University Hospital

    NOT_YET_RECRUITING

    Osaka, 565-0871, Japan

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