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Could dropping aspirin cut bleeding in LVAD patients?

NCT ID NCT06655376

Disease control Sponsor: Columbia University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at 128 people with advanced heart failure who have a HeartMate3 heart pump. All take warfarin to prevent clots, and half will also stop taking aspirin. The goal is to see if skipping aspirin lowers the risk of serious bleeding without raising the chance of dangerous clots or strokes.

What this could mean

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

Active substance
Aspirin and warfarin
What this could lead to
If successful, this could show that many LVAD patients can safely avoid aspirin, lowering their risk of serious bleeding without increasing clots.
What could go wrong
This is a relatively small Phase 4 trial (128 people) and only includes patients already stable on an LVAD for over 3 months, so results may not apply to everyone. Skipping aspirin might still raise clot risk in some individuals.

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 128 people

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

Started

Oct 2024

Expected to finish

Apr 2027

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

18 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: * Participant will have HeartMate3 LVAD implanted \> 3 months before enrollment. * \>18 years old * Treated with aspirin and VKA * Participant must provide written informed consent prior to any clinical investigation-related procedure Exclusion Criteria: * Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent) * Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results * Pregnant and on appropriate contraception

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Conditions

The condition(s) this trial relates to.

advanced heart failure Hemorrhage hemorrhagic disease thrombotic disease

As listed by the trial registrant

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

Bleeding Clot blood

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. 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

  • Columbia Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

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