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Heart valve repair patients: which blood thinner is safest?

NCT ID NCT06901466

Disease control Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 880 people who had a minimally invasive heart valve repair and also need long-term blood thinners. It compares taking just one blood thinner (rivaroxaban) versus taking two (rivaroxaban plus clopidogrel) to see which causes fewer bleeding problems over one year. The goal is to find the safest option for these patients.

What this could mean

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

Active substance
Rivaroxaban and Clopidogrel (blood thinners)
What this could lead to
If it works, this could identify the safest blood thinner regimen after heart valve repair, reducing bleeding risks while preventing clots.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but the best strategy is unknown. Bleeding complications remain a risk, and results may not apply to all patients.

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 880 people

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

Started

Jun 2025

Expected to finish

Oct 2028

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Successful TEER procedure, defined as technical success per MVARC criteria. * Indication for long-term OAC. * Ability and willingness to comply with the trial protocol. * Provision of written informed consent. * Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy. * Antithrombotic strategy approved by the investigator. Exclusion Criteria: * Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis). * Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure. * Platelet count \< 50 × 10\^9 /L. * Need for reoperation due to complications of the index TEER procedure. * Recent ( \< 12 month) intracranial or intracerebral hemorrhage. * Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage. * Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis). * Allergy, intolerance, or contraindication to research drugs. * Participation in another investigational drug or device study within 30 days. * History of stroke or TIA within the past 6 weeks. * Absolute indication for anticoagulation in combination with antiplatelet therapy (eg, recent PCI). * Life expectancy \< 12 months. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Embolism and Thrombosis Hemorrhage mitral valve insufficiency myocardial infarction stroke disorder

As listed by the trial registrant

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

Mitral regurgitation

How to take part

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

  1. The places running it

    1 site. 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

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

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