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New blood thinner may simplify life after valve replacement

NCT ID NCT04258488

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a newer blood thinner (rivaroxaban) works as well as the standard drug (warfarin) for preventing clots and bleeding in people who have a mechanical aortic valve. About 1,300 adults who had valve surgery at least 3 months ago will take one of the two pills daily for a year. The goal is to see which drug better prevents serious heart problems and bleeding complications.

What this could mean

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

Active substance
Rivaroxaban (oral blood thinner)
What this could lead to
If successful, this could offer a simpler, more predictable blood-thinning option for people with mechanical aortic valves, potentially reducing the need for frequent blood tests.
What could go wrong
This is a phase 4 trial, so the drug is already approved for other uses, but its safety and effectiveness for this specific valve type are not yet proven. There is a risk of bleeding or clotting events.

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 1,300 people

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

Started

Feb 2022

Expected to finish

Dec 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

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. Age 19 and more 2. At least 3 months after mechanical aortic valve replacement 3. At least one of the conditions(as defined below) is met * The New York Heart Association (NYHA) Functional Classification I or II; or * According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient \<20 mm Hg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation 4. Voluntarily participated in the written agreement Exclusion Criteria: 1. Old-generation mechanical valve 2. History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve 3. Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis) 4. Moderate to severe mitral stenosis or regurgitation 5. History of hemorrhagic stroke 6. Clinically overt stroke within the last 3 months 7. Renal failure(creatinine clearance \<15mL/min) or on hemodialysis 8. Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40% 9. Child-Pugh B and C hepatic impairment or any hepatic disease associated with coagulopathy 10. Clinically significant active bleeding 11. Bleeding or hemorrhagic disorder 12. The increased risk of bleeding due to the following reasons 1. History of gastrointestinal ulcers or active ulcerations within the last 6 months 2. History of intracranial or intracerebral hemorrhage within the last 6 months 3. Spinal cord vascular abnormalities or intracerebral vascular abnormalities 4. History of the brain, spinal cord, or ophthalmic surgery within the last 6 months 5. History of the brain or spinal cord injury within the last 6 months 6. History of the brain or spinal cord injury or spinal tap, major regional anesthesia, or spinal anesthesia within the last 6 months 7. Esophageal varices 8. Arteriovenous malformation 9. Vascular aneurysms 10. Malignant tumor with a high risk of bleeding 13. Bleeding tendencies associated with overt bleeding of 1. gastrointestinal, genitourinary, respiratory tract, or colorectal cancer 2. cerebrovascular hemorrhage 3. aneurysms- cerebral, dissecting aorta 4. pericarditis and pericardial effusions 5. bacterial endocarditis 14. Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy 15. Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted * Switching anticoagulants * Intravenous UFH to keep central/arterial lines open 16. Uncontrolled moderate or severe hypertension 17. Anemia at least one among the conditions(as defined below) is met 1) Hemoglobin level \<10.0 g/dL or platelet count \< 100 x 10x9/L within the last 6 months 2) Diagnosed and documented ongoing anemia 18. Infective endocarditis 19. Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist 20. Positive pregnancy test results (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days before screening and/or randomization) or during pregnancy or lactation 21. A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 22. The unsuitable condition of the protocol 23. Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period 24. Terminal illness with life expectancy \<12 months 25. Vitamin K deficiency 26. Alcoholic or psychical disorder 27. Threatened abortion, eclampsia, or preeclampsia 28. Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of the acute coronary syndrome

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    16 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

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, 138-736, South Korea

  • Buchen Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Dong-A University Hospital

    RECRUITING

    Busan, South Korea

  • Eulji University Uijeongbu Hospital

    RECRUITING

    Uijeongbu-si, South Korea

  • GangNeung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • St. Vincent's Hospital, Catholic University of Korea

    NOT_YET_RECRUITING

    Suwon, South Korea

  • Ulsan University Hospital

    NOT_YET_RECRUITING

    Ulsan, South Korea

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Other studies related to the condition(s) this trial covers.