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Study Comparing Apixaban and Carbasalate Calcium for Patients with Aortic Valve Replacement Due to Heart Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients who have undergone surgery to replace their aortic valve with a bioprosthetic valve due to valvular heart disease. The purpose of the study is to compare two treatments to see which is more effective in preventing complications. The treatments being compared are apixaban, a medication that helps prevent blood clots, and aspirin, which is commonly used to reduce the risk of heart attacks and strokes.

Participants in the study will be randomly assigned to receive either apixaban or aspirin. The study will last for about 120 days, during which time the health of the participants will be closely monitored. The main goal is to see if apixaban is better than aspirin at preventing serious health problems such as death, heart attacks, strokes, blood clots in the lungs or veins, and issues with the new heart valve.

Throughout the study, the safety of the participants will be a priority, and any side effects, especially bleeding, will be carefully tracked. The study aims to provide valuable information that could improve the care of patients with bioprosthetic aortic valves in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written consent, confirming your understanding and agreement to participate.

    You must be at least 18 years old and have had a bioprosthetic valve implanted in the aortic position at least 7 days ago and before leaving the hospital.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either apixaban or aspirin as part of the study treatment.

    Apixaban is taken orally in the form of a 5 mg film-coated tablet, while aspirin is also taken orally.

  3. Step 3

    Treatment period

    The treatment will last for approximately 105 days, with a possible variation of 15 days.

    During this period, you will take the assigned medication as directed by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be monitored to assess the effectiveness and safety of the treatment.

    The primary goal is to evaluate the occurrence of events such as death, heart attack, stroke, blood clots, and valve-related issues.

  5. Step 5

    Completion of the study

    At the end of the treatment period, the study team will evaluate the results to determine the effectiveness of the treatment.

    You will be informed about the findings related to your participation in the study.

Who can join the trial?

5 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have had a bioprosthetic valve placed in the aortic position at least 7 days ago and before leaving the hospital. A bioprosthetic valve is a type of heart valve made from animal tissue used to replace a damaged valve.
  • Must not need ongoing treatment with blood thinners for other conditions like atrial fibrillation (an irregular heartbeat), pulmonary embolism (a blood clot in the lungs), or any other condition.
  • Must be affiliated with social security.
  • Must be able to provide free, informed, and written consent to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who have not had a recent surgical replacement of the aortic valve with a bioprosthetic valve cannot participate. A bioprosthetic valve is a type of heart valve made from animal tissue used to replace a damaged valve.
  • Patients who are not taking antithrombotic treatment with apixaban or aspirin cannot participate. Antithrombotic treatment refers to medication that helps prevent blood clots.
  • Patients who are not at risk for conditions like death, heart attack, stroke, blood clots in the body, deep vein thrombosis, or pulmonary embolism cannot participate. Deep vein thrombosis is a blood clot in a deep vein, usually in the legs. Pulmonary embolism is a blockage in one of the pulmonary arteries in the lungs.
  • Patients who have not experienced valve thrombosis cannot participate. Valve thrombosis is a blood clot that forms on a heart valve.
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Investigated drugs

  • Apixaban

    is a medication used in this study to help prevent blood clots. It is an anticoagulant, which means it works by making it harder for your blood to form clots. This can be especially important for patients who have had a recent surgery to replace a heart valve, as they are at a higher risk of developing clots. The goal of using apixaban in this trial is to see if it is better than aspirin at preventing serious problems like heart attacks, strokes, or clots in the lungs or legs.

  • Aspirin

    is another medication used in this study. It is commonly known for its ability to relieve pain and reduce fever, but it also has properties that help prevent blood clots. In this trial, aspirin is being used as a comparison to see if it is as effective as apixaban in preventing blood clots and other related complications in patients who have had a heart valve replacement surgery. The study aims to determine which medication is more effective in reducing the risk of serious health issues like heart attacks and strokes.

What is already known about the treatment

Apixaban – Apixaban is a medication taken orally, usually in the form of a tablet, and is used to prevent blood clots. It is currently being studied in clinical trials for its effectiveness in patients who have had a surgical bioprosthetic aortic valve replacement, a condition related to heart valve disease. The main therapeutic use of apixaban is to reduce the risk of serious complications like heart attacks, strokes, and blood clots in the lungs or legs. At the molecular level, apixaban works by inhibiting a specific protein in the blood called Factor Xa, which plays a crucial role in the formation of blood clots. It is classified as an anticoagulant, which means it helps to prevent the blood from clotting too easily.

Investigated diseases

Valvular Heart Disease – Valvular heart disease involves damage to one or more of the heart's valves, affecting how blood flows through the heart. The condition can lead to the valves not opening fully or not closing completely, causing blood to leak backward. Over time, this can result in the heart working harder to pump blood, potentially leading to heart enlargement and weakening. Symptoms may include shortness of breath, fatigue, and irregular heartbeats. The progression of the disease can vary, with some individuals experiencing rapid changes while others may have a slower progression. Regular monitoring is essential to assess the condition's impact on heart function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516643-64-00Protocol codeAPHP240889Estimated enrolment1 500 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).