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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Clinique Pasteur Toulouse France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Nouvelles Cliniques Nimoises Nimes France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Saint Joseph Marseille France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Ifbdazjq Mlasyplqdq Mixwkwknmc Paris France
Bobqiist Uwlflalqfm Hkplsceb Cjuxof Besançon France
Ciew Dy Nnubq Vandoeuvre Les Nancy France
Ctfuexjy Ds Mrqokwieiv Montpellier France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.05.2025

Trial locations

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.

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 ID:
2024-516643-64-00
Protocol code:
APHP240889
Trial Phase:
Therapeutic confirmatory (Phase III)

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