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Study on Personalized Antithrombotic Therapy with Acenocoumarol, Phenprocoumon, and Apixaban for Patients with Aortic Valve Stenosis Post-TAVI

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What is this trial about?

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

This clinical trial is focused on patients with aortic valve stenosis, a condition where the valve between the heart and the main artery becomes narrowed, affecting blood flow. The study aims to compare two different approaches to prevent blood clots and bleeding after a procedure called transcatheter aortic valve implantation (TAVI). One approach uses a personalized treatment plan guided by computed tomography (CT) scans, while the other uses a standard lifelong single antiplatelet therapy. Antiplatelet therapy involves medications that help prevent blood cells called platelets from clumping together to form clots.

The medications being studied include Acenocoumarol, Fenprocoumon, Prasugrel, Apixaban, Clopidogrel, Warfarin, Ticagrelor, and Acetylsalicylic Acid (commonly known as aspirin). Some participants will receive these medications, while others may receive a placebo. The purpose of the study is to determine if the personalized treatment plan is more effective in reducing the risk of heart-related deaths, blood clots, and bleeding events compared to the standard treatment.

Participants in the study will be randomly assigned to one of the two treatment groups. They will be monitored over time to assess the occurrence of any heart-related events, blood clots, or bleeding. The study will also evaluate the overall health and quality of life of participants, as well as their adherence to the medication regimen. The trial is expected to continue until 2027, with regular follow-ups to gather comprehensive data on the effectiveness and safety of the treatments being tested.

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, participation begins after a successful transcatheter aortic valve implantation (TAVI).

    Understanding and compliance with the study protocol are required, along with providing written informed consent.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: personalized, CT-guided antithrombotic therapy or lifelong single antiplatelet therapy (SAPT).

  3. Step 3

    Medication administration

    If assigned to the personalized therapy group, medications may include acenocoumarol, phenprocoumon, prasugrel, apixaban, clopidogrel, warfarin sodium, ticagrelor, or acetylsalicylic acid. These are taken orally in tablet form.

    The specific medication, dosage, and frequency depend on individual needs as determined by CT-guided assessment.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor health outcomes, including cardiovascular events and bleeding.

    Yearly evaluations include echocardiography to assess aortic valve function and quality of life surveys.

  5. Step 5

    End of study

    The study is estimated to conclude by September 2027.

    Final assessments will be conducted to evaluate the effectiveness of the treatment strategy.

Who can join the trial?

5 criteria

  • The patient must have had a successful TAVI. TAVI stands for Transcatheter Aortic Valve Implantation, which is a procedure to replace a narrowed heart valve.
  • The patient must be able to understand and follow the study protocol, which means they need to be able to follow the instructions and procedures of the study.
  • The patient must provide written informed consent, which means they agree to participate in the study after being informed about it.
  • Both male and female patients can participate.
  • The study is not specifically for vulnerable populations, meaning it is not designed for groups that might need special protection.

Who cannot join the trial?

3 criteria

  • Patients with a history of aortic valve stenosis cannot participate. This is a condition where the valve between the heart and the main blood vessel to the body becomes narrowed.
  • Patients who have an existing need for OAC (oral anticoagulation) are excluded. Oral anticoagulation is a treatment to prevent blood clots.
  • Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • Antithrombotic Therapy

    This therapy involves using medications that help prevent blood clots from forming. In this trial, the antithrombotic therapy is personalized and guided by CT scans to ensure it is tailored to each patient's needs. The goal is to reduce the risk of cardiovascular problems, such as heart attacks or strokes, and to minimize bleeding events after a heart valve procedure.

  • Single Antiplatelet Therapy (SAPT)

    This therapy uses a single medication to prevent platelets in the blood from clumping together and forming clots. It is a standard treatment given for life to patients who have undergone certain heart procedures. In this trial, SAPT is used as a comparison to see if the personalized antithrombotic therapy is more effective in preventing complications.

What is already known about the treatment

Antithrombotic Therapy – This medication is administered orally and is used to prevent blood clots. It is currently being studied in clinical trials to determine its effectiveness in reducing cardiovascular mortality and thromboembolic events in patients who have undergone transcatheter aortic valve implantation (TAVI) and do not have atrial fibrillation. The main therapeutic indication is to prevent clot-related complications in these patients. At the molecular level, it works by inhibiting platelet aggregation, which reduces the formation of clots. It is classified as an antiplatelet medication.

Investigated diseases

Aortic Valve Stenosis – Aortic valve stenosis is a condition where the valve between the heart's left ventricle and the aorta becomes narrowed. This narrowing restricts blood flow from the heart to the rest of the body, causing the heart to work harder to pump blood. Over time, this increased workload can lead to symptoms such as chest pain, fatigue, and shortness of breath. As the condition progresses, it may result in fainting or heart failure. The severity of symptoms often correlates with the degree of valve narrowing. Regular monitoring is essential to assess the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504637-42-01Estimated enrolment2 600 patientsSponsorSt Antonius Hospital

sourced from the EU Clinical Trials Register and site verification

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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).