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 study about?

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.

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 randomization

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

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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Clinique Pasteur Toulouse France
Frisius Heerenveen The Netherlands
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Az Maria Middelares Gent Gent Belgium
Assistance Publique Hopitaux De Paris Paris France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Stichting Radboud University Medical Center Nijmegen The Netherlands
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Amphia Hospital Breda The Netherlands
Roskilde University Roskilde Denmark
AZ Delta uw Ziekenhuis Campus Rumbeke, campus Brugsesteenweg Roeselare Roeselare Belgium
Imelda Hospital Bonheiden Bonheiden Belgium
Uxknzaxkdmjy Mfqttyd Cqpacmx Gfsczazyf Groningen The Netherlands
Brxcffwq Ugtrrcyfuz Hryxtshn Cuzobd Besançon France
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Ujcxequnxb Od Amcmasw Edegem Belgium
Lmdkc Upnzaxheehsr Mymkrfv Ccyjwlc (axvvz Leiden The Netherlands
Uhcxjokeae Hiqjocozv Pymua Sccsjgwqucj Chmmslr Fqdc Paris France
Hemvpli Jsymlo Cpkysiy Mixhx Massy France
Hjiqnuwq Uigotpygusxvvv Sdzkxpmriu &bkyskh Hwwmupe dt Hhmsjolffti STRASBOURG, Alsace France
Sciwqdz Dxduwkptqyymnbhytgwa Dz Codwsq Cgvakemndneat Do Neoh St Denis France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.09.2023
Denmark Denmark
Recruiting
01.09.2023
France France
Recruiting
01.09.2023
Germany Germany
Not yet recruiting
01.09.2023
The Netherlands The Netherlands
Recruiting
01.09.2023

Trial locations

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.

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 ID:
2023-504637-42-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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