Study on Rivaroxaban, Dabigatran Etexilate, and Fluindione for Patients with Intra-Cardiac Thrombus

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What is this study about?

This clinical trial is focused on studying treatments for a condition known as intra-cardiac thrombus, which refers to blood clots that form inside the heart. The study will compare different types of medications used to treat this condition. The medications being tested include Rivaroxaban (also known by its code name BAY59-7939), Dabigatran Etexilate, Apixaban, Fluindione, Acenocoumarol, and Warfarin. These medications are all taken orally, meaning they are swallowed in pill form.

The purpose of the study is to evaluate the impact of these medications on the overall health of patients with intra-cardiac thrombus over a period of six months. Participants in the study will be randomly assigned to receive one of the medications or a placebo. The study will monitor the effects of the medications on the reduction of blood clots and any potential side effects, such as bleeding. The goal is to determine which medication provides the best balance of benefits and risks for patients.

Throughout the study, participants will undergo regular check-ups and imaging tests, such as echocardiography or cardiac MRI, to assess the presence and size of the blood clots. The study will last for up to six months, during which time the participants’ health and response to the treatment will be closely monitored. The findings from this study aim to improve the treatment options available for patients with intra-cardiac thrombus, ultimately enhancing their quality of life and health outcomes.

1 joining the study

Upon joining the study, the patient is confirmed to have a non-device related intra-cardiac thrombus diagnosed through imaging techniques such as echocardiography, cardiac CT-scanner, or cardiac magnetic resonance imaging.

The patient must be at least 18 years old and have not used anticoagulant medication for at least 3 months prior to the study.

2 medication administration

The patient will be randomly assigned to receive either a direct oral anticoagulant (DOA) or a vitamin K antagonist (VKA) as part of the treatment regimen.

Medications include rivaroxaban, dabigatran etexilate, apixaban, fluindione, warfarin sodium, and acenocoumarol, all administered orally.

3 treatment duration

The treatment will be administered over a period of 6 months, during which the impact of the medication on thrombus regression and clinical outcomes will be evaluated.

4 follow-up assessments

Follow-up assessments will occur at 6 and 12 months to evaluate the primary and secondary endpoints.

Primary endpoints include the net clinical benefit, which is a composite of all-cause death, myocardial infarction, stroke, embolic events, thrombus persistence, and significant bleeding events.

Secondary endpoints include individual components of ischemic events, systemic embolism, cardiovascular death, thrombus regression, and recurrence, as well as safety endpoints related to bleeding.

5 completion of the study

The study is estimated to conclude by November 30, 2026, with all data collected and analyzed to determine the effectiveness and safety of the anticoagulant regimens.

Who Can Join the Study?

The patient must have an intra-cardiac thrombus, which is a blood clot inside the heart, not related to any medical device. This can be in any of the four chambers of the heart and should be diagnosed using tests like echocardiography, cardiac CT scan, or cardiac MRI, regardless of any existing heart disease.
The patient must be 18 years or older, regardless of gender or ethnic background.
The patient should not have taken any blood-thinning medication, known as anticoagulants, for at least the past 3 months.
The patient must be part of a health insurance program.
The patient must agree not to participate in other studies that involve taking a study medication until after a one-year follow-up visit. Participation in registries and studies that do not involve taking a study drug is allowed.
The patient must sign a consent form, indicating they understand and agree to participate in the study.

Who Cannot Join the Study?

Presence of an intra-cardiac thrombus, which is a blood clot inside the heart.
Age outside the specified range for the study.
Belonging to a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nimes	Nimes	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.05.2023

Trial locations

Investigated drugs:

Direct Oral Anticoagulant (DOA) is a type of medication used to prevent blood clots. In this trial, it is being tested to see how well it helps dissolve blood clots inside the heart and improve patient outcomes over six months. These medications work by directly inhibiting specific factors in the blood clotting process, making them effective in reducing the risk of stroke and other complications related to blood clots.

Vitamin K Antagonist (VKA) is another type of medication used to prevent blood clots. It works by reducing the action of vitamin K, which is necessary for blood clotting. In this trial, VKA is used as a reference treatment to compare its effectiveness and safety against the direct oral anticoagulant in patients with blood clots inside the heart.

Intra-cardiac thrombus – This condition involves the formation of a blood clot within the chambers of the heart. It can occur due to various factors, including heart rhythm disorders, heart valve issues, or after a heart attack. The thrombus can obstruct blood flow within the heart, potentially leading to complications. Over time, the clot may dissolve on its own, remain stable, or increase in size. If the thrombus dislodges, it can travel to other parts of the body, causing embolism. Monitoring and management are essential to prevent further complications.

Trial ID:

2024-512685-33-00

Protocol code:

PHRC-N/2020/BL-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Rivaroxaban, Dabigatran Etexilate, and Fluindione for Patients with Intra-Cardiac Thrombus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?