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Study on Blood Thinners Rivaroxaban, Clopidogrel, and Aspirin for Patients with Heart Defects Undergoing Closure Procedures

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What is this study about?

This clinical trial is focused on studying patients with a heart condition known as patent foramen ovale or atrial septal defect. These conditions involve a small opening in the heart that can lead to complications if not treated. The study will explore the effects of different medications used after a procedure to close this opening. The medications being studied include Xarelto (rivaroxaban), Plavix (clopidogrel), and a combination of acetylsalicylic acid (commonly known as aspirin) and caffeine citrate.

The purpose of the study is to evaluate how these medications affect blood clotting and platelet activity after the heart procedure. Participants will be randomly assigned to receive one of these treatments or a placebo. The study will monitor how well the blood clots and how active the platelets are, which are small blood cells that help with clotting. This will help determine the best treatment approach for patients undergoing this heart procedure.

Participants will take the assigned medication for a period of time after their procedure, and their blood will be tested to measure various factors related to clotting and platelet activity. The study aims to provide valuable information on the effectiveness and safety of these treatments, which could improve care for patients with these heart conditions.

1 joining the study

Upon joining the study, the participant is required to provide written informed consent, confirming understanding and willingness to participate.

Eligibility is confirmed based on age (18 years or older) and the need for a procedure to close a patent foramen ovale or atrial septal defect.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s health status and suitability for the trial.

This includes a review of medical history and any necessary baseline tests.

3 procedure

The participant undergoes a catheter-based procedure to close the patent foramen ovale or atrial septal defect.

This is a minimally invasive procedure performed by a healthcare professional.

4 medication regimen

Following the procedure, the participant is assigned to a medication regimen.

One group receives Xarelto (rivaroxaban) 20 mg film-coated tablets, taken orally once daily.

Another group receives Plavix (clopidogrel) 75 mg film-coated tablets, taken orally once daily, along with acetylsalicylic acid (aspirin) as directed by the healthcare provider.

5 follow-up assessments

Regular follow-up assessments are conducted to monitor the participant’s response to the medication and overall health.

These assessments include blood tests to evaluate coagulation and platelet activity, such as measuring prothrombin fragment 1+2, thrombin antithrombin III complex, and other related factors.

6 completion of study

The study is estimated to conclude by January 1, 2026.

Upon completion, participants may receive a summary of their health outcomes and any relevant findings from the study.

Who Can Join the Study?

  • The person must be 18 years or older.
  • The person is scheduled for a percutaneous closure of a PFO or ASD. This means a doctor has planned a procedure to close a small hole in the heart using a thin tube.
  • The person must be able to understand the study and agree to participate by signing a form. This is called providing written informed consent.

Who Cannot Join the Study?

  • Patients with a patent foramen ovale or atrial septum defect cannot participate. These are conditions where there is an opening in the heart that didn’t close the way it should after birth.

Where you can join this trial?

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Other Sites

Site Name City Country Status
St. Antonius Ziekenhuis Nieuwegein The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
29.04.2024

Trial locations

Investigated drugs:

Rivaroxaban is a medication used in this study to help prevent blood clots. It is a type of blood thinner that works by blocking certain proteins in the blood that are involved in clotting. This medication is being evaluated to see how well it helps manage blood clotting after a procedure to close a hole in the heart.

DAPT stands for Dual Antiplatelet Therapy, which involves using two medications that help prevent blood clots by stopping platelets from sticking together. This therapy is being studied to understand its effectiveness in managing blood clotting after heart procedures.

Investigated diseases:

Patent Foramen Ovale – A patent foramen ovale (PFO) is a small opening between the two upper chambers of the heart, the atria, which fails to close naturally after birth. In most people, this opening closes shortly after birth, but in some, it remains open. This condition is usually asymptomatic and often goes unnoticed. However, it can allow blood clots to pass from the right side to the left side of the heart, potentially leading to complications. The presence of a PFO is often discovered incidentally during tests for other conditions. It is a common congenital heart defect, affecting about 25% of the population.

Atrial Septal Defect – An atrial septal defect (ASD) is a hole in the wall (septum) that separates the two upper chambers of the heart, known as the atria. This defect allows oxygen-rich blood to flow from the left atrium into the right atrium, mixing with oxygen-poor blood. Over time, this can lead to increased blood flow to the lungs and overwork the right side of the heart. Symptoms may include shortness of breath, fatigue, and heart palpitations, though some individuals may remain asymptomatic. ASDs are congenital and can vary in size, potentially leading to complications if left untreated. They are often detected during routine medical examinations or imaging tests.

Trial ID:
2024-517115-70-00
Protocol code:
NL79578.100.21
Trial Phase:
Therapeutic exploratory (Phase II)

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