Not recruiting

Study on Rivaroxaban for Patients with Atrial Fibrillation and Coronary Artery Disease After Heart Procedure

Verified siteRegistered drugNo placebo

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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 studying the use of a medication called rivaroxaban in patients who have a heart condition known as atrial fibrillation and have undergone a procedure called percutaneous coronary intervention (PCI). Atrial fibrillation is a common type of irregular heartbeat, and PCI is a procedure used to open blocked blood vessels in the heart. The study will explore the safety and feasibility of using rivaroxaban as the only medication for these patients. Rivaroxaban is available in the form of film-coated tablets, specifically Xarelto 15 mg and Xarelto 20 mg, and is taken orally.

The purpose of this study is to investigate how well rivaroxaban works and how safe it is for patients with atrial fibrillation after they have had PCI. The study will involve 50 patients who will take rivaroxaban for up to 12 months. During this time, researchers will monitor the patients for any health changes, including any potential side effects or complications. The study will also include testing for a specific genetic marker called CYP2C19 genotype, which may affect how patients respond to the medication.

Throughout the study, researchers will keep track of important health outcomes, such as the occurrence of heart attacks, strokes, or any bleeding events. The study aims to provide valuable information on whether rivaroxaban can be safely used as a single treatment for patients with atrial fibrillation who have undergone PCI. This research is expected to be completed by early 2026, with patient recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed based on specific criteria such as being 18 years or older, having undergone a successful percutaneous coronary intervention (PCI), and having a history of or newly diagnosed atrial fibrillation (AF) or atrial flutter with a long-term need for oral anticoagulation (OAC).
Step 2
Medication administration
Participants will receive rivaroxaban as a monotherapy. The medication is provided in the form of film-coated tablets, available in dosages of 15 mg and 20 mg, to be taken orally.
The specific dosage and frequency will be determined by the study protocol and the participant's medical condition.
Step 3
Genotype testing
Participants will undergo CYP2C19 genotype testing. This test helps to understand how the body processes certain medications, which can influence treatment decisions.
Step 4
Monitoring and follow-up
Participants will be monitored for a period of 6 months to assess the primary endpoints. These include the occurrence of any major health events such as all-cause mortality, myocardial infarction, stent thrombosis, or ischemic stroke.
Additionally, any major or clinically relevant non-major bleeding events will be recorded according to established criteria.
Step 5
Completion of the study
The study is expected to conclude by January 1, 2026. Participants will have completed their involvement after the 6-month monitoring period, with all necessary data collected for analysis.

Who can join the trial?

6 criteria

Must be **18 years or older**.
Must have had a **successful PCI**. PCI stands for **Percutaneous Coronary Intervention**, which is a procedure to open up blood vessels in the heart.
Must have a **history of or newly diagnosed AF**. AF stands for **Atrial Fibrillation**, which is a type of irregular heartbeat. This should be diagnosed within **72 hours after PCI/ACS**. ACS stands for **Acute Coronary Syndrome**, which is a term for conditions where the blood supplied to the heart muscle is suddenly blocked.
Must have a long-term (at least **1 year**) need for **OAC**. OAC stands for **Oral Anticoagulation**, which is medication to prevent blood clots.
Must have been treated with a **loading dose of clopidogrel** before or during PCI. Clopidogrel is a medication that helps prevent blood clots.
Both **male and female** participants are eligible.

Who cannot join the trial?

5 criteria

Patients who have a history of **coronary artery disease**. This is a condition where the blood vessels that supply blood to the heart become narrow or blocked.
Patients who have undergone **percutaneous coronary intervention**. This is a procedure used to open blocked or narrowed blood vessels of the heart.
Patients with **atrial fibrillation**. This is a condition where the heart beats in an irregular and often rapid manner.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Rivaroxaban is a medication used in this study to see if it can be safely used on its own in patients who have atrial fibrillation and have undergone a procedure called percutaneous coronary intervention. This medication helps prevent blood clots, which is important for patients with atrial fibrillation, a condition that causes irregular heartbeats and increases the risk of stroke. The study aims to find out if using only rivaroxaban is a safe and effective treatment option for these patients.

Rivaroxaban

What is already known about the treatment

Rivaroxaban – Rivaroxaban is an oral medication taken in tablet form, primarily used to prevent blood clots in patients with conditions like atrial fibrillation, coronary artery disease, and after procedures such as percutaneous coronary intervention. It is currently well-established in medical practice and literature as an anticoagulant. The main therapeutic indication for rivaroxaban is to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. At the molecular level, rivaroxaban works by inhibiting Factor Xa, an essential component in the blood coagulation process, thereby preventing clot formation. It is classified pharmacologically as a direct oral anticoagulant (DOAC).

Investigated diseases

Coronary artery disease
This condition occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, often due to cholesterol-containing deposits (plaque) and inflammation. Over time, the coronary arteries can narrow, reducing blood flow to the heart. This can lead to chest pain (angina), shortness of breath, or other symptoms. If the arteries become completely blocked, it can result in a heart attack. The disease progresses gradually and can be influenced by lifestyle factors and genetics.
Percutaneous coronary intervention
This is a non-surgical procedure used to treat narrowing of the coronary arteries of the heart found in coronary artery disease. During the procedure, a catheter is inserted into the narrowed part of the artery, and a balloon is inflated to open the artery. Often, a stent is placed to keep the artery open. This intervention helps improve blood flow to the heart muscle, relieving symptoms such as chest pain. It is commonly performed to restore blood flow after a heart attack.
Atrial fibrillation
This is an irregular and often rapid heart rate that can increase the risk of strokes, heart failure, and other heart-related complications. It occurs when the heart's two upper chambers (the atria) beat chaotically and irregularly, out of coordination with the two lower chambers (the ventricles). Symptoms often include heart palpitations, shortness of breath, and weakness. The condition can be occasional or persistent and may require medical intervention to manage. It is the most common type of arrhythmia diagnosed in clinical practice.