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Study on Edoxaban for Patients with Atrial Fibrillation and Coronary Syndrome Undergoing PCI

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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 atrial fibrillation, a condition where the heart beats irregularly, and those experiencing acute coronary syndrome or chronic coronary syndrome, which are types of heart problems. The study is investigating the use of a medication called Lixiana, which contains the active substance edoxaban. This medication is available in two forms: 30 mg and 60 mg film-coated tablets. The purpose of the study is to find the best way to prevent blood clots in these patients, especially after they have undergone a procedure called percutaneous coronary intervention (PCI), which is used to open blocked heart arteries.

Participants in the study will be given either the standard treatment or a new treatment strategy involving Lixiana. The study will compare the safety and effectiveness of these treatments by looking at the risk of bleeding and the occurrence of heart-related events like heart attacks or strokes. The study will last for several weeks, with follow-ups to check on the participants' health and any side effects they might experience.

The trial aims to provide valuable information on how to best manage patients with these heart conditions, ensuring they receive the safest and most effective treatment. The results will help doctors make informed decisions about using Lixiana in patients with atrial fibrillation and heart syndromes, especially after they have had a PCI procedure.

The research process

The trial runs in 4 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, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.
You will undergo an initial assessment to confirm eligibility, which includes being at least 18 years old, having undergone a successful percutaneous coronary intervention (PCI), and having a history of or newly diagnosed atrial fibrillation or flutter.
Step 2
Medication administration
You will be assigned to receive either a 30-day dual antiplatelet therapy (DAPT) or standard therapy. The specific medications and dosages will be explained to you by the study team.
You will take Lixiana tablets, which contain the active substance edoxaban. The dosage will be either 30 mg or 60 mg, taken orally as directed by the study team.
Step 3
Follow-up visits
You will have follow-up visits scheduled at 6 weeks and 6 months after the PCI procedure. These visits are to monitor your health and assess the safety and effectiveness of the treatment.
During these visits, you will be evaluated for any bleeding events and other health outcomes such as heart attack, stroke, or stent-related issues.
Step 4
End of participation
Your participation in the study will conclude after the final follow-up visit at 6 months. The study team will provide you with any necessary information regarding your health and future care.
You will be informed about the overall results of the study once it is completed and analyzed.

Who can join the trial?

4 criteria

Must be 18 years of age or older.
Must have had a successful PCI. (PCI stands for Percutaneous Coronary Intervention, a procedure to open blocked blood vessels in the heart.)
Must have a history of or newly diagnosed atrial fibrillation or flutter. (Atrial fibrillation or flutter is a condition where the heart beats irregularly.)
Must have a long-term need for OAC. (OAC stands for Oral Anticoagulation, which is medication to prevent blood clots.)

Who cannot join the trial?

3 criteria

Patients with **atrial fibrillation** (a condition where the heart beats irregularly) cannot participate.
Patients with **acute coronary syndrome** (a range of conditions associated with sudden, reduced blood flow to the heart) cannot participate.
Patients with **chronic coronary syndrome** (a condition where the heart's blood supply is blocked or reduced over time) cannot participate.

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Verified sites

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Azienda Ospedaliero Universitaria Careggi
Florence, Italy
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Katholieke Universiteit te Leuven
Leuven, Belgium
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Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

Trial locations

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Investigated drugs

DAPT is a therapy that involves taking two medications together to prevent blood clots. This therapy is often used for people who have had a heart procedure called percutaneous coronary intervention (PCI) or who have a condition called atrial fibrillation (AF). The goal of DAPT is to reduce the risk of heart attacks or strokes by keeping the blood flowing smoothly through the arteries.

What is already known about the treatment

Medication Name – This medication is administered orally in the form of tablets and is currently being studied in clinical trials to determine the best antithrombotic strategy for patients with atrial fibrillation who have acute coronary syndrome or are undergoing procedures to open blocked heart arteries. It is primarily used to prevent blood clots in these conditions. The medication works by inhibiting certain proteins in the blood that are responsible for clot formation, thereby reducing the risk of stroke and heart attack. It belongs to a class of drugs known as anticoagulants, which help to keep the blood flowing smoothly in the body.

Investigated diseases

Atrial fibrillation
Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles). This can lead to poor blood flow and may cause symptoms such as heart palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can lead to complications like blood clots and heart failure. The condition can be intermittent or persistent, with episodes that may last from minutes to hours or even longer. It often requires ongoing monitoring to manage its progression.
Acute coronary syndrome
Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It includes situations where the heart muscle is at risk of damage due to insufficient oxygen supply. This condition often presents with chest pain or discomfort, which may radiate to other parts of the body. The progression can lead to more severe heart problems, such as a heart attack, if not addressed promptly. It is typically a result of the buildup of fatty deposits in and on the walls of coronary arteries. The condition requires immediate medical attention to prevent further heart damage.
Chronic coronary syndrome
Chronic coronary syndrome refers to a group of conditions that result from long-term reduction in blood flow to the heart muscle. It is often caused by the gradual buildup of plaque in the coronary arteries, leading to narrowed or blocked arteries. This can cause symptoms like chest pain or discomfort, especially during physical activity or stress. Over time, the reduced blood flow can weaken the heart muscle and lead to heart failure. The condition is typically stable but can become unstable if the plaque ruptures or if a blood clot forms. Management focuses on preventing progression and maintaining heart health.