Not recruiting

Study on Dabigatran, Apixaban, Rivaroxaban, and Edoxaban for Patients with Atrial Fibrillation, Deep Vein Thrombosis, or Pulmonary Embolism

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 effects of four different medications on patients with certain heart and blood conditions. The diseases being studied include Atrial Fibrillation (a condition where the heart beats irregularly), Deep Vein Thrombosis (a blood clot in a deep vein, usually in the legs), and Pulmonary Embolism (a blockage in one of the pulmonary arteries in the lungs). The medications being tested are Dabigatran Etexilate, Apixaban, Rivaroxaban, and Edoxaban. These medications are known as non-vitamin K antagonist oral anticoagulants (NOACs), which help prevent blood clots.

The purpose of the study is to compare these four medications to see how safe and effective they are in preventing death and hospitalizations without increasing the risk of major bleeding. The study will involve patients who have been diagnosed with atrial fibrillation, deep vein thrombosis, or pulmonary embolism. Participants will receive one of the four medications or a placebo, and their health will be monitored over time to assess the outcomes.

Throughout the study, participants will take the medication orally, as prescribed, and will be regularly checked by healthcare professionals. The study aims to provide valuable information on whether these medications are equally effective and safe for patients with the specified conditions. The trial is expected to continue until 2027, allowing for comprehensive data collection and analysis.

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, you will be assigned to one of four medications: dabigatran etexilate, apixaban, rivaroxaban, or edoxaban. These medications are taken orally.
The purpose of the study is to compare these medications to see how safe and effective they are in preventing serious health issues without increasing the risk of major bleeding.
Step 2
Medication administration
You will take the assigned medication as prescribed. The dosage and frequency will be determined by the study team based on your specific condition.
It is important to follow the instructions provided for taking the medication to ensure accurate results in the study.
Step 3
Regular check-ups
Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication.
These check-ups are crucial for assessing the safety and effectiveness of the treatment.
Step 4
Reporting symptoms
You will be asked to report any symptoms or side effects you experience while taking the medication.
This information helps the study team understand how the medication affects you and contributes to the overall findings of the study.
Step 5
Completion of the study
The study is expected to continue until August 31, 2027. Your participation will last for the duration specified by the study team.
At the end of your participation, you will have a final check-up to assess your health and gather any remaining data needed for the study.

Who can join the trial?

5 criteria

You must have a diagnosis of atrial fibrillation (a type of irregular heartbeat) or atrial flutter (a similar condition) from an outpatient clinic or after being discharged from the hospital.
You must have a diagnosis of deep vein thrombosis (a blood clot in a deep vein) and/or pulmonary embolism (a blood clot in the lungs) from an outpatient clinic or after being discharged from the hospital.
You must have a prescription for a NOAC (a type of blood thinner medication) from a Danish pharmacy within 14 days of your hospital discharge or outpatient clinic visit.
Both men and women can participate.
Participants should not be from a vulnerable population.

Who cannot join the trial?

3 criteria

Patients with **atrial fibrillation** (a type of irregular heartbeat) or **atrial flutter** (a similar condition) cannot participate.
Patients with **deep vein thrombosis** (a blood clot in a deep vein) cannot participate.
Patients with **pulmonary embolism** (a blockage in a lung artery) cannot participate.

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Verified sites

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Bispebjerg Hospital
Verified
Copenhagen, Denmark

Trial locations

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Investigated drugs

Apixaban
is a medication used to prevent blood clots. It works by blocking certain proteins in your blood that are involved in clotting. This helps reduce the risk of stroke and other complications in people with irregular heartbeats or those who have had blood clots in their veins or lungs.
Dabigatran
is a medicine that helps prevent blood clots by stopping a specific protein in your blood from working. This can help lower the chance of having a stroke or other serious problems if you have an irregular heartbeat or have had blood clots before.
Edoxaban
is a drug that helps prevent blood clots by interfering with the blood's ability to clot. It is used to reduce the risk of stroke and other issues in people with certain heart conditions or those who have experienced blood clots in their veins or lungs.
Rivaroxaban
is a medication that helps prevent blood clots by blocking certain substances in your blood that are needed for clotting. It is used to lower the risk of stroke and other complications in people with irregular heartbeats or those who have had blood clots in their veins or lungs.

What is already known about the treatment

NOACs – NOACs, or Non-vitamin K Antagonist Oral Anticoagulants, are medications taken by mouth to help prevent blood clots. They are currently well-established in medical practice and literature, particularly for conditions like atrial fibrillation, deep vein thrombosis, and pulmonary embolism. These medications work by targeting specific proteins in the blood that are involved in clot formation, effectively reducing the risk of clots without the need for regular blood monitoring. NOACs are classified as anticoagulants and are used to prevent strokes and other complications related to blood clots.

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 like heart palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can lead to complications such as blood clots, which can increase the risk of stroke. The condition can be intermittent or persistent, and its severity can vary among individuals.
Atrial Flutter
Atrial flutter is a type of arrhythmia where the heart's atria beat very fast but in a regular pattern. This rapid beating can cause the heart to pump less efficiently, leading to symptoms such as palpitations, shortness of breath, and dizziness. Atrial flutter can sometimes progress to atrial fibrillation, another type of irregular heartbeat. The condition can be episodic or continuous, and it may lead to complications like blood clots if not managed properly.
Deep Vein Thrombosis
Deep vein thrombosis (DVT) is a condition where a blood clot forms in a deep vein, usually in the legs. This can cause swelling, pain, and redness in the affected area. If a part of the clot breaks off, it can travel through the bloodstream and cause a blockage in the lungs, known as a pulmonary embolism. DVT can occur due to prolonged immobility, injury, or certain medical conditions that affect blood clotting. The condition can be acute or chronic, with varying degrees of severity.
Pulmonary Embolism
Pulmonary embolism is a blockage in one of the pulmonary arteries in the lungs, usually caused by blood clots that travel from the legs or other parts of the body. This can lead to symptoms such as sudden shortness of breath, chest pain, and coughing. The condition can reduce blood flow to the lungs, affecting oxygen levels in the blood. Pulmonary embolism can occur suddenly and requires prompt attention to prevent further complications. It can vary in severity depending on the size and location of the blockage.