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Study on the Safety and Effectiveness of Warfarin for Patients with Atrial Fibrillation Undergoing Dialysis

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 safety and effectiveness of a medication called Warfarin in patients who have both atrial fibrillation and end-stage renal disease. Atrial fibrillation is a condition where the heart beats irregularly, and end-stage renal disease is the last stage of chronic kidney disease where the kidneys can no longer function on their own. Patients with these conditions often require dialysis, a treatment that helps to filter and clean the blood using a machine.

The purpose of this study is to understand how well Warfarin, a medication that helps prevent blood clots, works in patients who are on dialysis and have atrial fibrillation. The study will compare patients taking Warfarin with those who are not receiving any treatment to see if there are differences in the occurrence of events like strokes or transient ischemic attacks, which are often referred to as mini-strokes. The study will also look at the risk of major bleeding, which can occur in different parts of the body, such as the brain or stomach.

Participants in the study will be randomly assigned to either receive Warfarin or no treatment. The study will be conducted over a period of time, and researchers will monitor the health of the participants to gather information on the safety and effectiveness of the medication. This information will help doctors understand the best ways to treat patients with atrial fibrillation who are also undergoing dialysis.

The research process

The trial runs in 6 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 be assessed to ensure you meet the eligibility criteria, which include being 18 years or older, on chronic dialysis due to end-stage renal disease, and having a specific type of irregular heartbeat called atrial fibrillation.
Step 2
Initial assessment
An initial health assessment will be conducted. This may include a review of your medical history and a physical examination.
You may undergo tests such as an electrocardiogram (ECG) to confirm the diagnosis of atrial fibrillation.
Step 3
Medication administration
If you are selected to receive treatment, you will be given Warfarin Teva 2.5 mg Tablets to take orally.
The dosage and frequency of the medication will be determined by the study team and will be explained to you in detail.
Step 4
Regular monitoring
Throughout the trial, you will have regular appointments to monitor your health and the effects of the medication.
These appointments may include blood tests and other assessments to ensure your safety and the effectiveness of the treatment.
Step 5
Reporting symptoms
You will be asked to report any symptoms or side effects you experience during the trial.
This information is important for assessing the safety of the medication.
Step 6
Completion of the trial
At the end of the trial, a final assessment will be conducted to evaluate your health and the outcomes of the treatment.
You will be informed about the results of the study and any further steps if necessary.

Who can join the trial?

5 criteria

Must be at least 18 years old.
Must be on chronic dialysis due to end-stage renal disease. Dialysis is a treatment that does some of the things done by healthy kidneys.
Must have a new diagnosis of non-valvular atrial fibrillation or have had it for more than 2 months without treatment. Atrial fibrillation is a type of irregular heartbeat.
The atrial fibrillation must be documented by an electrocardiogram (ECG), which is a test that records the electrical activity of the heart, or by a recording of an episode lasting at least 30 seconds on a Holter monitor (a portable device for continuously monitoring the heart), or episodes lasting at least 6 minutes on other recording devices.
Both men and women can participate.

Who cannot join the trial?

2 criteria

Patients with **end-stage renal disease** cannot participate. This means the kidneys are no longer able to work as they should to meet the body's needs.
Patients with **atrial fibrillation** cannot participate. This is a condition where the heart beats in an irregular and often rapid manner.

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Verified sites

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Aalborg University Hospital
Verified
Aalborg, Denmark
Herlev Hospital
Verified
Herlev, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Warfarin is a medication used to prevent blood clots. It is often prescribed for people with atrial fibrillation, a condition where the heart beats irregularly. In this clinical trial, warfarin is being tested to see how safe and effective it is for patients who are on dialysis, which is a treatment for kidney failure. The goal is to find out if warfarin can help prevent strokes and other complications in these patients without causing too many side effects.

Warfarin Sodium

What is already known about the treatment

Warfarin – Warfarin is a medication administered orally, typically in the form of a tablet, and is used to prevent blood clots. It is currently well-established in medical practice and literature, particularly for its role in managing conditions like atrial fibrillation and preventing complications in patients with end-stage renal disease on dialysis. The main therapeutic indication for warfarin is to reduce the risk of stroke and blood clots in patients with irregular heartbeats or those undergoing dialysis. At the molecular level, warfarin works by inhibiting the action of vitamin K, which is necessary for the formation of clotting factors in the blood, thus thinning the blood and preventing clots. It is classified as an anticoagulant, commonly known as a blood thinner.

Investigated diseases

End-stage renal disease
This condition occurs when the kidneys are no longer able to function at a level needed for day-to-day life. It is the final stage of chronic kidney disease, where the kidneys have lost about 90% of their ability to work. As the disease progresses, waste products and fluids build up in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. Patients may experience a decrease in urine output and changes in skin color. The progression of the disease can lead to complications like high blood pressure, anemia, and bone disease. Without kidney function, the body cannot maintain a balance of fluids, electrolytes, and waste products.
Atrial fibrillation
This is a common heart rhythm disorder 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). As the condition progresses, it can lead to symptoms such as palpitations, shortness of breath, and fatigue. The irregular heart rhythm can cause blood to pool in the atria, increasing the risk of blood clots. Over time, atrial fibrillation can weaken the heart and lead to heart failure. The condition may be persistent or come and go, with episodes lasting from minutes to hours.