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Study on Apixaban for Preventing Stroke in Patients with Atrial Fibrillation and Stage 5 Chronic Kidney Disease

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 the medication Apixaban in patients who have both Atrial Fibrillation and Chronic Kidney Disease stage 5. Atrial Fibrillation is a condition where the heart beats irregularly, and Chronic Kidney Disease stage 5 is the most severe stage of kidney disease, where the kidneys are close to failing or have already failed. The purpose of the study is to see if Apixaban can help prevent strokes in these patients without causing serious bleeding.

Participants in the study will be given Apixaban, which is a type of medication known as an anticoagulant. Anticoagulants help prevent blood clots, which can lead to strokes. The study will compare the effects of taking Apixaban with not taking any anticoagulant medication. Some participants may receive a placebo, which looks like the medication but does not contain any active ingredients. The study will last for a period of up to 72 weeks, during which participants will take the medication orally, meaning they will swallow it in the form of a tablet.

The main goal is to determine if Apixaban can reduce the risk of having an ischemic stroke, which is a type of stroke caused by a blood clot blocking a blood vessel in the brain, or systemic embolism, which is when a blood clot travels to other parts of the body. The study will also monitor for any serious side effects, such as bleeding in the brain or other major bleeding events. Participants will be closely monitored throughout the study to ensure their safety and to gather information on the effectiveness of the treatment.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide a signed written informed consent, either on paper or digitally, to confirm your participation.
You will undergo a series of assessments to confirm your eligibility, including a review of your medical history and a physical examination. Women of childbearing potential will need to take a highly sensitive pregnancy test.
Step 2
Medication administration
If eligible, you will begin taking the study medication, apixaban, which is a film-coated tablet. The dosage is 2.5 mg, taken orally.
You will take the medication twice daily, once in the morning and once in the evening, for the duration of the study.
Step 3
Regular follow-up visits
Throughout the study, you will attend regular follow-up visits. These visits are important to monitor your health and the effects of the medication.
During these visits, you may undergo various tests and assessments, such as blood tests and heart monitoring, to ensure your safety and the effectiveness of the treatment.
Step 4
End of study
At the end of the study, you will have a final visit. This visit will include a comprehensive assessment of your health and a review of your experience during the trial.
You will be provided with information on the next steps and any necessary follow-up care.

Who can join the trial?

6 criteria

Must provide a signed written consent, either on paper or digitally, agreeing to participate in the study.
Must be a man or woman aged 18 years or older.
Must be receiving ongoing treatment with any chronic dialysis or have a very low kidney function, measured as an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² at least twice in the past year, with at least one measurement being less than 15 ml/min/1.73 m² due to chronic kidney disease (CKD).
Must have a diagnosis of atrial fibrillation (AF) or atrial flutter (AFL), which are types of irregular heartbeats.
Must have a CHA2DS2-VASc score of 2 or more for men, or 3 or more for women. This score helps determine the need for blood-thinning medication to prevent stroke.
Women who can become pregnant must have a negative pregnancy test before starting the study and must agree to use effective birth control methods during the study.

Who cannot join the trial?

7 criteria

Patients with **atrial fibrillation** (an irregular and often rapid heart rate) and **Chronic Kidney Disease stage 5** (the most severe stage of kidney disease) cannot participate if they have certain other medical conditions.
Patients who are currently receiving **dialysis treatment** (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) may have specific restrictions.
Patients who have a history of **intracranial bleeding** (bleeding inside the skull) are excluded.
Patients with a high risk of **fatal bleeding** (bleeding that could lead to death) cannot participate.
Patients who are unable to follow the study procedures or take the study medication as directed are not eligible.
Patients who are pregnant or breastfeeding are excluded from the study.
Patients who are participating in another clinical trial at the same time are not allowed to join this study.

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Verified sites

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Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

Trial locations

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Investigated drugs

Apixaban is a medication used to prevent blood clots from forming in the body. In this clinical trial, it is being tested to see if it can help reduce the risk of strokes and other serious complications in patients who have a specific type of irregular heartbeat called atrial fibrillation, especially those who also have severe kidney problems. The goal is to find out if taking Apixaban can lower the chances of having a stroke or a clot without causing too much bleeding, which can be a side effect of blood thinners. This medication is being compared to not using any blood-thinning medication to see which approach is safer and more effective for these patients.

Apixaban

What is already known about the treatment

Apixaban – Apixaban is a medication taken orally, usually in the form of a tablet, and is used to prevent strokes in patients with atrial fibrillation, especially those with severe kidney disease (Chronic Kidney Disease stage 5). It is currently being studied for its effectiveness and safety in these patients, as it may help reduce the risk of stroke and blood clots without causing severe bleeding. Apixaban works by blocking a specific protein in the blood that is involved in clot formation, making it easier for blood to flow smoothly. It belongs to a class of drugs known as anticoagulants, which are often referred to as blood thinners.

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 persistent or occur in episodes that come and go. It often requires ongoing management to control the heart rate and rhythm.
Chronic Kidney Disease Stage 5
Chronic Kidney Disease (CKD) stage 5, also known as end-stage renal disease, is the most advanced stage of chronic kidney disease. At this stage, the kidneys have lost nearly all their ability to function effectively, leading to a significant buildup of waste products and fluid in the body. Symptoms may include fatigue, swelling in the legs and ankles, shortness of breath, and difficulty concentrating. The progression to stage 5 often requires interventions to manage the body's waste products and fluid levels. This stage of CKD can severely impact overall health and quality of life. It typically necessitates ongoing medical care to address the complications associated with kidney failure.