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Study on the Safety and Effectiveness of Apixaban and Warfarin for Patients with End-Stage Renal Disease on Peritoneal Dialysis and Atrial Fibrillation

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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 two medications, apixaban and warfarin, in patients with a specific heart condition known as non-valvular atrial fibrillation who are also undergoing peritoneal dialysis due to end-stage renal disease. Non-valvular atrial fibrillation is a type of irregular heartbeat that is not caused by a heart valve issue, and peritoneal dialysis is a treatment for kidney failure that uses the lining of the abdomen to filter blood inside the body.

The purpose of the study is to compare the safety of apixaban and warfarin by looking at the occurrence of bleeding events. Participants in the study will be randomly assigned to receive either apixaban or warfarin. The study will last for about a year, during which time participants will take the medication in tablet form by mouth. Throughout the study, researchers will monitor for any major or minor bleeding, as well as other health events like stroke, heart attack, or death from any cause.

Participants will have regular check-ups to assess their health and the effects of the medication. The study aims to provide valuable information on which medication might be safer and more effective for patients with non-valvular atrial fibrillation who are on peritoneal dialysis. This information could help doctors make better treatment decisions for these patients in the future.

The research process

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

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group will receive apixaban, and the other will receive warfarin. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    Participants in the apixaban group will take the medication orally. The dosage and frequency will be determined by the study protocol.

    Participants in the warfarin group will also take the medication orally. The dosage will be adjusted based on regular blood tests to ensure the correct level of medication in the body.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, participants will be monitored for any signs of bleeding, which is a primary concern. This monitoring will continue from the time of randomization until 12 months later.

    Regular check-ups will include assessments for stroke, systemic embolism, myocardial infarction, and overall health status. These assessments will occur periodically over the 12-month period.

  4. Step 4

    Blood tests

    Participants will undergo blood tests to measure INR (International Normalized Ratio) values, which help in adjusting the warfarin dosage. The Rosendaal method will be used for interpretation.

    For those taking apixaban, antiXa activity will be measured at months 1, 6, and 12, and in case of any bleeding events.

  5. Step 5

    Completion of study

    The study is expected to conclude by March 31, 2027. Participants will have completed all required assessments and follow-ups by this date.

Who can join the trial?

6 criteria

  • Men and women who are at least 18 years old.
  • Patients with end-stage renal disease (ESRD), which means the kidneys are not working well, and who have been treated with peritoneal dialysis for 3 months or more. Peritoneal dialysis is a treatment that uses the lining of your belly to filter your blood when your kidneys can't do it.
  • Patients with a history of non-valvular atrial fibrillation, a type of irregular heartbeat, who are either already taking blood-thinning medication or are starting it for this condition.
  • A CHA2DS2-VASc score of 2 or higher. This is a system used by doctors to estimate the risk of stroke in people with atrial fibrillation.
  • Women who can have children and are sexually active must use an effective method of birth control.
  • Signing an informed consent form, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who are not on **chronic peritoneal dialysis**. This is a treatment for kidney failure where a fluid is used to clean the blood inside the body.
  • Patients who do not have **non-valvular atrial fibrillation**. This is a type of irregular heartbeat that is not caused by a heart valve problem.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of a vulnerable population.
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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. In this trial, it is being tested for its safety and effectiveness in patients with non-valvular atrial fibrillation who are undergoing peritoneal dialysis.

  • Warfarin

    is another medication that helps prevent blood clots. It works by decreasing the clotting ability of the blood. This trial is comparing warfarin to apixaban to see which is safer and more effective for patients with non-valvular atrial fibrillation on peritoneal dialysis, particularly focusing on the risk of bleeding.

What is already known about the treatment

  • Apixaban

    Apixaban is an oral medication administered in tablet form, primarily used to prevent blood clots in patients with non-valvular atrial fibrillation, especially those undergoing chronic peritoneal dialysis. It is currently being studied in clinical trials to assess its safety and efficacy compared to warfarin. Apixaban works by inhibiting Factor Xa, an enzyme crucial for blood clot formation, thereby reducing the risk of stroke and systemic embolism. It belongs to the pharmacological class of anticoagulants, specifically direct oral anticoagulants (DOACs).

  • Warfarin

    Warfarin is an oral anticoagulant available in tablet form, widely used to prevent blood clots in patients with conditions like non-valvular atrial fibrillation. It is a well-established medication in medical literature, with ongoing studies comparing its safety to newer anticoagulants like apixaban. Warfarin functions by inhibiting vitamin K-dependent clotting factors, which are essential for blood coagulation. It is classified as a vitamin K antagonist, a traditional class of anticoagulants.

Investigated diseases

  • End-Stage Renal Disease

    This is the final stage of chronic kidney disease where the kidneys can no longer function adequately to meet the body's needs. Patients often require dialysis or a kidney transplant to survive. The disease progresses as kidney function declines over time, leading to the accumulation of waste products and fluid in the body. Symptoms may include fatigue, swelling, and difficulty concentrating. It is often associated with other health issues such as high blood pressure and anemia. Management focuses on slowing progression and addressing complications.

  • Non-Valvular Atrial Fibrillation

    This is a type of irregular heartbeat that is not caused by a heart valve issue. It occurs when the heart's upper chambers beat out of sync with the lower chambers, leading to poor blood flow. The condition can cause symptoms like palpitations, shortness of breath, and fatigue. It may increase the risk of stroke and other heart-related complications. The progression can vary, with some individuals experiencing occasional episodes and others having persistent symptoms. Management typically involves controlling the heart rate and reducing the risk of stroke.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507544-37-00Protocol code23-0164 (APIDP2)Estimated enrolment178 patientsSponsorCentre Hospitalier Universitaire De Caen Normandie

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).