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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Bethune Beuvry	Beuvry	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Centre Hospitalier De Boulogne Sur Mer	Boulogne sur Mer	France
Ctre Hospitalier Moulins Yzeure	Moulins	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Ibiqpcof Plnmxow Di Nwcgttqqfph	Marseille	France
Exirduscw Cwmnvua Hnprnzulaad Ohksa	Le Mans	France
Ckr doyrbtwbbkrhsp	Epagny Metz Tessy	France
Alwhqznxxk Pwohhuvl Hupmgehj Dn Mfawrwwpc	Marseille	France
Hkyancos Uhfoipgcnlicci Skwvagpffs &ybvbxy Hsjcxmt ds Hcfazvtgnif	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.03.2024

Trial locations

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.

Investigated diseases:

Atrial fibrillation

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 ID:

2023-507544-37-00

Protocol code:

23-0164 (APIDP2)

NCT ID:

NCT06045858

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?