Apixaban for End-stage renal disease (on chronic peritoneal dialysis) | Non-valvular atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Men and women, aged at least 18 years, with end-stage renal disease (ESRD) treated with peritoneal dialysis for ≥ 3 months.\n- Patients with a history of non-valvular atrial fibrillation treated with oral anticoagulation or patients starting oral anticoagulation for a diagnosis of non-valvular atrial fibrillation\n- CHA2DS2-VASc score ≥ 2.\n- For women of childbearing age and sexually active, use of an effective method of contraception\n- Signing of informed consent\n- Affiliation to a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Patients not considered candidates for oral anticoagulation (active bleeding, recent gastrointestinal bleeding, severe hepatic impairment)\n- History of anaphylactic reaction to apixaban\n- Use of millepertuis (potent CYP3A4 inducer).\n- - Use of powerful inhibitors of CYP3A4 and gp-P: o azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, miconazole - systemic route and oral gel) o HIV protease inhibitors.\n- Taking acetylsalicylic acid in doses of 500 mg per dose to 3 g per day\n- Patient with history of TIA or stroke in the 3 months preceding inclusion\n- Patient treated with hemodialysis (hybrid dialysis)\n- Moderate or severe mitral stenosis\n- Conditions other than non-valvular atrial fibrillation requiring anticoagulation, such as mechanical prosthetic valves, anti-phospholipid syndrome\n- Life expectancy less than 3 months\n- Registration on the waiting list for a kidney transplant with a cadaveric donor\n- Pregnant or breastfeeding woman\n- Patient under legal protection (Curatelle-Tutelle – Protection of justice)"}

Primary endpoints

• {"endpoint_text":"- Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).","definition_or_measurement_approach":"Assessment period from randomization to Month 12. Primary measurement: ISTH score; secondary bleeding classifications: GUSTO and TIMI."}

Secondary endpoints

• {"endpoint_text":"- Stroke or systemic embolism [Period: From randomization until Month 12].","definition_or_measurement_approach":"Assessed from randomization until Month 12; event incidence (stroke or systemic embolism)."}
• {"endpoint_text":"- Myocardial infarction [Period: From randomization until Month 12].","definition_or_measurement_approach":"Assessed from randomization until Month 12; event incidence (myocardial infarction)."}
• {"endpoint_text":"- Death from any cause [Period: From randomization until Month 12].","definition_or_measurement_approach":"All-cause mortality assessed from randomization until Month 12."}
• {"endpoint_text":"- INR values, interpretation by Rosendaal method","definition_or_measurement_approach":"INR values collected and interpreted using the Rosendaal method."}
• {"endpoint_text":"- antiXa activity of apixaban at M1, M6, M12, and in case of bleeding.","definition_or_measurement_approach":"Anti-Xa activity measurements for apixaban at Month 1, Month 6, Month 12 and at bleeding events."}

France

Latest Decision Or Authorization Date

12-09-2025

Number Of Sites

20

Number Of Participants

178

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France