Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial

Phase 1

• Conditions: patients with end-stage renal disease on chronic peritoneal dialysis and with non-valvular atrial fibrillation; MedDRA version: 25.1Level: LLTClassification code: 10008831Term: Chronic ambulatory peritoneal dialysis Class: 10042613; Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

• Registration Number: CTIS2023-507544-37-00
• Lead Sponsor: Centre Hospitalier Universitaire De Caen Normandie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Men and women, aged at least 18 years, with end-stage renal disease (ESRD) treated with peritoneal dialysis for = 3 months., 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, CHA2DS2-VASc score = 2., For women of childbearing age and sexually active, use of an effective method of contraception, Signing of informed consent

Exclusion Criteria

Patients not considered candidates for oral anticoagulation (e.g., hemoglobin < 8.5 g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleeding or retroperitoneal bleeding, severe hepatic impairment, or anaphylactic reaction to apixaban), Patient with history of TIA or stroke in the 3 months preceding inclusion, Patient treated with hemodialysis (hybrid dialysis), Moderate or severe mitral stenosis, Conditions other than non-valvular atrial fibrillation requiring anticoagulation, such as mechanical prosthetic valves, anti-phospholipid syndrome, Life expectancy less than 3 months, Registration on the waiting list for a kidney transplant with a cadaveric donor, Pregnant or breastfeeding woman, Patient under legal protection (Curatelle-Tutelle – Protection of justice)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified