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Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial
EU CTIS ID: 2023-507544-37-00
What this study is testing
To compare the safety of apixaban versus warfarin, comparing the incidence of the endpoint Bleeding
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Affiliation to a social security scheme
You likely can't join if
- Patients not considered candidates for oral anticoagulation (active bleeding, recent gastrointestinal bleeding, severe hepatic impairment)
- History of anaphylactic reaction to apixaban
- Use of millepertuis (potent CYP3A4 inducer).
- - 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.
- Taking acetylsalicylic acid in doses of 500 mg per dose to 3 g per day
- Patient with history of TIA or stroke in the 3 months preceding inclusion
See the full eligibility 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
- Affiliation to a social security scheme
- Patients not considered candidates for oral anticoagulation (active bleeding, recent gastrointestinal bleeding, severe hepatic impairment)
- History of anaphylactic reaction to apixaban
- Use of millepertuis (potent CYP3A4 inducer).
- - 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.
- Taking acetylsalicylic acid in doses of 500 mg per dose to 3 g per day
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.