Status:
NOT_YET_RECRUITING
Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)
Lead Sponsor:
University Hospital, Caen
Conditions:
Atrial Fibrillation
Peritoneal Dialysis Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Introduction: Several randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibri...
Detailed Description
The prevalence of AF in the general population is estimated to range around 1% depending on age, reaching 8% in patients over 80 years old. This prevalence is of 20% and 14% in patients on hemodialysi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males and females, age at least 18 years, in ESRD treated with peritoneal dialysis for ≥ 3 months
- Patients with a history of non valvular AF treated by oral anticoagulation or patients initiating oral anticoagulation for a diagnosis of non valvular AF
- CHA2DS2-VASc score of ≥ 2.
- For women of childbearing age who are sexually active, use of an effective method of contraception for up to 10 days after the end of treatment and a negative blood pregnancy test at enrollment.
- Signature of informed consent
- Exclusion criteria
- Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin \<8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
- Moderate or severe mitral stenosis
- Patients with a history of transient ischemic attack or stroke in the 3 months prior to inclusion
- Patient treated with haemodyalisis
- Conditions other than non valvular AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
- Life expectancy \< 3 months
- Anticipated kidney transplant within the next 3 months
- Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, postpartum women, breastfeeding mothers, individuals deprived of their liberty by judicial or administrative decision, minors, individuals under legal protection such as guardianship or trusteeship).
- Women of childbearing age not using a highly effective contraceptive method during the study and up to 10 days after the end of treatment.
- Use of potent inducers of CYP3A4 (particularly rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort (Hypericum perforatum)).
- Use of CYP3A4 and P-gp inhibitors, particularly azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), HIV protease inhibitors, clarithromycin, and erythromycin.
- Contraindication to anticoagulant treatment, such as antiphospholipid syndrome.
Exclusion
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06045858
Start Date
October 30 2024
End Date
October 30 2027
Last Update
August 9 2024
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