Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT06045858
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06045858
Study Brief:
Protocol Section:
NCT06045858