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Chronic anticoagulation in end-stage renal disease patients: pharmacocinetics and pharmacodynamic of a reduced dose regimen of rivaroxaban (CARD-AXA)
EU CTIS ID: 2023-505733-28-00
What this study is testing
Identify the dose of rivaroxaban (5 mg/day, 10 mg/day or 15 mg/day) with the best biological safety/efficacy profile (pharmacokinetics/phamacodynamics) in a population of chronic haemodialysis patients with no indication for oral anticoagulation
- Therapeutic exploratory (Phase II)
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
- Adult patient ≥ 18 years
- Chronic haemodialysis for at least 3 months
- Participants covered by or entitled to social security
- Patients who have signed a written informed consent form
You likely can't join if
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, persons subject to a legal protection measure: guardianship or trusteeship)
- Severe hepatic insufficiency
- Use of powerful CYP3A4 inducers (in particular rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort (Hypericum perforatum))
- Use of treatments that inhibit CYP3A4 and gp-P, in particular azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, HIV protease inhibitors, clarithromycin and erythromycin).
- Contraindication to anticoagulant treatment, such as anti-phospholipid antibody syndrome
- Contraindications to the administration of rivaroxaban
See the full eligibility criteria
- Adult patient ≥ 18 years
- Chronic haemodialysis for at least 3 months
- Participants covered by or entitled to social security
- Patients who have signed a written informed consent form
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, persons subject to a legal protection measure: guardianship or trusteeship)
- Severe hepatic insufficiency
- Use of powerful CYP3A4 inducers (in particular rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort (Hypericum perforatum))
- Use of treatments that inhibit CYP3A4 and gp-P, in particular azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, HIV protease inhibitors, clarithromycin and erythromycin).
- Contraindication to anticoagulant treatment, such as anti-phospholipid antibody syndrome
- Contraindications to the administration of rivaroxaban
- Patient registered on the renal transplant list and refusing temporary contraindication for the duration of the study
- Patients for whom the investigator considers that they will be unable to undergo the protocol treatment, for whatever reason
- Patient already taking part in an ongoing study or having taken part in a study which ended less than 30 days before the inclusion date
- Women of childbearing age not using a highly effective method of contraception for the duration of the study.
- Any indication for long-term oral anticoagulation (atrial fibrillation, thromboembolic venous disease, mechanical valve prosthesis, intracardiac thrombosis, etc)
- Double anti-platelet aggregation for any reason or a dose of aspirin greater than 160 mg per day
- Uncontrolled arterial hypertension (BP > 180/110 mmHg)
- Ischaemic stroke in the 30 days prior to inclusion
- History of major unprovoked haemorrhage (leading to hospitalisation or transfusion), regardless of how long it has existed
- Surgery in the 30 days prior to inclusion except for interventions considered to have a low risk of bleeding, such as dental care and extractions.
- High-risk bleeding pathology in addition to renal failure, such as a known coagulation disorder, thrombocytopenia (< 100G/L), progressive neoplasia of the digestive or urinary tract, or the presence of an intracranial vascular malformation
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, 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.