2023-505733-28-00招募中2 期
Chronic anticoagulation in end-stage renal disease patients: pharmacocinetics and pharmacodynamic of a reduced dose regimen of rivaroxaban (CARD-AXA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area under the AUC curve (drug dosage and anti-Xa activity) for each of the 3 doses of rivaroxaban (5, 10 and 15 mg/d)
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Area under the AUC curve (drug dosage and anti-Xa activity) for each of the 3 doses of rivaroxaban (5, 10 and 15 mg/d)
Area under the AUC curve (drug dosage and anti-Xa activity) for each of the 3 doses of rivaroxaban (5, 10 and 15 mg/d)
次要结局
- Occurrence of bleeding events graded according to the BARC classification during the study period
研究者
Cordinating investigator
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (1)
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