Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Population pharmacokinetic evaluation
研究概览
简要总结
Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :
- to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
- to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.
详细描述
Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :
- to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
- to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with age ≥ 18 years
- •Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion
- •Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation
- •Patients affiliated with a health insurance system
- •Able to provide written informed consent.
排除标准
- •Age <18 years
- •Pregnancy or breastfeeding
- •Patients not affiliated with a health insurance system
- •Patient subject to a measure of protection
- •Legally protected adults
- •Life expectancy < 3 months
结局指标
主要结局
Population pharmacokinetic evaluation
时间窗: 3 years
Estimated area under the curve (AUC) of each of the 2 drugs studied
次要结局
- Safety evaluation(3 years)
研究者
Joe Elie Salem
Clinical Professor, Clinical Investigation Center Paris Est
Groupe Hospitalier Pitie-Salpetriere