Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- measurement of trough plasma levels of DOACs
研究概览
简要总结
Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism
详细描述
Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism. Also the difference between DOACs inducing both CYP3A4 and P-gp transporter (rivaroxaban and apixaban) and DOACs inducing the P-pg transporter only will be investigated. Thriomboembolic and bleeding events during the study duration will be registered and correlated to the measured DOAC plasma levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •patients with a diagnosis of nonvalvular atrial fibrillation or a diagnosis of venous thromboembolism who are taking direct oral anticoagulants according to current guidelines and concomitant enzyme inducers antiepileptic drugs; patients available for a 12 months follow up; patients who can sign informed consent
排除标准
- •patients who stop antiepileptic drugs; age <18 yo patients not willing to perform blood draw or not available for a 12 months follow up; patients who cannot sign informed consent
结局指标
主要结局
measurement of trough plasma levels of DOACs
时间窗: 12 months
measurement of trough plasma levels of DOACs in patients with NVAF and VTE under concomitant therapy with enzyme inducer antiepileptic drugs (EI-AED) and comparison with NVAF and VTE DOAC- treated patients with no EI-AED concomitant therapy
次要结局
- measurement of peak plasma levels of DOACs in patients treated and not treated with EI-EAD(12 months)
研究者
De Candia Erica
Prof.ssa Erica De Candia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS