Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS
研究概览
简要总结
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation. Special coagulation tests like hemoclot for dabigatran and chromogenic substrate assays for Rivaroxaban, Apixaban, and Edoxaban are time-consuming and can be performed only in specialized laboratories. In specific medical situations like in patients such as emergency procedures, stroke (before starting thrombolytic therapy), trauma, general surgery or other invasive procedures, it may be necessary for medical decision making to know the presence or absence of a DOAC in patient's body fluid. Until now there is no rapid, specific and sensitive coagulation test available in the market.
详细描述
This prospective, open-label, controlled, not randomized trial in healthy volunteers to investigate comparatively the pharmacokinetics of the direct oral anticoagulants in plasma and in urine with LC-MS/MS and in urine by DOAC Dipstick.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Fully signed and dated written informed consent
- •Age >18 years
排除标准
- •Patients not able to provide urine samples.
- •Patients not able to understand the informed consent or severe mentally disabled.
- •Patients in the end-stage of a severe disease.
研究组 & 干预措施
Apixaban
Volunteers receive one oral dose of 5mg Apxiaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.
Biological and clinical safety parameters are measured.
干预措施: Apixaban 5 MG Tab (Drug)
Dabigatran
Volunteers receive one oral dose of 150mg Dabigatran followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.
Biological and clinical safety parameters are measured.
干预措施: Dabigatran 150 MG Tab (Drug)
Edoxaban
Volunteers receive one oral dose of 60mg Edoxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.
Biological and clinical safety parameters are measured.
干预措施: Edoxaban 60Mg Tab (Drug)
Rivaroxaban
Volunteers receive one oral dose of 20mg Rivaroxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.
Biological and clinical safety parameters are measured.
干预措施: Rivaroxaban 20 MG Tab (Drug)
结局指标
主要结局
Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS
时间窗: up to 6 months
Assess the accuracy and specificity of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients True positive and true negative rate of the point of care test (POCT) by comparison with the results obtained by bioanalytical quantification
次要结局
- Comparison of qualitative POCT with quantitative LC-MS/MS(up to 6 months)
- Questionnaire on handling and usability(up to 6 months)
研究者
Job Harenberg
Clinical Professor
Heidelberg University