Comparison of the effects of prophylactic administration of Apixaban on thrombin generation in patients with de novo multiple myeloma and patients undergoing a surgery for total knee replacement: the ProApix Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The primary endpoint is the endogenous thrombin potential (ETP) measured by thrombinography using the MidiCAT method at peak concentration after administration of a 2.5mg dose in patients treated for de novo multiple myeloma (group 1) or operated on for total knee replacement (group 2) with a sample taken 2 hours after the first dose of ‘Apixaban’. ETP is expressed as the concentration of active thrombin multiplied by time (nM.min).
研究概览
简要总结
To compare the pharmacodynamic effect of Apixaban measured by thrombin generation by thrombinography at peak concentration following a 2.5mg dose in patients treated for de novo multiple myeloma (i.e. chemotherapy naïve) (group 1) and in patients operated on for PTG (group 2) in a peripheral venous blood sample taken 2h (32) after Apixaban (H2).
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Blood sampling
- 盲法
- Single (Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age.
- •Signed informed consent.
- •Patient covered by a social security scheme.
- •Group 1 (MM): Patient suffering from de novo multiple myeloma for whom treatment including thromboprophylaxis with apixaban is recommended.
- •Group 2 (PTG): Patient undergoing knee joint replacement with a total prosthesis for whom thromboprophylaxis with apixaban is recommended.
排除标准
- •Indication for curative anticoagulant treatment.
- •Contraindication to the use of apixaban.
- •Pregnant or breast-feeding woman.
- •Refusal to sign the consent form.
- •Protected adult patient.
结局指标
主要结局
The primary endpoint is the endogenous thrombin potential (ETP) measured by thrombinography using the MidiCAT method at peak concentration after administration of a 2.5mg dose in patients treated for de novo multiple myeloma (group 1) or operated on for total knee replacement (group 2) with a sample taken 2 hours after the first dose of ‘Apixaban’. ETP is expressed as the concentration of active thrombin multiplied by time (nM.min).
The primary endpoint is the endogenous thrombin potential (ETP) measured by thrombinography using the MidiCAT method at peak concentration after administration of a 2.5mg dose in patients treated for de novo multiple myeloma (group 1) or operated on for total knee replacement (group 2) with a sample taken 2 hours after the first dose of ‘Apixaban’. ETP is expressed as the concentration of active thrombin multiplied by time (nM.min).
次要结局
- Measurement of Apixaban concentration (in ng/mL) by mass spectrometry during the 12 hours following administration of a dose of Apixaban 2.5mg in both groups.
- Evaluation of the pharmacodynamic evolution kinetics of thrombin generation (using the parameters ETP (nM/min), Lagtime (min), Time to peak (min), Thrombin peak (M Thrombin) in the presence and absence of thrombomodulin in both groups at H0, H2, H6 and H12 of Apixaban administration using the MidiCAT method.
- Modelling of the pharmacokinetic-pharmacodynamic relationship in each group.
- Evaluation of changes in pharmacokinetics (Apixaban dosage in ng/mL) and pharmacodynamics (thrombin generation using the MidiCAT method) after 5 cycles of chemotherapy +/- 1 cycle for patients in group 1.
研究者
project manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne