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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Endogenous Thrombin potential (nM.min)
研究概览
简要总结
Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Age ≥ 18 years old,
- •Signed informed consent,
- •Patient covered by a social security scheme.
- •Group 1 : patient with a diagnosis of de novo multiple myeloma, with an indication of thromboprophylaxis with Apixaban,
- •Group 2 : patient requiring a surgery for total knee replacement, , with an indication of thromboprophylaxis with Apixaban.
排除标准
- •Curative doses of anticoagulation treatment,
- •Contra-indication to Apixaban,
- •Pregnant or breastfeeding woman,
- •Refusal to sign consent,
- •Patient under legal protection.
研究组 & 干预措施
Blood sampling of patients undergoing total knee replacement
Description: Blood sampling of patients undergoing total knee replacement
干预措施: Blood sampling (Procedure)
Blood sampling of patients with de novo multiple myeloma
Description: Blood sampling of patients with de novo multiple myeloma
干预措施: Blood sampling (Procedure)
Blood sampling of patients undergoing total knee replacement
Description: Blood sampling of patients undergoing total knee replacement
干预措施: Apixaban (Drug)
Blood sampling of patients with de novo multiple myeloma
Description: Blood sampling of patients with de novo multiple myeloma
干预措施: Apixaban (Drug)
结局指标
主要结局
Endogenous Thrombin potential (nM.min)
时间窗: 2 hours after Apixaban Treatment
Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment
次要结局
- Apixaban concentration (ng/mL)(Kinetics of 12 hours following Apixaban treatment in both groups)
- Pharmacodynamics' kinetics of Endogenous Thrombin Potential(Kinetics of 12 hours following Apixaban treatment in both groups)
- Pharmacodynamics' kinetics of Lagtime(Kinetics of 12 hours following Apixaban treatment in both groups)
- Pharmacodynamics' kinetics of Time to peak(Kinetics of 12 hours following Apixaban treatment in both groups)
- Pharmacodynamics' kinetics of Thrombin peak(Kinetics of 12 hours following Apixaban treatment in both groups)