NCT06362343招募中不适用
The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Bleeding events
研究概览
简要总结
- Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs).
- Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.
- Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with acute symptomatic pulmonary embolism objectively diagnosed by imaging (with or without deep vein thrombosis) who have completed anticoagulation for the acute phase and have entered the maintenance phase of anticoagulation
- •Expected lifespan greater than 3 months
- •Eligible for the use of Xa factor inhibitors;
- •Agreement to participate in the study, signing of informed consent, and commitment to regular follow-up.
排除标准
- •Moderate or severe liver dysfunction (Child-Pugh grade B or C);
- •Severe renal impairment (CrCl < 15 ml/min);
- •Pregnant or breastfeeding women;
- •Tendency for spontaneous bleeding, such as coagulopathy or thrombocytopenia (PLT < 20×10^9/L);
- •Contraindications for the use of other Xa factor inhibitors;
- •Patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.
研究组 & 干预措施
Patients with pulmonary embolism and using direct oral anticoagulants
Patients with pulmonary embolism and using direct oral anticoagulants
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Bleeding events
时间窗: Through the entire follow-up time, 3 months
Major bleeding events, clinical relatied non-major bleeding events and minor bleeding events
Recurrent thromboembolic events
时间窗: Through the entire follow-up time, 3 months
Recurrent thromboembolic events
次要结局
未报告次要终点
研究者
研究点 (1)
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