The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The perccentage of time that the INR was in the therapeutic range
研究概览
简要总结
To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement.
To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
详细描述
The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •atrial fibrillation
- •atrial fibrillation
- •heart valve replacement
排除标准
- •severe liver or kidney diseases
研究组 & 干预措施
Genetic Group
Dose (mg/week) = [5.6044 - 0.02614 × Age [in years] + 0.0087 × Height [cm] + 0.0128 × Weight [kg] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 *1/*2 - 0.9357 × CYP2C9 *1/*3 - 1.0616 × CYP2C9 *2/*2 - 1.9206 × CYP2C9*2/*3 - 2.3312 × CYP2C9 *3/*3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2
干预措施: CYP2C9;VKORC1 (Genetic)
Control Group
Dose for the first three days after operation will be 4.5mg/d.
结局指标
主要结局
The perccentage of time that the INR was in the therapeutic range
时间窗: 3 months
次要结局
- all drainage fluid of every patient(1 week after operation)