NCT01855737Unknown不适用
Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients
Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose
研究概览
简要总结
- Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients
- Drug: Warfarin
- Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.
- Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.
详细描述
- For the patients who need to use warfarin, detect the "Vitamin K epoxide reductase complex subunit 1 (VKORC1),cytochrome p450 2C9 (CYP2C9), and cytochrome p450 4F2 (CYP4F2) genotype.
- Record the demographic information: gender, age, height, and weight.
- Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results.
- Put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Chinese patients
- •Age >18y
- •target INR 1.5~3.0
- •Patients signed informed consent
排除标准
- •Has hemorrhage disease, or tendency to significant bleeding
- •Severe liver and kidney disfunction, serious infections, severe heart failure (NYHA heart function classification Ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease
- •patients with pregnancy or lactation;
- •with cognitive impairment.
研究组 & 干预措施
Warfarin Using Group
干预措施: Warfarin (Drug)
结局指标
主要结局
The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose
时间窗: one month after the initial dose of warfarin
The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose.
次要结局
未报告次要终点
研究者
Hong Liu
Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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