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【ChiCTR2300075841】Relationship between renal function and pharmacogenetics on plasma level of direct oral anticoagulants (DOACs)

基本信息
登记号

ChiCTR2300075841

试验状态

正在进行

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2023-09-18

临床申请受理号

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靶点

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适应症

Atrial fibrillation

试验通俗题目

Relationship between renal function and pharmacogenetics on plasma level of direct oral anticoagulants (DOACs)

试验专业题目

The impact of renal function and pharmacogenetics on plasma level of direct oral anticoagulants (DOACs) in Chinese patients with renal impairment

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

1. Establish the range of peak and trough of DOACs level in Chinese patients 2. Delineate the relationship between plasma DOACs level and renal function in Chinese patients 3. To determine the relationship of plasma direct Xa-inhibitors level and anti-Xa activity (by using LMWH as calibrator) 4. Establish the relationship between bleeding complications and recurrent ischaemic/thromboembolic events and plasma DOACs level 5. Establish the relationship between pharmacogenetic variants and plasma DOACs level as well as the rate of bleeding complications and recurrent ischaemic/thromboembolic events

试验分类
试验类型

横断面

试验分期

其它

随机化

Not applicable as it is not a randomized controlled trial

盲法

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试验项目经费来源

Department support from Department of Pathology, University of Hong Kong

试验范围

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目标入组人数

400

实际入组人数

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第一例入组时间

2022-01-24

试验终止时间

2025-12-31

是否属于一致性

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入选标准

1. Age >= 18 years old 2. Receiving any DOACs (dabigatran, rivaroxaban, apixaban and edoxaban) for atrial fibrillation 3. Follow up in out-patient clinic in Queen Mary Hospital;

排除标准

1. Age <18 years old 2. Patients who are followed up irregularly in out-patient clinic in Queen Mary Hospital 3. Clinical information is incomplete 4. Non-Chinese;

研究者信息
研究负责人姓名
试验机构

Department of Pathology, University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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