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

Registration number：

 ChiCTR2300075841 

最近更新日期：

Date of Last Refreshed on：

 2024-02-20 20:05:18 

注册时间：

Date of Registration：

 2023-09-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Dr Sin Chun Fung 

研究负责人：

Dr Sin Chun Fung 

Applicant：

Dr Sin Chun Fung 

Study leader：

Dr Sin Chun Fung 

申请注册联系人电话：

Applicant telephone：

 +852 2255 3173

研究负责人电话：

Study leader's
telephone：

+852 2255 3173

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 scf185@pathology.hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 scf185@pathology.hku.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

T7-043, Block T, Queen Mary Hospital, Pokfulam

研究负责人通讯地址：

T7-043, Block T, Queen Mary Hospital, Pokfulam

Applicant address：

T7-043, Block T, Queen Mary Hospital, Pokfulam

Study leader's address：

T7-043, Block T, Queen Mary Hospital, Pokfulam

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Department of Pathology, School of Clinical Medicine, University of Hong Kong

Applicant's institution：

Department of Pathology, School of Clinical Medicine, University of Hong Kong

研究负责人所在单位：

Department of Pathology, School of Clinical Medicine, University of Hong Kong

Affiliation of the Leader：

Department of Pathology, School of Clinical Medicine, University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 UW 22-086

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-01-20 00:00:00

伦理委员会联系人：

Mr Chris Yip

Contact Name of the ethic committee：

Mr Chris Yip

伦理委员会联系地址：

Rm 90 1, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Contact Address of the ethic committee：

Rm 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 3293

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Pathology, University of Hong Kong

Primary sponsor：

Department of Pathology, University of Hong Kong

研究实施负责（组长）单位地址：

T7-043, Block T, Queen Mary Hospital, Pokfulam Road, Hong Kong

Primary sponsor's address：

T7-043, Block T, Queen Mary Hospital, Pokfulam Road, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong S.A.R

市(区县)：

Country：

China

Province：

Hong Kong S.A.R

City：

单位(医院)：

Department of Medicine, University of Hong Kong

具体地址：

3/F, New Clinical Building, Queen Mary Hospital, Pokfulam Road

Institution
hospital：

Department of Medicine, University of Hong Kong

Address：

3/F, New Clinical Building, Queen Mary Hospital, Pokfulam Road

经费或物资来源：

Department support from Department of Pathology, University of Hong Kong

Source(s) of funding：

Department support from Department of Pathology, University of Hong Kong

研究疾病：

Atrial fibrillation  

Target disease：

Atrial fibrillation

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

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  

Objectives of Study：

1. To establish the range of peak and trough of DOACs level in Chinese patients; 2. To 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. To establish the relationship between bleeding complications and recurrent ischaemic/thromboembolic events and plasma DOACs level; 5. To establish the relationship between pharmacogenetic variants and plasma DOACs level as well as the rate of bleeding complications and recurrent ischaemic/thromboembolic events.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

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

Exclusion criteria：

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

研究实施时间：

Study execute time：

从 From 2022-01-24 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-01 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：

Dabigatran, rivaroxaban, apixaban and edoxaban

样本量：

 400

Group：

Dabigatran, rivaroxaban, apixaban and edoxaban

Sample size：

干预措施：

N/A

干预措施代码：

Intervention：

N/A

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong S.A.R. 

市(区县)：

  

Country：

China

Province：

Hong Kong S.A.R.

City：

单位(医院)：

 Queen Mary Hospital 

单位级别：

 University Hospital 

Institution
hospital：

Queen Mary Hospital

Level of the institution：

University Hospital

测量指标：

Outcomes：

指标中文名：

Plasma DOACs level

指标类型：

主要指标

Outcome：

Plasma DOACs level

Type：

Primary indicator

测量时间点：

At recruitment

测量方法：

Chromogenic anti-Xa assay

Measure time point of outcome：

At recruitment

Measure method：

Chromogenic anti-Xa assay

指标中文名：

Rate of bleeding complications

指标类型：

次要指标

Outcome：

Rate of bleeding complications

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Rate of recurrent ischaemic/thromboembolic events

指标类型：

次要指标

Outcome：

Rate of recurrent ischaemic/thromboembolic events

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Will be destroyed after 15 years of study closure

Fate of sample：

Preservation after use  

Note：

Will be destroyed after 15 years of study closure

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 90 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Not applicable as it is not a randomized controlled trial

Randomization Procedure (please state who generates the random number sequence and by what method)：

Not applicable as it is not a randomized controlled trial.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Not applicable

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not applicable.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data will be collected by study team and also clinician-in-charge of patients. All study data will be coded and anonymised, and kept for 3 years after study closure. Hard copies will be discarded as confidential waste, while soft copies will be deleted and made unrecoverable after completion of the aforesaid storage period. A data collection form is available which outlined all necessary data needed to be collected.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data will be collected by study team and also clinician-in-charge of patients. All study data will be coded and anonymised, and kept for 3 years after study closure. Hard copies will be discarded as confidential waste, while soft copies will be deleted and made unrecoverable after completion of the aforesaid storage period. A data collection form is available which outlined all necessary data needed to be collected.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-09-18 10:04:33
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