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Clinical trial about the prophylactic effects of supplementing Qi and hemastasis formula on gastrointestinal bleeding after percutaneous coronary intervention in patients at high bleeding risks
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注册号:

Registration number:

ChiCTR1800014485 

最近更新日期:

Date of Last Refreshed on:

2018-01-16 

注册时间:

Date of Registration:

2018-01-16 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中药益气止血方预防出血高危患者PCI术后消化道出血的临床研究 

Public title:

Clinical trial about the prophylactic effects of supplementing Qi and hemastasis formula on gastrointestinal bleeding after percutaneous coronary intervention in patients at high bleeding risks 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中药益气止血方预防出血高危患者PCI术后消化道出血的临床研究 

Scientific title:

Clinical trial about the prophylactic effects of supplementing Qi and hemastasis formula on gastrointestinal bleeding after percutaneous coronary intervention in patients at high bleeding risks 

研究课题代号(代码):

Study subject ID:

No:Z151100004015085 

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:

张辰浩 

研究负责人:

张辰浩 

Applicant:

Chenhao Zhang 

Study leader:

Chenhao Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13671393316 

研究负责人电话:

Study leader's telephone:

+86 13671393316 

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:

zhangch500@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangch500@126.com 

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:

中国中医科学院望京医院急诊科,北京,中国 

研究负责人通讯地址:

中国中医科学院望京医院急诊科,北京,中国 

Applicant address:

Emergency department, Wangjing hospital, China Academy of Chinese Medical Sciences, Beijing, China 

Study leader's address:

Emergency department, Wangjing hospital, China Academy of Chinese Medical Sciences, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100102 

研究负责人邮政编码:

Study leader's postcode:

100102 

申请人所在单位:

中国中医科学院望京医院 

Applicant's institution:

Wangjing hospital, China Academy of Chinese Medical Sciences 

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:

WJEC-KT-2015-006-P002 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国中医科学院望京医院医学伦理委员会 

Name of the ethic committee:

Medical ethic committee of Wangjing hospital, China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

程爱华 

Contact Name of the ethic committee:

Aihua Cheng 

伦理委员会联系地址:

北京市朝阳区花家地街中国中医科学院望京医院 

Contact Address of the ethic committee:

Wangjing hospital, China Academy of Chinese Medical Sciences 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

中国中医科学院望京医院 

Primary sponsor:

Wangjing hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市朝阳区花家地街望京医院 

Primary sponsor's address:

Wangjing hospital, Huajiadi Street, Chaoyang District, Beijing, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

具体地址:

北京市朝阳区花家地街望京医院

Institution
hospital:

Wangjing hospital, China Academy of Chinese Medical Sciences

Address:

Wangjing hospital, Huajiadi Street, Chaoyang District, Beijing, China

经费或物资来源:

北京市科技计划课题-首都临床特色应用研究与成果推广 

Source(s) of funding:

Capital featured projects of Beijing municipal science and technology commission (No:Z151100004015085) 

研究疾病:

冠心病 

Target disease:

coronary heart disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过随机、双盲、平行对照研究,评估中药益气止血方对PCI术后消化道出血的预防作用,从而寻找出既不增加心血管事件发生率同时又能有效防止消化道出血的临床治疗方案。 

Objectives of Study:

To evaluate the clinical efficacy of traditional Chinese medicine (TCM) Supplementing Qi and hemostasis formula on gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI), and thus find out the optimal therapeutic regimen to reduce incidence of GI bleeding without increase of major adverse cardiovascular events (MACEs). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)符合冠心病诊断标准; (2)成功行PCI术; (3)CRUSADE 评分≥41; (4)签署知情同意书。 

Inclusion criteria

1) Meet the diagnostic criteria of CHD; 2) Underwent PCI operation successfully; 3) CRUSADE score ≥41; 4) Be able to sign informed consent. 

排除标准:

(1)2周内服用华法林或其他抗血小板药物 (2)血小板计数<100×109/L (3)贫血 血红蛋白<100g/L (4)消化性溃疡活动期 (5)1个月内使用PPI (6)出血倾向或血液病 (7)妊娠或哺乳期 (8)对试验药物任一成分过敏 (9)1个月内参加过其他临床试验 

Exclusion criteria:

1) Use of Warfarin or other agents that might affect platelet aggregation within two weeks; 2) Platelet number <100×10^9/L; 3) Anemia, hemoglobin <100g/L; 4) Active peptic ulcer; 5) Use of PPI within one month; 6) Bleeding tendency or hematological disorders; 7) Pregnant and lactating female; 8) Allergic to component of the test drugs and allergic constitution; 9) Participated to other clinical trial within one month. 

研究实施时间:

Study execute time:

From2015-03-01To 2018-09-01 

征募观察对象时间:

Recruiting time:

From2016-05-01To 2017-05-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

130

Group:

treatment arm

Sample size:

干预措施:

中药益气活血方+常规治疗

干预措施代码:

Intervention:

supplementing qi and hemostasis fomula + routine treatment

Intervention code:

组别:

对照

样本量:

65

Group:

Control

Sample size:

干预措施:

泮托拉唑钠肠溶胶囊+常规治疗

干预措施代码:

Intervention:

Pantoprazole Sodium Enteric-Coated Capsules + routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院望京医院 

单位级别:

三级甲等医院 

Institution
hospital:

Wangjing hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

主要心血管事件

指标类型:

主要指标 

Outcome:

Incidence of MACE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出血事件发生率

指标类型:

主要指标 

Outcome:

Bleeding events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状评分

指标类型:

次要指标 

Outcome:

TCM syndrome score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血栓弹力图

指标类型:

次要指标 

Outcome:

Thromboelastogram

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

采用平行区组随机化方法,借助SAS 9.2统计软件PROC PLAN过程语句,给定种子数,分别产生124例受试者所接受处理的随机数字表,设定区组长度为4,按1:1比例将患者分为试验组和对照组。

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

Randomization was generated using random permuted blocks. SAS 9.2 software PROC PLAN was applied to generate random number table for 124 patients included with the block length setting as 4. Patients were then randomized in a 1:1 fashion into two arms (treatment arm and control arm).

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

2019.04 http://www.chictr.org.cn/index.aspx

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

2019.04 http://www.chictr.org.cn/index.aspx

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:

中药益气止血方预防出血高危患者PCI术后消化道出血的临床研究

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

CRF:Clinical trial about the prophylactic effects of supplementing Qi and hemastasis formula on gastrointestinal bleeding after percutaneous coronary intervention in patients at high bleeding risks.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-16
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