今天是:2019-04-22 星期一

比伐卢定联合替格瑞洛在急性心肌梗死直接经皮冠状动脉介入治疗中的应用研究
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注册号:

Registration number:

ChiCTR1900022529 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

比伐卢定联合替格瑞洛在急性心肌梗死直接经皮冠状动脉介入治疗中的应用研究 

Public title:

Effect of bivalirudin combined with ticagrelor in patients with ST-segment elevation myocardial infarction during primary percutaneous coronary intervention  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

比伐芦定联合替格瑞洛与普通肝素联合替格瑞洛在急性心肌梗死直接PCI治疗患者中有效性与安全性的比较 

Scientific title:

Bivalirudin With Ticagrelor vs Heparin With Ticagrelor During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction 

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:

余晓凡 

研究负责人:

余晓凡 

Applicant:

Xiaofan Yu 

Study leader:

Xiaofan Yu 

申请注册联系人电话:

Applicant telephone:

+86 13365741273 

研究负责人电话:

Study leader's telephone:

+86 13365741273 

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:

501183943@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

501183943@qq.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:

安徽省立医院保健楼7楼心内科合肥市庐阳区庐江路17号  

研究负责人通讯地址:

安徽省立医院保健楼7楼心内科 合肥市庐阳区庐江路17号  

Applicant address:

17 Lujiang Road, Luyang District, Hefei, Anhui, China  

Study leader's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, China  

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:

中国科学技术大学附属第一医院(安徽省立医院)  

Applicant's institution:

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)  

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:

2019-ky03 

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:

安徽省立医院医学研究伦理委员会 

Name of the ethic committee:

Anhui Provincial Hospital Ethics committee for medical research 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-09 

伦理委员会联系人:

陈梅男 

Contact Name of the ethic committee:

Meinan Chen 

伦理委员会联系地址:

安徽省立医院行政楼4楼合肥市庐阳区庐江路17号  

Contact Address of the ethic committee:

17 Lujiang Road, Luyang District, Hefei, Anhui, China  

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:

中国科学技术大学附属第一医院(安徽省立医院) 

Primary sponsor:

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)  

研究实施负责(组长)单位地址:

合肥市庐阳区庐江路17号 

Primary sponsor's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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):

安徽省

市(区县):

合肥市

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

中国科学技术大学附属第一医院(安徽省立医院)

具体地址:

庐阳区庐江路17号

Institution
hospital:

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Address:

17 Lujiang Road, Luyang District

经费或物资来源:

安徽省心血管病研究所开放课题(KF2018007) 

Source(s) of funding:

the open project of Anhui Provincial Cardiovascular Institute (KF2018007)  

研究疾病:

冠心病 

Target disease:

Coronary Artery Disease  

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:

上市后药物 

Study phase:

研究目的:

本研究主要目的是通过观察性研究来比较在替格瑞洛联合阿司匹林抗血小板基础上,直接PCI术中使用比伐芦定对比普通肝素抗凝的疗效和安全性。  

Objectives of Study:

To investigate the efficacy and safety of bivalirudin combined with ticagrelor during primary percutaneous coronary intervention (PPCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)年龄不限,性别不限;包括对于发病48小时内的所有STEMI患者,对于发病超过48小时仍然存在缺血症状,尤其是心电和血流动力学不稳定,并发心源性休克、威胁生命的心律失常等高危患者,持续性ST段抬高或新发生的束支传导阻滞的STEMI患者(2017年ESC急性心梗管理指南建议发病12-48小时或以上的晚期到达的患者虽已无明显症状但有持续性ST段抬高或新发生的左束支传导阻滞以及其它高危因素也可考虑行直接PCI,IIa指征);2) 成功对罪犯血管实施直接PCI术;3) PCI围术期规范应用新型抗血小板药物替格瑞洛;4) 入选患者或其法定监护人被告知研究的性质,理解方案中的规定,并应签署知情同意,同意接受研究药物和临床随访。 

Inclusion criteria

(1)no restrictions on gender and age; patients with symptoms lasting >48 h in the presence of (i) electrocardiogram (ECG) evidence of ongoing ischemia (ST segment elevation of ≥1 mm in two or more contiguous electrocardiogram leads, or with a new left bundle branch block); (ii) ongoing or recurrent pain and dynamic ECG changes; and (iii) ongoing or recurrent pain, symptoms, and signs of heart failure, shock, or malignant arrhythmias; (2) revascularization for culprit target vessel; (3) use of antiplatelet agents (aspirin and ticagrelor, loading or maintenance dose) before PCI as per relevant guidelines;and (4)gave written informed consent. 

排除标准:

1)患者长期或术前5天内服用过氯吡格雷;2)PCI术前4h静脉注射过普通肝素或术前12h内使用过低分子肝素、磺达肝癸钠;3)对肝素,比伐芦定,替格瑞洛过敏或者存在禁忌症;4)合并应用其他抗血小板药物,如西洛他唑等;5)直接PCI前接受过溶栓治疗;6)PCI术前3个月内和术后30天内使用口服抗凝剂(包括:维生素K拮抗剂、新型口服抗凝剂、水蛭素衍生物类)。 

Exclusion criteria:

(1) clopidogrel within 5 days before PCI; (2) use of heparin within 4 hours before PCI/low molecular weight heparin, sodium fondaparinux within 12 hours before PCI; (3) allergy to any of the study drugs; (4) combined with other antiplatelet drugs, (5) intravenous thrombolytic therapy; or (6) warfarin, or new oral anticoagulants within 3 months before PCI or 30 days after PCI. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-07-31 

干预措施:

Interventions:

组别:

1

样本量:

400

Group:

1

Sample size:

干预措施:

比伐芦定联合替格瑞洛

干预措施代码:

Intervention:

Bivalirudin combined with ticagrelor

Intervention code:

组别:

2

样本量:

400

Group:

2

Sample size:

干预措施:

肝素联合替格瑞洛

干预措施代码:

Intervention:

heparin combined with ticagrelor

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽省 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

中国科学技术大学附属第一医院(安徽省立医院) 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of USTC(Anhui Provincial Hospital)  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽省 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

合肥市第一人民医院 

单位级别:

三甲 

Institution
hospital:

The First People's Hospital of Hefei City  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽省 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽医科大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

The Second Hospital of Anhui Medical University  

Level of the institution:

Tertiary A Hospita 

测量指标:

Outcomes:

指标中文名:

net adverse clinical events

指标类型:

主要指标 

Outcome:

净临床不良事件

Type:

Primary 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:

正在进行

Recruiting

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):

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

no

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

等实验结束,数据整理完毕,相关论文发表后公开数据

The way of sharing IPD”(include metadata and pro