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评价伊伐布雷定联合抗心绞痛单药治疗稳定劳力性心绞痛的疗效和安全性
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注册号:

Registration number:

ChiCTR-TRC-12001878 

最近更新日期:

Date of Last Refreshed on:

2015-07-28 

注册时间:

Date of Registration:

2012-01-09 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

评价伊伐布雷定联合抗心绞痛单药治疗稳定劳力性心绞痛的疗效和安全性 

Public title:

Evaluation of the anti-anginal efficacy and safety of ivabradine used in combination with an anti-anginal monotherapy in patients with stable effort angina pectoris 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价伊伐布雷定联合抗心绞痛单药治疗稳定劳力性心绞痛的疗效和安全性。一项为期6周的随机双盲安慰剂平行对照的国际多中心临床研究。 

Scientific title:

Evaluation of the anti-anginal efficacy and safety of ivabradine used in combination with an anti-anginal monotherapy in patients with stable effort angina pectoris. A 6-week, randomised, double-blind controlled, parallel-group, international, multicentre study. 

研究课题代号(代码):

Study subject ID:

CL3-16257-064 

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:

张艳红 

研究负责人:

高润霖教授 

Applicant:

Linda ZHANG 

Study leader:

Prof. GAO Run Lin 

申请注册联系人电话:

Applicant telephone:

+86 10 65610341-308 

研究负责人电话:

Study leader's telephone:

+86 10 68331622 

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:

linda.zhang@cn.netgrs.com 

研究负责人电子邮件:

Study leader's E-mail:

gaorunlin@263.net 

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:

中国北京市朝阳区东三环中路1号环球金融中心西楼6层 

研究负责人通讯地址:

中国医学科学院阜外心血管病医院心血管研究所,中国北京北礼士路甲167号 

Applicant address:

Unit 2006, 20 Floor, Tower 2, Prosper Center, 5 Guanghua Road, Beijing 

Study leader's address:

Cardiovascular Institute & Fu Wai Hospital, Chinese Academy of Medical Sciences A 167 Beilishi Road, Beijing, 100037 - P.R. China 

申请注册联系人邮政编码:

Applicant postcode:

100020 

研究负责人邮政编码:

Study leader's postcode:

100037 

申请人所在单位:

法国施维雅国际公司北京办事处 

Applicant's institution:

SERVIER INTERNATIONAL BEIJING OFFICE 

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:

082 

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:

阜外心血管病医院伦理委员会 

Name of the ethic committee:

Fuwai Cardiovascular Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-11 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

施维雅国际研究中心 

Primary sponsor:

Institut de Recherches Internationales Servier 

研究实施负责(组长)单位地址:

50, rue Carnot – 92284 Suresnes Cedex - France 

Primary sponsor's address:

Institut de Recherches Internationales Servier 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

施维雅国际研究中心 

Source(s) of funding:

Institut de Recherches Internationales Servier 

研究疾病:

稳定劳力性心绞痛 

Target disease:

Stable effort angina pectoris 

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:

I期临床试验 

Study phase:

研究目的:

本研究的主要目的是验证经6周治疗后,伊伐布雷定(5mg b.i.d.然后7.5mg b.i.d 口服)联合常规抗心绞痛单药对于心绞痛症状的改善优于仅使用常规抗心绞痛单药治疗。 本研究的次要目的是比较伊伐布雷定联合抗心绞痛单药和仅用抗心绞痛单药,经6周治疗后,减慢心率的效果,同时验证伊伐布雷定联合其他抗心绞痛单药治疗的安全性。 

Objectives of Study:

The primary objective of this study was to demonstrate that over a 6-week treatment period, ivabradine (5 mg b.i.d. then 7.5 mg b.i.d. given orally) used in combination with usual anti-anginal monotherapy was more efficient on angina symptomatology than the use of these anti-anginal monotherapies given alone. 

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:

≥18岁的男性、不孕或停经女性;有典型的稳定性劳力型心绞痛病史;无静息性心绞痛或IV级心绞痛(加拿大心血管协会分级,即CCS分级)。患者从未接受过抗心绞痛治疗;或者接受过本研究允许的抗心绞痛单药治疗(非β受体阻滞剂、地尔硫卓、维拉帕米或苄普地尔),且在筛选前该治疗已稳定至少1个月。所有患者在入选访视前的每周平均心绞痛发作次数至少为4次。入选附属ETT研究的患者在入选访视时ETT结果必须阳性(经过阅读中心确认为ETT阳性)。 

Inclusion criteria

Male, sterile or post-menopausal female patients, aged >=18 years old, with a history of typical effort angina pectoris, with clinical stability, no angina at rest and no angina of class IV (according to the CCS Classification). Patients could be either untreated for their angina or treated with an authorised anti-anginal monotherapy (but not a beta-blocker, diltiazem, verapamil, or bepridil) and this treatment was to be stable for at least 1 month prior selection. All patients were to be symptomatic with at least 4 angina attacks/week before the inclusion visit. Patients enrolled in the ETT sub-study were required to have a positive ETT for inclusion in the sub-study (where positivity was confirmed by the central reading centre). 

排除标准:

-(预)筛选访视时有心动过缓症状或ECG示安静状态下心率(HR)<60bpm。 -静息心绞痛、CCS分级判断为IV级心绞痛、不稳定性心绞痛、变异性心绞痛或微血管性心绞痛。 -(预)筛选前3个月内出现过急性心肌梗死。 -(预)筛选前3个月内实施过冠脉冠状动脉旁路血管移植术(CABG)或经皮腔内冠状动脉成型术(PTCA)。 -计划在研究期间行CABG或PTCA者。 -已知严重左主干冠状动脉病变(狭窄≥50%)而未接受旁路血管移植手术或机械装置辅助。 -除冠心病外还存在其他显著的心脏病者(即先天性心脏病,高血压性心脏病,心包疾病,瓣膜病,风湿性疾病或非缺血性心肌病)。 -腹主动脉瘤>5cm或左心室室壁瘤。 -充血性心力衰竭III 或 IV级(NYHA分级)或者未控制的心力衰竭。 -心源性休克。 -严重低血压(收缩压< 90 mmHg)或未控制的高血压: -永久性房颤或在(预)筛选时出现阵发性房颤或房扑。 -安装起搏器或植入式心脏复律除颤器(ICD)。 -接受过抗心绞痛联合用药(除短效硝酸酯类)治疗者。 -存在伊伐布雷定禁忌症。 

Exclusion criteria:

1. Symptomatic bradycardia on (pre-) selection or HR < 60 bpm on (pre-) selection resting ECG; 2. Resting angina or class IV angina of the CCS, unstable angina, Prinzmetal angina or microvascular angina; 3. Acute myocardial infarction < 3 months before (pre-)selection; 4. Coronary artery bypass graft (CABG) less than 3 months before (pre-)selection or percutaneous transluminal coronary angioplasty (PTCA) less than 3 months before (pre-)selection; 5. Procedure of CABG or PTCA scheduled during the time of the study; 6. Known high-grade left main coronary artery disease (equal or greater than 50%) that had not been surgically by-passed or mechanically improved; 7. Clinically significant heart disease other than coronary artery disease (e.g. congenital, hypertensive, pericardial, valvular, rheumatic disease, non-ischaemic cardiomyopathy); 8. Abdominal aorta aneurysm > 5 cm, known left ventricular aneurysm; 9. Congestive heart failure stage III or IV (classification of the NYHA or uncontrolled heart failure); 10. Cardiogenic shock; 11. Severe hypotension (SBP < 90 mmHg) or uncontrolled hypertension: 12. No sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation present at the time of (pre-) selection, flutter; 13. Pacemaker or implanted cardioverter-defibrillator (ICD); 14. Patients previously treated with a combination of anti-anginal treatments (except if the combination involved short acting nitrates); 15. Contra-indication to ivabradine. 

研究实施时间:

Study execute time:

From2008-01-10To 2010-05-31 

干预措施:

Interventions:

组别:

伊伐布雷定

样本量:

216

Group:

Ivabradine

Sample size:

干预措施:

口服伊伐布雷定片剂每日2次5mg 或7,5mg(治疗靶剂量为7.5mg,根据心率和临床标准调整剂量)。

干预措施代码:

Intervention:

Oral ivabradine tablets twice daily 5mg or 7,5mg (target dose: 7.5mg following dose titration based on HR and clinical criteria).

Intervention code:

组别:

安慰剂

样本量:

211

Group:

Placebo

Sample size:

干预措施:

Placebo

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

 

市(区县):

 

Country:

China 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

印度尼西亚 

省(直辖市):

 

市(区县):

 

Country:

Indonesia 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

泰国 

省(直辖市):

 

市(区县):

 

Country:

Thailand 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

国家:

越南 

省(直辖市):

 

市(区县):

 

Country:

Vietnam 

Province:

 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

6周治疗后平均每周心绞痛发作次数较基线的相对变化

指标类型:

主要指标 

Outcome:

Relative change in the mean number of angina attack

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

周治疗后平均每周短效硝酸酯类药物用量较基线的相对变化

指标类型:

主要指标 

Outcome:

Relative change in the mean consumption of short acting nitrates per week over a 6-week treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

次要指标 

Outcome:

Heart rate (HR, bpm)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

加拿大心血管协会(CCS)心绞痛分级

指标类型:

次要指标 

Outcome:

Canadian cardiovascular society (CCS) class

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 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):

研究药物按平衡随机分配,同时按照国家及是否参加附属ETT研究进行分层。

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

Study drug was allocated by balanced central randomisation, non-adaptative, with stratification by c

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

数据管理和编码先由CRO公司北京百汇鹰阁医药技术咨询有限公司负责,最后由施维雅(北京)医药研发有限公司的生物统计部门定稿。

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

Data management and coding of medical data were first carried out by the contract research organisation (CRO) GLENEAGLES CRC (China), and finalised by the Biometry Department of I.R.I.S

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:

施维雅国际研究中心

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

I.R.I.S

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-01-09
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