ChiCTR-TRC-12002688 版本V1.0 版本创建时间2015/11/24 23:33:45 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-TRC-12002688 

最近更新时间:

Date of Last Refreshed on:

2015/5/2 16:15:52 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

银杏酮酯分散片治疗缺血性脑卒中的一项多中心、随机、开放、对照临床研究 

Public title:

Effect of Ginkgo biloba extract dispersible tablets in patients with cerebral ischemic stroke: a multicenter, randomized, open lable, controlled trial 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

银杏酮酯分散片治疗缺血性脑卒中的一项多中心、随机、开放、对照临床研究 

Scientific title:

Effect of Ginkgo biloba extract dispersible tablets in patients with cerebral ischemic stroke: a multicenter, randomized, open lable, controlled trial 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

张雯 

研究负责人:

徐运 

Applicant:

Wen Zhang 

Study leader:

Yun Xu 

申请注册联系人电话:

Applicant telephone:

+86 15105194606 

研究负责人电话:

Study leader's telephone:

+86 25 8310-5208 

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:

zwisxm@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

xuyun20042001@yahoo.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:

中国江苏省南京市北京西路6号 

研究负责人通讯地址:

中国江苏省南京市中山路321号 

Applicant address:

6 Beijing xi Road, Nanjing, Jiangsu, China 

Study leader's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

江苏弘惠医药有限公司 

Applicant's institution:

Jiangsu Honghui Pharmaceutical CO.LTD 

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:

2011051 

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:

南京大学医学院附属鼓楼医院医学伦理委员会 

Name of the ethic committee:

The ethics committee of the Affiliated Drum Tower hospital of Nanjing University 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-07-29 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

南京大学医学院附属鼓楼医院神经内科 

Primary sponsor:

Department of Neurology, Affiliated Drum Tower Hospital of Nanjing University Medical School 

研究实施负责(组长)单位地址:

中国江苏省南京市中山路321号 

Primary sponsor's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京大学医学院附属鼓楼医院

具体地址:

中国江苏省南京市中山路321号

Institution
hospital:

Affiliated Drum Tower Hospital of Nanjing University Medical School

Address:

321 Zhongshan Road, Nanjing, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financiing 

研究疾病:

缺血性脑卒中 

Target disease:

cerebral ischemic stroke 

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:

上市后药物 

Study phase:

研究目的:

评价银杏酮酯分散片联合阿司匹林在缺血性脑卒中治疗和二级预防中的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of Ginkgo biloba extract dispersible tablets plus aspirin in treatment and secondary prevention in patients with cerebral ischemic stroke. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄18-80岁男性或女性; 2.发病72小时内,符合急性缺血性脑卒中的TOAST分型标准,并经神经影像学检查证实; 3.需接受抗血小板药物治疗; 4.入组时改良Rankin量表(modified Rankin scale, mRs)评分0-3分,神经功能缺损评分(NIHSS)评分≥4并<20分; 5.患者为首次发病或既往发病的遗留NIHSS<4分的再次发病者; 6.患者同意接受该方案,并签署知情同意书; 

Inclusion criteria

1.Adult men and women 18-80 years old; 2.Acute ischemic stroke within 72 hours verified by imaging; 3.Have NIH Stroke Scale (NIHSS) score of 4-20 inclusive and modified Rankin scale score of 0-3 inclusive at screening; 4.People who need anti-platelet drugs therapy; 5.First-onset patients or recrudescent patients who NIHSS<4 in past history ; 6.Signed informed consent. 

排除标准:

1.颅内出血或蛛网膜下腔出血史; 2.心源性脑栓塞; 3.严重残疾、严重疾病的终末期; 4.有抗血小板治疗的禁忌症,或在试验期间服用其他抗血小板药物。 5.有较严重的心、肝、肾功能不全,总胆红素>正常值上限的1.5 倍,谷草转氨酶(AST)或谷丙转氨酶(ALT)>正常值上限的2.5 倍; 6.合并有肺部感染,或严重全身感染者; 7.有严重过敏反应史或对2种或2种以上的食物或者药物过敏;及半年内各种免疫接种史; 8.其它脑部器质性病变引起颅高压症状者,如脑肿瘤者; 9.血清HIV阳性,梅毒抗体阳性,乙型肝炎或丙型肝炎患者; 10.严重精神病患者,认知功能障碍,或者不能理解和签署知情同意书的病人; 11.凝血功能障碍者; 12.难以控制的高血压,经治疗血压 ≥180/110mmHg;严重糖尿病(出现晚期并发症),经治疗疾病未能控制;合并有其他影响肢体活动功能的疾病者,治疗前合并有跛行、骨关节炎、类风湿性关节炎、痛风性关节炎等引起的肢体活动功能障碍可能影响神经或功能检查者; 13.3个月内参加过其他临床研究者; 14.经医生判断,还有不适合进行临床研究其他情况存在的患者。 

Exclusion criteria:

1. Have history of intracranial hemorrhage or subarachnoid hemorrhage; 2. Cardiogenic cerebral embolism; 3. Terminal stage of severe disability or illness; 4. Have contraindication of anti-platelet therapy, or use other anti-platelet drug during the trial; 5. Have severe cardiac, hepatic or renal insufficiency. Total bilirubin > 1.5 times of upper normal limit, AST or ALT > 2.5 times of upper normal limit; 6. Have pulmonary infection, or severe systemic infection; 7. Have history of severe allergic reactions, or allergic to drugs or food (≥2 ), or those have immunization history in half a year; 8. Have symptom of intracranial hypertension which induced by organic disease of brain, such as brain tumor; 9. Have serum HIV, TPHA positive, or suffered from hepatitis B or hepatitis C; 10. Have severe mental disorder with cognitive impairment, or not able to understand and sign consent; 11. Have coagulation defects 12. Have uncontrolled hypertension, after treatment the blood pressure≥180/110mmHg; uncontrolled severe diabetes mellitus; Complicate with other diseases which influence activities of limbs such as claudication, osteoarthritis, rheumatoid arthritis or gouty arthritis. 13. Achieved in the prior informed consent within 3 months of participation in other clinical research; 14. Researchers recorgnized anyone who is not suitable to participate in this clinical study of patients. 

研究实施时间:

Study execute time:

From2012-10-23To 2013-10-23 

干预措施:

Interventions:

组别:

治疗组

样本量:

200

Group:

Group A

Sample size:

干预措施:

口服阿司匹林肠溶片,100mg/日,每天1次;口服银杏酮酯分散片,每次0.15g,每日3次

干预措施代码:

Intervention:

Aspirin 100mg orally taken once daily and Ginkgo biloba extract dispersible tablets 0.15g orally three times daily

Intervention code:

组别:

对照组

样本量:

200

Group:

Group B

Sample size:

干预措施:

口服阿司匹林肠溶片,100mg/日,每天1次

干预措施代码:

Intervention:

Aspirin 100mg orally taken once daily

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等医院 

Institution
hospital:

Department of Neurology, Affiliated Drum Tower Hospital of Nanjing University Medical School  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血小板聚集试验

指标类型:

主要指标 

Outcome:

platelet aggregation test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要终点事件及联合终点事件发生率

指标类型:

主要指标 

Outcome:

Occurrence rate of the primary endpoint and combined endpoint

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 18 years
最大 Max age 80 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):

许碧云 随机表随机

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

Biwen Xu Random table

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

注册人:

Name on Registration:

 2012-11-16