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Antiplatelet therapy for prevention of atherosclerosis in chronic kidney disease: A perspective, multi-center randomized controlled trial
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注册号:

Registration number:

ChiCTR1900021393 

最近更新日期:

Date of Last Refreshed on:

2019-02-24 

注册时间:

Date of Registration:

2019-02-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

抗血小板预防CKD动脉粥样硬化的临床多中心RCT研究 

Public title:

Antiplatelet therapy for prevention of atherosclerosis in chronic kidney disease: A perspective, multi-center randomized controlled trial 

注册题目简写:

抗血小板治疗CKD 

English Acronym:

ATLAS Study 

研究课题的正式科学名称:

抗血小板预防CKD动脉粥样硬化:一项多中心,随机,对照研究 

Scientific title:

Antiplatelet prophylaxis for atherosclerosis in chronic kidney disease: a multicenter, randomized, pacebo-controlled trial 

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:

熊加川 

研究负责人:

赵景宏 

Applicant:

Xiong Jiachuan 

Study leader:

Zhao Jinghong 

申请注册联系人电话:

Applicant telephone:

+86 18696784882 

研究负责人电话:

Study leader's telephone:

+86 13668007369 

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:

petter_xiong@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaojh@tmmu.edu.cn 

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:

重庆市沙坪坝区新桥正解183号新桥医院第三住院部肾内科 

研究负责人通讯地址:

重庆市沙坪坝区新桥正解183号新桥医院第三住院部肾内科 

Applicant address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

Study leader's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400037 

研究负责人邮政编码:

Study leader's postcode:

400037 

申请人所在单位:

陆军军医大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of the Amy Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

陆军军医大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of the Amy Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区新桥正解183号新桥医院第三住院部肾内科 

Primary sponsor's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川省人民医院

具体地址:

青羊区一环路西二段32号

Institution
hospital:

Sichuan Provincial People's Hospital

Address:

32 Second Section of First Ring Road West, Qingyang District

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

同济大学附属同济医院

具体地址:

新村路389号

Institution
hospital:

Tongji Hospital of Tongji University

Address:

389 Xincun Road

国家:

中国

省(直辖市):

贵州

市(区县):

贵阳

Country:

China

Province:

Guizhou

City:

单位(医院):

贵州省人民医院

具体地址:

中山东路52号

Institution
hospital:

Guizhou Provincial People’s Hospital

Address:

52 Zhongshan Road East

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市中医院

具体地址:

江北区盘溪七支路6号

Institution
hospital:

Chongqing Traditional Chinese Medicine Hospital

Address:

6 Seventh branch of Panxi Road, Jiangbei District

经费或物资来源:

陆军军医大学临床医学科研人才培养计划 

Source(s) of funding:

The training program for clinical medical research of the army military medical university 

研究疾病:

慢性肾脏病 

Target disease:

chronic kidney diseases  

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:

IV期临床试验 

Study phase:

研究目的:

评价抗血小板治疗对CKD加速性AS的抑制作用; 评价抗血小板治疗是否能降低CKD患者心血管事件或死亡率; 评价CKD患者抗血小板治疗的安全性。 

Objectives of Study:

1. To evaluate the inhibitory effect of antiplatelet therapy on accelerated AS in CKD; 2. To evaluate whether antiplatelet therapy reduces cardiovascular events or mortality in CKD patients; 3. To evaluate the safety of antiplatelet therapy in CKD patients. 

药物成份或治疗方案详述:

⑴ 试验组用药:阿司匹林给药方案:每日剂量100mg,1次/日,口服给药,口服给药,不受饮食限制;如发现漏服,应立即补充给药,次日仍按原方案服药;若阿司匹林不耐受,可换用氢氯吡格雷给药方案:每日剂量75mg,1次/日,口服给药,不受饮食限制;如发现漏服,应立即补充给药,次日仍按原方案服药。 ⑵ 空白对照:对照组继续合并用药,不使用阿司匹林或氢氯吡格雷。 

Description for medicine or protocol of treatment in detail:

(1) aspirin group: daily dose of 100mg, once a day, oral administration, oral administration, without dietary restrictions;If it is found that the medicine is missed, it shall be supplemented immediately, and the medicine shall be taken the next day according to the original plan; if aspirion can not be tolerated,then swicht to hydroclopidogrel, a daily dose of 75mg, once a day, oral administration, without dietary restrictions;If it is found that the medicine is missed, it shall be supplemented immediately, and the medicine shall be taken the next day according to the original plan. ⑵ The control group:the control group continued to use the drug combination without aspirin or hydroclopidogrel. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

⑴ 符合CKD的诊断,根据K/DOQI指南:①肾损害≥3个月,伴有或不伴有肾小球滤过率(GFR)的降低。肾损害是指肾脏结构或功能异常,表现为下列之一:有病理学检查异常;或有肾损害指标,包括血、尿成分异常,或影像学检查异常,②eGFR<60ml/min/1.73m2≥3个月,有或无肾损害。肾小球滤过率采有CKD-EPI联合Cystatin C 公式:eGFR=169×Scr-0.608×CysC-0.63×Age-0.157×(0.83 if female); ⑵ 诊断为CKD3期-CKD5期(非透析)患者,年龄14-65周岁(包括14岁和65岁),性别、民族不限; ⑶ 经过颈部血管超声明确无颈部血管斑块,无动脉粥样硬化; ⑷ 患者签署知情同意书。 

Inclusion criteria

1. renal impairment 3 months, with or without decreased glomerular filtration rate (GFR). Renal damage refers to the abnormal structure or function of the kidney, manifested as one of the following: 1) pathological examination abnormalities; 2) eGFR<60ml/min/1.73m2 3 months, with or without renal damage.EGFR =169 Scr-0.608 CysC-0.63 Age-0.157 (0.83 if female); 2. For patients with CKD stage 3-5 (non-dialysis), age 14-65 years old (including 14 and 65 years old), gender, ethnicity is not limited; 3. The ultrasound of the cervical blood vessels showed no cervical vascular plaque and no atherosclerosis. 4. patients signed informed consent. 

排除标准:

⑴ 无法提供知情同意; ⑵ 无法或不愿完成研究所需要的流程; ⑶ 正在参与其他干预性临床试验; ⑷ 妊娠期或哺乳期妇女; ⑸ 既往诊断CKD时合并有心血管疾病或既往有心血管疾病的患者,明确诊断心肌梗塞、心力衰竭、脑出血等严重心脑血管合并症; ⑹ NYHA III级或IV级心力衰竭,即有基础心脏疾病,体力活动明显受限,小于一般体力活动甚至休息状态下即可出现疲乏、心悸、气喘或心绞痛症状; ⑺ 肝硬化; ⑻ HIV感染或艾滋病; ⑼ 既往2年内因恶性肿瘤接受化疗或烷化剂治疗; ⑽ 肾移植患者; ⑾ 入组前存在深静脉血栓栓塞症; ⑿ 入组前已经长期服用阿司匹林或氢氯吡格雷,或近三个月内短暂使用过阿司匹林或氢氯吡格雷; ⒀ 有活动性性出血或凝血功能异常患者。 

Exclusion criteria:

1. unable or unwilling to complete the required process for the research; 2. participating in other interventional clinical trials; 3. women who are pregnant or lactating; 4. previous diagnosis of CKD with cardiovascular disease or previous cardiovascular disease patients, it shall clearly diagnosis myocardial infarction, heart failure, cerebral hemorrhage and other serious cardiovascular and cerebrovascular complications; 5. NYHA level III or IV heart failure, that is, there is a basic heart disease, physical activity was significantly limited, less than the general physical activity or rest state may appear fatigue, palpitations, asthma or angina symptoms; 6. Lilitide cirrhosis; 7. Therefore HIV infection or AIDS; 8. In the past 2 years due to malignant tumor chemotherapy or alkylation agent treatment; 9. kidney transplant patients; 10. on the existence of deep venous thromboembolism before inclusion; 11. In the prior to entering the group, in the long-term use of aspirin or hydroclopidogrel, or in the recent three months in the short use of aspirin or hydroclopidogrel; 12. the patients with active bleeding or coagulation dysfunction. 

研究实施时间:

Study execute time:

From2019-04-01To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2019-04-01To 2019-09-30 

干预措施:

Interventions:

组别:

1

样本量:

277

Group:

Group 1

Sample size:

干预措施:

阿司匹林

干预措施代码:

Intervention:

Aspirin

Intervention code:

组别:

2

样本量:

277

Group:

Group 2

Sample size:

干预措施:

空白对照

干预措施代码:

Intervention:

Blank control

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

the Second affiliated hospital ofArmy Medical University (Xinqiao Hospital)  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Provincial People’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

同济大学附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital of Tongji University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

贵州 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guizhou Provincial People’s Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市中医院 

单位级别:

三级甲等 

Institution
hospital:

Chongqing Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

动脉粥样硬化

指标类型:

主要指标 

Outcome:

Atherosclerosis

Type:

Primary indicator 

测量时间点:

基线,随访第六6个月,第12个月,第24个月,第36个月

测量方法:

颈部血管彩超

Measure time point of outcome:

Baseline, sixth month, 12th month, 24th month, 36th month

Measure method:

ultrasound

指标中文名:

复合心血管事件

指标类型:

次要指标 

Outcome:

Complex cardiovascular events

Type:

Secondary indicator 

测量时间点:

基线,随访第六6个月,第12个月,第24个月,第36个月

测量方法:

① 急性ST 抬高性心肌梗死;② 其他急性冠脉综合症;③ 需住院治疗的充血性心力衰竭;④ 严重心律失常。

Measure time point of outcome:

Baseline, sixth month, 12th month, 24th month, 36th month

Measure method:

(1) acute st-elevation myocardial infarction;(2) other acute coronary syndrome;(3) congestive heart failure requiring hospitalization;(4) serious arrhythmia.

指标中文名:

全因死亡

指标类型:

次要指标 

Outcome:

all-cause mortality

Type:

Secondary indicator 

测量时间点:

第36个月

测量方法:

死亡记录登记表

Measure time point of outcome:

the 36th month

Measure method:

Death record

指标中文名:

eGFR下降50%

指标类型:

次要指标 

Outcome:

A 50% drop in eGFR

Type:

Secondary indicator 

测量时间点:

第36个月

测量方法:

肾功能检测

Measure time point of outcome:

the 36th month

Measure method:

Renal function test

指标中文名:

出血

指标类型:

副作用指标 

Outcome:

bleeding

Type:

Adverse events 

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:

血清

组织:

Sample Name:

serum

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 14 years
最大 Max age 65 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):

中心随机分组

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

center randomization

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

不公开

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

private

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-02-18
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