今天是:2020-07-15 星期三

PPCI术前联合使用evolocumab改善急性心肌梗死患者介入治疗术后短期预后的临床研究
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注册号:

Registration number:

ChiCTR1900024526 

最近更新日期:

Date of Last Refreshed on:

2020-05-31 

注册时间:

Date of Registration:

2019-07-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

PPCI术前联合使用evolocumab改善急性心肌梗死患者介入治疗术后短期预后的临床研究 

Public title:

Effect of perioperative use of PCSK9 inhibitor evolocumab on prognosis of myocardial infarction patients undergoing percutaneous coronary intervention 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

PPCI术前联合使用evolocumab改善急性心肌梗死患者介入治疗术后短期预后的临床研究 

Scientific title:

Effect of perioperative use of PCSK9 inhibitor evolocumab on prognosis of myocardial infarction patients undergoing percutaneous coronary intervention 

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:

张文斌 

研究负责人:

张文斌 

Applicant:

Wenbin Zhang 

Study leader:

Wenbin Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13777572567 

研究负责人电话:

Study leader's telephone:

+86 13777572567 

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:

3313011@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

3313011@zju.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:

浙江省杭州市庆春东路3号 

研究负责人通讯地址:

浙江省杭州市庆春东路3号 

Applicant address:

3 East Qingchun Rd, Hangzhou, Zhejiang 

Study leader's address:

3 East Qingchun Rd, Hangzhou, Zhejiang 

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:

浙江大学医学院附属邵逸夫医院 

Applicant's institution:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University 

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:

keyan20200414-13 and keyan20200522-31 

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:

浙江大学医学院附属邵逸夫医院伦理委员会 

Name of the ethic committee:

Ethics Committee, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-22 

伦理委员会联系人:

刘利民 

Contact Name of the ethic committee:

Limin Liu 

伦理委员会联系地址:

杭州市庆春东路3号 

Contact Address of the ethic committee:

3 East Qingchun Road, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 571-86006811 

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:

浙江大学医学院附属邵逸夫医院 

Primary sponsor:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春东路3号 

Primary sponsor's address:

3 East Qingchun Rd, Hangzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属邵逸夫医院

具体地址:

庆春东路3号

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Address:

3 East Qingchun Road

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

心肌梗死 

Target disease:

myocardial infarction  

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:

其它 

Study phase:

N/A 

研究目的:

本研究的目的是评估围手术期使用PCSK9在心肌梗死患者中的疗效及其安全性。 

Objectives of Study:

The aim of this study is to evaluate the efficacy and safety for perioperative use of PCSK9 in myocardial infarction patients.  

药物成份或治疗方案详述:

对于evolocumab组,在首次PCI术前尽快皮下注射第一剂140mg evolocumab,在第一剂后14天皮下注射第二剂evolocumab。所有患者在随访期间均根据医生判断给予ACS标准化药物治疗,包括但不限于阿托伐他汀20毫克或瑞舒伐他汀10毫克每晚一次,阿司匹林100毫克每日一次,氯吡格雷75毫克每日一次或替格瑞洛90毫克每日两次,血管紧张素转换酶抑制剂或血管紧张素受体拮抗剂(ACEI或ARB),β阻滞剂等。1个月后他汀类药物的使用强度由主治医师根据患者随后的血脂、肝肾功能等情况确定。 

Description for medicine or protocol of treatment in detail:

For evolocumab group, the first dose 140mg evolocumab will be subcutaneously injected as soon as possible before primary PCI and the second dose of evolocumab will be administered 14 days after the first dose. Both groups of patients will be treated with ACS standardized secondary prevention medications at the discretion of the physician, including but not limited to oral atorvastatin 20 mg or rosuvastatin 10 mg per night, aspirin 100 mg once daily, clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily, angiotensin conversion enzyme inhibitor or angiotensin receptor antagonist (ACEI or ARB), β blocker, etc. The intensity of statins after 1 month was determined by the attending physician according to the patient's subsequent lipid profile, as well as liver and renal functions. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

受试者须满足以下所有标准: 1.年龄18-75岁,性别不限。 2.患者入组30天前未使用过他汀类药物。 3.符合心肌梗死诊断标准,包括NSTEMI、STEMI。 NSTEMI、STEMI的诊断标准包括心脏标志物水平至少有1次上升超过正常参考值上限(URL)第99百分位,且符合下列条件中的至少1项: ① 有缺血症状; ② 新出现或很可能新出现ST-T显著改变或新出现左束支传导阻滞(LBBB); ③ 心电图出现病理性Q波; ④ 有存活心肌新损失或新出现局部心壁运动异常的影像学证据; ⑤ 血管造影发现冠状动脉内血栓。 ST段抬高定义为在两个相邻导联的J点处新发的ST段抬高。除V2-V3导联外,所有导联抬高≥0.1mV ,V2-V3导联对<40岁的男性抬高≥0.25 mV,对≥40岁的男性抬高≥0.2 mV,对女性抬高≥0.15mV。ST段压低和T波改变定义为在两个相邻导联上出现新的水平型或下斜型ST段压低≥0.05mV,在两个相邻导联R波为主或R/S>1时T波倒置≥0.1mV。 4.在执行任何方案规定的检查或操作前,签署知情同意书。 

Inclusion criteria

Subjects must meet all the followings: 1. Male and female patients aged 18-75 years old. 2. Patients must be statins-na?ve in the previous 30 days. 3. Meeting the diagnostic criteria for acute MI, including non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI), and receiving coronary intervention therapy within 24 hours of onset. The diagnostic criteria for NSTEMI and STEMI should include cardiac marker levels exceeding the 99th percentile of upper limit of normal reference level (URL) at least once and at least one of the followings: ischemic symptoms; new onset ST-T change or left bundle branch block (LBBB); pathological Q waves; new imaging evidence of local cardiac wall motion abnormality or new loss of viable myocardium; coronary artery thrombosis found by angiography. The ST segment elevation is defined as new ST segment elevation at the J point of two adjacent leads. Except for the V2-V3 leads, all lead elevations should be >= 0.1 mV, and the V2-V3 leads should be elevated >= 0.25 mV for men < 40 years old, >= 0.2 mV for men >= 40 years old, and >= 0.15mV for women. The ST-segment depression and T-wave change are defined as new onset horizontal or down-slope ST-segment depression >= 0.05 mV, or inverted T wave >= 0.1mV when R wave is dominant on two adjacent leads. 4. Signing the informed consent form prior to any inspection or operation as specified in the program. 

排除标准:

1. 患者目前正在服用可能与他汀或PCSK9抑制剂依洛尤单抗(evolocumab)存在相互作用的药物,以及与他汀类药物合用可能会增加横纹肌溶解风险的药物; 2. 患者目前正在服用胆固醇吸收抑制剂(依折麦布)、贝特类、烟酸类及其他降脂药物; 3. 合并有严重肝肾功能不全患者,eGFR<30 mL/min/1.73 m2,AST或ALT≥正常上限3倍; 4. 合并阻塞性黄疽、活动性肝脏疾病、慢性肝炎患者; 5. 合并肌病的患者,肌酸激酶(CK)≥正常上限5倍或不明原因的CK升高或不能耐受降脂治疗者; 6. 妊娠实验阳性,或者未采取避孕措施的育龄期和哺乳期妇女; 7. 合并恶性肿瘤、风湿结缔组织等免疫系统疾病患者; 8. 对他汀或PCSK9抑制剂依洛尤单抗(evolocumab)过敏的患者。 

Exclusion criteria:

1. Currently taking medication that may interact with the statin or PCSK9 inhibitor - evolocumab, and may increase the risk of rhabdomyolysis; 2. Currently taking cholesterol absorption inhibitors (Ezetimibe), fibrates, niacin and other lipid-lowering drugs; 3. Severe liver and renal dysfunction, e.g. estimated glomerulus filtration rate (eGFR) < 30 mL/min/1.73 m2, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3 times URL; 4. Obstructive jaundice, active liver disease, chronic hepatitis; 5. Myopathy, creatine kinase (CK) >= 5 times URL or increased CK with unknown cause or intolerance for lipid-lowering therapy; 6. Patients with a positive pregnancy test, women of childbearing age and lactation who have not used contraception; 7. Malignant tumor, rheumatoid connective tissue disease; 8. Patients who are allergic to statins or the PCSK9 inhibitor - evolocumab. 

研究实施时间:

Study execute time:

From2020-06-01To 2025-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

265

Group:

control group

Sample size:

干预措施:

没有注射PCSK9抑制剂evolocumab

干预措施代码:

Intervention:

without PCSK9 inhibitor evolocumab injected

Intervention code:

组别:

evolocumab组

样本量:

265

Group:

evolocumab group

Sample size:

干预措施:

PCSK9抑制剂evolocumab 140 mg在血运重建前尽快皮下注射一次,第一次注射后14天再注射一次

干预措施代码:

Intervention:

PCSK9 inhibitor evolocumab 140 mg subcutaneously injected once as soon as possible before revascularization + 14 days after the first dose

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

主要不良心血管事件

指标类型:

主要指标 

Outcome:

major adverse cardiovascular events

Type:

Primary indicator 

测量时间点:

1、3、6、12月

测量方法:

包括死亡、再发心梗、再次血运重建、卒中和任何因缺血原因而再住院

Measure time point of outcome:

1, 3, 6 and 12 months

Measure method:

a composite of death, recurrent MI, unanticipated revascularization, stroke and any rehospitalization for ischemic causes

指标中文名:

次要终点

指标类型:

次要指标 

Outcome:

secondary end point

Type:

Secondary indicator 

测量时间点:

1

测量方法:

梗死后心绞痛,是指急性心肌梗死疼痛缓解后1个月内反复发作的心绞痛

Measure time point of outcome:

1 month

Measure method:

post-infarction angina which refers to recurrent angina within 1 month after pain relief in acute MI

指标中文名:

安全终点

指标类型:

副作用指标 

Outcome:

safety end points

Type:

Adverse events 

测量时间点:

1、3、6、12月

测量方法:

包括肌病、肝肾功能受损和其他不良事件

Measure time point of outcome:

1, 3, 6 and 12 months

Measure method:

include myopathy, impaired liver or renal function, and other adverse events

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

导管室的主任可以通过账户密码访问网站进行随机分组,他们不应该参与病人的任何治疗。

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

The directors of catheterization lab can have an access to the website for randomization via account password and they should not participate in any of the patients treatments.

盲法:

开放标签,非盲

Blinding:

open-label

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):

在研究完成后以纸质报告或文章的形式发布

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

Publish after the completion of the study, in the form of paper reports or articles

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:

病例报告表(CRF)由研究者填写,每个入选病例必须完成病例报告表。完成的病例报告表由临床监查员审查后,直接通过EDC系统客户端上传至服务器。研究者不需要填写纸质表格,而是可以通过EDC系统直接录入源数据以完成数据收集工作。研究者对数据的质量负责,需要确保其真实性和完整性。此外,研究者还可以通过EDC系统打印录入完成的病例报告表。

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

The Case Report Form (CRF) is completed by the investigator and each case must be completed. The completed case report form is reviewed by the clinical monitor and uploaded directly to the server via the EDC system client. Researchers do not need to fill out a paper form, but can directly enter the source data through the EDC system to complete the data collection. Researchers are responsible for the quality of the data and their authenticity and integrity. In addition, the investigator can print the completed case report form through the EDC system.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-13
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