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益气通络方干预症状性颅内动脉粥样硬化性狭窄单纯球囊扩张术后再狭窄的临床疗效研究

注册号：

Registration number：

ITMCTR2025000781

最近更新日期：

Date of Last Refreshed on：

2025-04-17

注册时间：

Date of Registration：

2025-04-17

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

益气通络方干预症状性颅内动脉粥样硬化性狭窄单纯球囊扩张术后再狭窄的临床疗效研究

Public title：

Clinical efficacy of Yiqi Tongluo formula in intervening symptomatic atherosclerotic stenosis of intracranial arteries Restenosis after simple balloon dilatation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

益气通络方干预症状性颅内动脉粥样硬化性狭窄单纯球囊扩张术后再狭窄的临床疗效研究

Scientific title：

Clinical efficacy of Yiqi Tongluo formula in intervening Symptomatic Intracranial Atherosclerotic Stenosis restenosis after simple balloon dilatation

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：

B2025043

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：

王革生

研究负责人：

王革生

Applicant：

Gesheng Wang

Study leader：

Gesheng Wang

申请注册联系人电话：

Applicant telephone：

13581759316

研究负责人电话：

Study leader's telephone：

13581759316

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：

wanggesheng@bucm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

wanggesheng@bucm.edu.cn

申请单位网址(自愿提供)：

Study leader's 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：

北京市丰台区方庄芳星园一区6号

研究负责人通讯地址：

北京市丰台区方庄芳星园一区6号

Applicant address：

No.6 Fangxingyuan 1 Fangzhuang Fengtai District Beijing China

Study leader's address：

No.6 Fangxingyuan 1 Fangzhuang Fengtai District Beijing China

申请注册联系人邮政编码：

Applicant postcode：

100078

研究负责人邮政编码：

Study leader's postcode：

100078

申请人所在单位：

北京中医药大学东方医院

Applicant's institution：

Dongfang Hospital Beijing University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

JDF-IRB-2024032102

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

北京中医药大学东方医院临床研究伦理委员会

Name of the ethic committee：

IRB of Dongfang Hospital Beijing University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/10/25 0:00:00

伦理委员会联系人：

夏芸

Contact Name of the ethic committee：

Yun Xia

伦理委员会联系地址：

北京市丰台区方庄芳星园一区6号东方医院东楼南支444

Contact Address of the ethic committee：

444 South Branch East Building Dongfang Hospital No. 6 Fangxingyuan 1 Fangzhuang Fengtai District Beijing China

伦理委员会联系人电话：

Contact phone of the ethic committee：

01067654807

伦理委员会联系人邮箱：

Contact email of the ethic committee：

dfyyec@126.com

研究实施负责（组长）单位：

北京中医药大学东方医院

Primary sponsor：

Dongfang Hospital Beijing University of Chinese Medicine

研究实施负责（组长）单位地址：

北京市丰台区方庄芳星园一区6号

Primary sponsor's address：

No.6 Fangxingyuan 1 Fangzhuang Fengtai District Beijing 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)：

北京市

市(区县)：

丰台区

Country：

China

Province：

Beijing

City：

Fengtai District

单位(医院)：

北京中医药大学东方医院

具体地址：

北京市丰台区方庄芳星园一区6号

Institution
hospital：

ongfang Hospital Beijing University of Chinese Medicine

Address：

No.6 Fangxingyuan 1 Fangzhuang Fengtai District Beijing China

经费或物资来源：

河北省中医药管理局

Source(s) of funding：

Hebei Provincial Administration of Traditional Chinese Medicine

研究疾病：

症状性颅内动脉粥样硬化性狭窄

研究疾病代码：

Target disease：

Symptomatic Intracranial Atherosclerotic Stenosis

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过“单中心随机对照”的临床实验，评价评价益气通络方对单纯球囊扩张术后气虚血瘀证sICAS患者后血管再狭窄的临床疗效与减少sICAS复发性中风方面的安全性和有效性。

Objectives of Study：

A single-center randomized controlled clinical trial was conducted to evaluate the safety and efficacy of Yiqi Tongluo Fang on the clinical efficacy of post-vascular restenosis in patients with qi deficiency and blood stasis after simple balloon dilatation for sICAS as well as on the reduction of recurrent stroke in sICAS.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1）年龄≥18岁； 2) 经抗血小板聚集药物、他汀类药物及控制危险因素等规范内科治疗仍反复发作（近90d内）的缺血性卒中或TIA的sICAS患者； 3) DSA证实责任血管为颅内大动脉（包括颈内动脉颅内段（C5～C7 段）、大脑中动脉水平段（M1 段）、椎动脉硬脑膜内段（V4 段）、基底动脉），病变血管狭窄率≥70%； 4) 采用美国介入和治疗神经放射学学会 / 介入放射学学会侧支循环评估系统评定的侧支循环分级为 0～2 级，脑侧支循环代偿不良，并且脑 CT 灌注成像提示责任血管供血区存在低灌注； 5) 采用高分辨率磁共振血管壁成像，根据血管壁增厚情况和强化方式明确血管狭窄的原因为动脉粥样硬化，且至少有1 种动脉粥样硬化危险因素（如高血压病、糖尿病、高脂血症、高同型半胱氨酸血症或吸烟）； 6) 经《中风病辨证诊断标准》评估后证候诊断具有气虚、血瘀者； 7) 发病前mRS评分评分 0-2 分； 8) 能自愿参加本研究，并已签署知情同意。

Inclusion criteria

1) Age ≥18 years; 2) sICAS patients with recurrent ischemic stroke or TIA (within the last 90 d) despite standardized medical treatment with antiplatelet aggregating drugs statins and control of risk factors; 3) DSA confirmation that the responsible vessel is an intracranial large artery (including the intracranial segment of the internal carotid artery (segments C5-C7) the horizontal segment of the middle cerebral artery (M1) the intradural segment of the vertebral artery ( (including intracranial large carotid arteries (intracranial segment of intracranial carotid artery (C5 to C7) (M1 segment) intradural segment of vertebral artery (V4 segment) basilar artery) and stenosis of ≥70% of the diseased vessels; 4) Poor cerebral collateral circulation compensation with collateral circulation grading of 0-2 using the Collateral Circulation Assessment System (CCAA) of the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology and cerebral CT perfusion imaging suggestive of hypoperfusion in the area of the responsible vascular vessel; 5) High-resolution magnetic resonance angiographic images of the vessel walls to identify stenotic vessels according to the wall thickness and enhancement 5) Atherosclerosis was identified as the cause of stenosis on high-resolution magnetic resonance angiography based on vessel wall thickening and enhancement and at least 1 atherosclerosis risk factor (e.g. hypertension diabetes mellitus hyperlipidemia hyperhomocysteinemia or cigarette smoking). 6) Those who were diagnosed to have qi deficiency or blood stasis by the Criteria for the Identification and Diagnosis of Stroke Diseases. 7) A pre-morbidity mRS score of 0-2. 8) Those who were able to voluntarily participate in this study and signed an informed consent.

排除标准：

1) IS 急性期（发病时间≤24 h）； 2) 预计生命存活＜2年； 3) 合并严重全身系统性疾病或不适合/不耐受双联抗血小板药物治疗、药物无法控制的严重高血压； 4) 颅内动脉非动脉粥样硬化性狭窄如动脉夹层、血管炎、肌纤维发育不良等； 5) 伴发不能提前或同时处理的可能导致患者生命危险的颅内动脉血管畸形，如动脉瘤、动静脉畸形、动静脉瘘等； 6) 有使用阿司匹林、氯吡格雷、肝素、替罗非班、造影剂等的禁忌证； 7) 无症状性狭窄且无法随访；2周内曾发生严重心肌梗死； 8) 除靶血管及其主要供血动脉之外有其他颅内动脉狭窄>70%者； 9) 靶血管的主要供血动脉存在狭窄时，狭窄＞50%需排除，例如：病变部位位于大脑中动脉时，同侧颈内动脉狭窄＞50%需排除；病变部位位于基底动脉时，优势侧椎动脉狭窄＞50%需排除，非责任血管颅外动脉＞70%需排除； 10) 既往3个月内颅内出血，包括脑实质出血、脑室出血、蛛网膜下腔出血、硬膜外出血和硬膜下出血等； 11) 既往靶血管或其主要供血动脉曾行血管成形手术（包括球囊扩张术、支架置入术或内膜剥脱术），或计划行支架置入术者； 12) 血管路径迂曲不能稳定建立血管通路者； 13) 合并严重的心、肝、肾等器官损害患者、怀孕期女性； 14) 伴有精神疾病史、智能障碍者； 15) 正在参加其他临床试验者。

Exclusion criteria：

1) Acute phase of IS (onset ≤ 24 h); 2) Expected survival < 2 years; 3) Severe hypertension that is complicated by severe systemic disease or unsuitable/intolerant of dual antiplatelet therapy or uncontrolled by medications; 4) Non-atherosclerotic stenosis of intracranial arteries such as arterial entrapment vasculitis and myofibrillar dysplasia; 5) Associated intracranial arterial vascular malformations that cannot be managed in advance or at the same time; and life-threatening intracranial arteriovenous malformations such as aneurysms arteriovenous malformations arteriovenous fistulas etc.; 6) contraindications to the use of aspirin clopidogrel heparin tirofiban and contrast media etc.; 7) asymptomatic stenosis that cannot be followed up; a severe myocardial infarction within 2 weeks; 8) intracranial arterial stenosis of > 70% in arteries other than the target vessel and its main supplying arteries; 9) stenosis in the main supplying arteries of the target vessel. 9) Stenosis >50% in the main blood supply artery of the target vessel e.g. >50% stenosis of the ipsilateral internal carotid artery in the middle cerebral artery >50% stenosis of the dominant vertebral artery in the basilar artery and >70% stenosis of the extracranial arteries of the non-responsible vessel. 10) Intracranial hemorrhage in the last 3 months including parenchymal ventricular subarachnoid epidural and epidural hemorrhages and other intracranial hemorrhages. 10) Intracranial hemorrhage within the past 3 months including cerebral parenchymal hemorrhage ventricular hemorrhage subarachnoid hemorrhage epidural hemorrhage and subdural hemorrhage etc.; 11) Previous angioplasty (including balloon dilatation stenting or endothelial debridement) of the target blood vessel or the main arteries of the blood supply or planned to stenting; 12) Those who can not stabilize the establishment of vascular access through tortuous vascular paths; 13) Those who are combined with severe damage to the heart liver kidneys etc. and those who are pregnant; 14) Those who are accompanied by psychiatric diseases mental disabilities 15) Those who are participating in other clinical trials.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2027-12-31

征募观察对象时间：

Recruiting time：

从From 2025-01-01

至To      2027-10-21

干预措施：

Interventions：

组别：

对照组

样本量：

44

Group：

control group

Sample size：

干预措施：

西医常规治疗（双联抗血小板聚集）+益气通络方安慰剂口服

干预措施代码：

Intervention：

Conventional Western medical treatment (dual antiplatelet aggregation) + Yiqi Tongluo formula placebo orally

Intervention code：

组别：

试验组

样本量：

44

Group：

experimental group

Sample size：

干预措施：

西医常规治疗（双联抗血小板聚集）+益气通络方颗粒剂口服

干预措施代码：

Intervention：

Conventional Western medicine treatment (dual antiplatelet aggregation) + Yiqi Tongluo formula granules for oral administration

Intervention code：

样本总量 Total sample size ： 88

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

丰台区

Country：

CHINA

Province：

Beijing

City：

Fengtai District

单位(医院)：

北京中医药大学东方医院

单位级别：

三级甲等

Institution/hospital：

Dongfang Hospital Beijing University of Chinese Medicine

Level of the institution：

Third A

测量指标：

Outcomes：

指标中文名：

血常规、尿常规、便常规、血生化、心电图、生命体征（血压、脉搏、呼吸、心率）、凝血功能、胸部X光

指标类型：

副作用指标

Outcome：

Blood routine、urine routine、stool routine、blood biochemist、electrocardiogramry、Vital signs (blood pressure pulse breathing heart rate)、coagulation function、chest X-ray

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

高敏-C反应蛋白、同型半胱氨酸、高密度脂蛋白、低密度脂蛋白、脂蛋白-B、氧化低密度脂蛋白、甘油三酯、FABP4、血管内皮生长因子、血清基质金属蛋白酶、血清基质金属蛋白酶抑制剂

指标类型：

次要指标

Outcome：

HS-CRP、HCY、 HDL、LDL、Apo-B、Ox-LDL、TG、FABP4、VEGF、TIMP-1、MMP-9

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

mRS评分、NIHSS评分、BI评分

指标类型：

次要指标

Outcome：

mRS、NIHSS、BI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

入组6个月内血管再狭窄发生率

指标类型：

次要指标

Outcome：

Incidence of restenosis within 6 months of enrollment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候积分、中风病诊断与疗效评分、中医证型计分

指标类型：

次要指标

Outcome：

Chinese Medicine Evidence Score, Stroke Diagnosis and Efficacy Score, Chinese Medicine Evidence Scoring

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

入组3个月、6个月内靶血管供血区以外的任何卒中（出血性/缺血性卒中）

指标类型：

次要指标

Outcome：

Any stroke (hemorrhagic/ischemic stroke) outside of the target vessel's blood supply area within 3 months and 6 months of enrollment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

入组3个月、6个月的责任血管局部血流动力学及全脑灌注的改善情况

指标类型：

次要指标

Outcome：

Improvement of local hemodynamics and whole brain perfusion in the responsible vessel at 3 and 6 months of enrollment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

责任血管再狭窄率

指标类型：

主要指标

Outcome：

Responsible vascular restenosis rate

Type：

Primary indicator

测量时间点：

术后第 1-2 天，术后第6个月±7天

测量方法：

狭窄率=(1-最窄处的管径/病变远端正常的管径)× 100%或狭窄率=(1-最窄处的管径/病变近端正常的管径)×100%

Measure time point of outcome：

Postoperative day 1-2, postoperative month 6 ± 7 days

Measure method：

Stenosis rate = (1 - diameter at narrowest point / normal diameter distal to lesion) × 100% or Stenosis rate = (1 - diameter at narrowest point / normal diameter proximal to lesion) × 100%

指标中文名：

入组3个月、6个月内靶血管供血区任何卒中（出血性/ 缺血性卒中）或死亡发生率

指标类型：

次要指标

Outcome：

Incidence of any stroke (hemorrhagic/ischemic stroke) or death in the target-vessel-supplying area within 3 and 6 months of enrollment

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：

标本中文名：

粪便

组织：

Sample Name：

Stool

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

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：

标本中文名：

尿液

组织：

Sample Name：

Urine

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 100 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用多中心、随机、双盲、平行对照研究方法。按照中心分层区组随机化法运用SAS8.2版统计软件编辑产生，按各中心预期病例数进行分配。研究用药根据随机分配表进行编码，受试者严格按照研究用药物编号的顺序入组。

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

Multicenter randomized double-blind parallel controlled study method was used in this study. Randomization was generated according to the center-stratified block group randomization method using SAS version 8.2 statistical software editing and allocation was done according to the expected number of cases in each center. The study drugs were coded according to the randomized allocation table and subjects were enrolled strictly in the order of the study drug numbers.

盲法：

双盲（对受试者和研究者均隐藏分组）

Blinding：

Double blind (hidden grouping for both subject and investigator)

是否共享原始数据：

IPD sharing：

否

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）：

无

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

NO

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：

数据录入：采取双人双录入方式，录入至课题组专用数据库（EDC）中，每次录入完成后进 行数据检查，以防录入错误。 数据核查与管理：研究病例是临床试验受试者的源文件(source document)，应保存于医院；研究病例记录要求:1.研究者必须在诊治受试者同时书写研究病例，保证数据记录 及时、 完整、准确、真实。2.研究病例做任何有证据的更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。3.化验结果均需填写至研究病例的“理化检查结果报告表 ”； 研究病例的审核:每一受试者观察疗程结束后，研究者应在 3个工作日内 将“研究病历”、“知情同意书 ”、“患者用药记录卡 ”交本单位主要研究者审核、签名; 一周内，交项目负责人复审并存入基地资料档案室，发现问题及时处理并记录； 数据存档：数据存档采用纸质材料、电子数据库存储相结合的存储方式。 病例报告表(CRF)的填写与移交:完成的病例报告表由临床研究者和监查员审查后， 由课题协作单位负责数据填写，由数据统计单位进行数据管理工作。所有 过程均需方案记录。 数据的录入与修改:数据录入由课题协作单位负责。为保证数据的准确性， 应由两个 数据管理员独立进行双份录入并校对。对病例报告表中存在的疑问。数据管理员将填写疑问解答表(DRO)，并通过临床监查员向研究者发出询问，研究者应尽快解答并返回，数据管理员根据研究者的回答进行数据修改，确认与录入，必要时可以再次发出 DRO。 数据库的锁定:在盲态审核并确认所建的数据库无误后，由主要研究者、统计分析人员对数据库进行锁定。锁定后的数据文件原则上不可再做改动。如数据库锁定之后发现的问题，经确认后可在统计分析过程中进行修正，并作记录和说明。 数据溯源：课题病例样本资料均进行存档，编号，并交由专人负责保管，以确保数据来源真实、可靠。

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

Data Entry: Adopt the double entry method enter into the special database (EDC) of the subject group and check the data after each entry to prevent entry errors. Data verification and management: the research case is the source document of the clinical trial subjects which should be kept in the hospital; the research case record requirements: 1. The researcher must write the research case at the same time of diagnosis and treatment of the subjects to ensure that the data record is timely complete accurate and true. 2. The research case can only be underlined when making any corrections with evidence and the corrected data should be annotated and signed and dated by the researcher. Signed and dated by the researcher no erasure or covering of the original record. 3. Laboratory results should be filled in to the Physical and Chemical Examination Results Report Form of the study case; Review of study cases: After the completion of the observation course for each subject the investigator shall submit the study medical record informed consent and patient medication record card to the principal investigator of the unit for review and approval within 3 working days. Within 3 working days the researcher should submit the Research Medical Record Informed Consent and Patient Medication Record Card to the principal investigator of the organization for review and signature; within one week the researcher should submit them to the project leader for review and deposit them in the base archive room; Data archiving: data archiving using a combination of paper materials electronic database storage storage method. Case report form (CRF) filling and transfer: the completed case report form by the clinical researcher and the supervisor after review by the collaborative unit is responsible for filling in the data by the data statistics unit for data management. All processes should be documented by the program. Data entry and modification: Data entry is the responsibility of the collaborating organization. In order to ensure the accuracy of the data the two data managers should independently carry out double entry and proofreading. Questions on the case report form will be answered by the data manager. The data manager will fill out a question answer form (DRO) and send a query to the investigator through the clinical supervisor. The investigator should answer the query as soon as possible and return it to the data manager who will then modify the data according to the investigator's answer validate and enter the data and if necessary send another DRO. Locking of the database:After the blinded audit and confirmation of the accuracy of the database created the principal investigator and statistical analyst will lock the database. In principle no further changes can be made to the data files after locking. If problems are found after the database is locked they can be corrected during the statistical analysis after confirmation and records and explanations will be made. Data Traceability: The sample data of the subject cases are archived numbered and handed over to a special person for safekeeping to ensure that the source of data is true and reliable.

数据管理委员会：

Data Managemen Committee：

无

No

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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