【ChiCTR2600121559】急性缺血性轻型卒中早期依替巴肽治疗的前瞻性、多中心、双盲、双模拟随机对照临床试验

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基本信息

登记号

ChiCTR2600121559

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-04-01

临床申请受理号

靶点

适应症

急性缺血性卒中

试验通俗题目

急性缺血性轻型卒中早期依替巴肽治疗的前瞻性、多中心、双盲、双模拟随机对照临床试验

试验专业题目

急性缺血性轻型卒中早期依替巴肽治疗的前瞻性、多中心、双盲、双模拟随机对照临床试验

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联系人邮编

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临床试验信息

试验目的

探讨急性轻型非大血管闭塞的致残性卒中患者早期使用依替巴肽的安全性和有效性。

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

区组随机。由独立第三方（中国人民解放军陆军军医大学军队卫生统计学教研室）采用随机化软件产生随机化数列。

盲法

双盲。

试验项目经费来源

自筹经费

试验范围

目标入组人数

958

实际入组人数

第一例入组时间

2025-06-01

试验终止时间

2028-01-01

是否属于一致性

入选标准

1)年龄≥18周岁； 2)到院时间距离最后正常时间在24小时以内； 3)DSA/CTA/MRA检查非大血管闭塞，不计划进行血管内治疗； 4)发病时的NIHSS评分为＜5分，且存在致残性症状（如孤立性失语、偏盲或肢体无力影响功能）； 5)CT/MRI下ASPSECTS评分>6； 6)患者或家属签署书面知情同意书。；

排除标准

1) Intracranial hemorrhage confirmed by head computed tomography (CT) or magnetic resonance imaging (MRI); 2) Pre-morbid modified Rankin Scale (mRS) score >=2; 3) Pregnant or lactating women; 4) Allergy or allergic predisposition to eptifibatide, contrast agents, aspirin, and clopidogrel, or patients with contraindications to the aforementioned medications; 5) Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with oral antihypertensive medications; 6) Hereditary or acquired hemorrhagic diathesis, deficiency of anticoagulation factors; or patients already on oral anticoagulants with INR >1.7; 7) Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/L (400 mg/dL), platelets <90×10^9/L, hemoglobin <100 g/L, hematocrit <25%; 8) History of bleeding within the past 1 month (hemoptysis, gastrointestinal, urinary tract, or severe systemic bleeding, etc.); 9) Severe hepatic impairment, ALT >3 times upper limit of normal or AST >3 times upper limit of normal; chronic hemodialysis and severe renal impairment (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L (2.5 mg/dL)); 10) Non-atherosclerotic lesions, including: arterial dissection, moyamoya disease, vasculitis, herpes zoster, varicella-zoster or other viral vasculopathy, neurosyphilis, any other intracranial infection, any vascular stenosis associated with cerebrospinal fluid pleocytosis, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign cerebrovascular disease of the central nervous system, postpartum angiopathy, suspected vasospasm, suspected thrombus recanalization; 11) Cardioembolic stroke or potential cardioembolic thromboembolism with any of the following definitive cardioembolic sources: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, left atrial spontaneous echo contrast; 12) History of any brain parenchymal or other intracranial subarachnoid, subdural, or epidural hemorrhage within the past 30 days; 13) Myocardial infarction within the past 30 days; 14) Planned major surgery within 90 days (including open femoral artery, aortic, carotid, subclavian, or intracranial artery bypass grafting, etc.) and cerebral angioplasty (balloon or stent placement); 15) Ejection fraction <40%, dysfunction of vital organs such as heart and lungs; 16) Current severe alcohol dependence or drug abuse; 17) Any terminal illness with expected life expectancy <6 months; 18) Expected inability to complete follow-up; 19) Intracranial aneurysm or arteriovenous malformation; 20) Brain tumor with mass effect on imaging; 21) Currently participating in other clinical trials that may affect study results or previously enrolled in this study; 22) Intravenous thrombolysis.；

研究者信息

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试验机构

重庆医科大学附属第二医院

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