Safety and Efficacy of Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke: a Single-arm, Open-label, Multicenter Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Symptomatic intracranial hemorrhage
研究概览
简要总结
The study is a single-arm, open-label, multicenter clinical trial.The primary purpose of this trial is to evaluate the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke within 48 hours after the use of Eptifibatide injection. Patients with acute ischemic stroke treated with intravascular thrombolytic therapy, mechanical thrombolysis, angioplasty and so on were treated with Eptifibatide injection on the first day, followed by the second day, the third day, the discharge day and the 90 days.
详细描述
The study is a single-arm, open-label, multicenter clinical trial.A total of 220 patients (Age≥18years) with acute ischemic stroke treated with intravascular thrombolysis, mechanical thrombolysis, angioplasty, etc., were treated with Eptifibatide, providing informed consent and medication.The recommended dose of this study was: first, 135ug / kg was injected intravenously or intraductal (within 5 minutes), followed by continuous intravenous infusion of 0.75 ug / kg / min for 24 h. In special cases, it is up to the operator to decide whether to reinject or increase the dosage according to experience. The maximum dose for the first time was 180ug / kg, if necessary, with a 10-minute interval of intravenously or intraductal injection, and a maximum dose of 180ug / kg, intravenously / intraductal injection of no more than 360ug / kg. Continuous intravenous infusion does not exceed 2ug/kg/ Min. Then the second day, the third day, the discharge and 90 days visit. Follow-up information included vital signs and physical examination, observation of symptomatic intracranial hemorrhage, NIHSS scale, and recording of current drug use by AE,SAE.The trial is anticipated to last from January 2019 to December 2019 with 220 subjects recruited form 15 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years.
- •Acute ischemic stroke.
- •Treated with endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, and angioplasty.
- •Written informed consent obtained from patient or patient's legally authorized representative.
排除标准
- •Failed to vascular recanalization (mTICI≤1).
- •Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on.
- •Known coagulopathy, Systemic Bleeding Tendency, or baseline platelet count < 100000/mm
- •History of chronic hepatopathy, liver and kidney dysfunction, elevating ALT (> 3 times normal upper limit), elevating serum creatinine (> 2 times normal upper limit).
- •Patients with severe hypertension (systolic blood pressure > 200mmHg or diastolic blood pressure > 110mmHg).
- •Known drug or food allergy.
- •Used other Glycoprotein IIb/IIIa receptor antagonists.
- •Contraindications for DSA, severe contrast media allergy or iodine contrast media absolute contraindications.
- •Childbearing age women whose pregnancy tests were negative refused to take effective contraception. Pregnant or lactating or positive pregnancy test on admission.
- •Incapable to follow this study for mental illness, cognitive or emotional disorder.
- •The researchers do not consider the participants appropriate to get into this study.
研究组 & 干预措施
Eptifibatide Drug: Eptifibatide Injection
干预措施: Eptifibatide Injection (Drug)
结局指标
主要结局
Symptomatic intracranial hemorrhage
时间窗: Within 48 hours
Incidence of symptomatic Intracranial Hemorrhage within 48 hours after treatment
次要结局
- Cerebral parenchymal hemorrhage type (PH1) and (PH2)(48 hours)
- Total death rate(Within 90 days)
- Serious adverse events(Within 90 days)
- Adverse events(Within 90 days)
- Vascular recanalization(24 hours)
- Favorable clinical outcomes(90 days)
- Neurological recovery(90 days)
- Recurrent ischemic stroke(90 days)
- Combined vascular events(90 days)
研究者
Zhongrong Miao
Chief of Department of Neurological Intervention
Beijing Tiantan Hospital