jRCTs031220079已完成不适用
Dual Antiplatelet Therapy for Platelet Aggregation inhibition Effect in Acute Large Artery Atherothrombotic Stroke or High-Risk TIA Patients: Prasugrel versus Clopidogrel (ACUTE-PRAS)
未提供0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Platelet aggregation (PRU) in patients with each genetic polymorphism of CYP2C19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients age are over 20 years at informed consent
- •Patients with acute atherothrombotic cerebral infarction (with a stenosis rate of >= 50% in diameter or complete occlusion of the culprit vessel due to atherosclerosis) with a NIH Stroke Scale score of <= 10 or patients with high-risk TIA (ABCD2 risk score >= 4 or paralyzed)
- •Patients who can receive the study drug within 48 hours after onset of symptoms. The origin of symptom onset is defined as the time point when the normal condition was finally confirmed
- •Patients with at least one of the following risk factors
- •i) Hypertension: patients with a systolic blood pressure of 140 mmHg and a diastolic blood pressure of 90 mmHg or higher, or patients who received therapeutic drugs
- •ii) Diabetes mellitus: HbA1c >= 6.5% or patients who received therapeutic drugs
- •iii) Chronic kidney disease: patients with eGFR < 60 mL/min/1.73 m2 or urinary protein >= 1+
- •iv) Dyslipidemia: LDL cholesterol >= 120 mg/dL, HDL cholesterol < 40 mg/dL, triglyceride >= 150 mg/dL, or therapeutic drugs
- •v) Medical history of cerebral infarction before the onset of index cerebral infarction or TIA
- •Patients from whom written informed consent is obtained after receiving an explanation on the details of this clinical study (consent obtained from patients as long as possible after consent from their legally acceptable representative in urgent situations)
排除标准
- •Patients with a baseline modified Rankin Scale of >= 3
- •Patients who cannot undergo a brain MRI
- •Patients with moderate or high-risk cardiogenic embolic sources in the TOAST classification
- •Patients with or have a medical history of symptomatic nontraumatic intracranial hemorrhage, excludes asymptomatic microbleeding found only on MRI
- •Patients with subarachnoid hemorrhage or with high risk of subarachnoid hemorrhage such as an untreated unruptured cerebral aneurysm of 5 mm or more
- •Patients with cerebral hemorrhage at enrollment which are hemorrhagic infarction, vitreous bleeding, retinal bleeding, blood stasis, hematemesis, bloody urine, bloody stool, melena, hemorrhage, etc., and patients with a high risk of cerebral hemorrhage which are congenital or acquired bleeding diseases, blood coagulation disorders, platelet abnormalities, peptic ulcer etc.
- •Patients who were planned to undergo endovascular thrombectomy or cerebral revascularization, which are carotid endarterectomy, carotid artery stenting etc., for the last cerebral ischemic attack at enrollment
- •Patients who have undergone or were planned to undergo Intravenous rt-PA therapy etc., for the index cerebral infarction at enrollment
- •Patients who scheduled for surgery requiring discontinuation of the study drug during clinical trial
- •Patients who have severe hepatic disorder (fulminant hepatitis, cirrhosis, malignant liver tumors etc.,)
- •Patients who have severe renal disorder requiring dialysis
- •Patients with malignant tumors with requirement for treatment
- •Autoimmune disease
- •Patients who received antiplatelet drugs except for aspirin (such as clopidogrel, prasugrel, cilostazol, ticlopidine or ozagrel sodium) and Anticoagulant (excluding argatroban) within 14 days prior to the initiation of the study treatment
- •Patients who have a medical history of significant side effects or contraindications to prasugrel, clopidogrel or aspirin and patients with a medical history of serious drug allergy (including hypersensitivity to ingredients of this drug)
- •Patients who were pregnant, breastfeeding, or possibly pregnant or planned to be pregnant
- •Patients who are planning to participate in or are participating in other clinical trials during this clinical trial
- •Patients who were judged by the investigator to be ineligible for the study
结局指标
主要结局
Platelet aggregation (PRU) in patients with each genetic polymorphism of CYP2C19
时间窗: 5 days after administration of the study drug
Platelet aggregation (PRU) at 5 days after administration of the study drug in patients with each genetic polymorphism of CYP2C19
Platelet aggregation (PRU) in all patients
时间窗: 5 days after administration of the study drug
Platelet aggregation (PRU) at 5 days after administration of the study drug in all patients
次要结局
- NIHSS score(before administration, at 5 days after administration, at 21 days after administration, or at discharge, whichever comes first)
- Proportion of PRU/Asprin Reaction Unit and high platelete reactivity (PRU > 208) by CYP2C19 genetic polymorphism(predose, at 12 hours to 48 hours postdose, and at 5 days postdose)
- Presence or absence of a new infarction evaluated by MRI diffusion-weighted imaging(before administration, at 5 days after administration)
- Cumulative Incidence of Cerebro and Cardiovascular Events
- Modified Rankin Scale(at 21 days after administration or at discharge, whichever comes first, and 90 days after administration)
- Other Adverse Event Items
- Cumulative Incidence of Bleeding Events
研究者
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