JPRN-jRCT2080224080已完成3 期
CS-747S PhaseIII trial - A Double-blind Study of CS-747S Versus Clopidogrel Sulfate in Patients with Thrombotic Stroke Having Risk Factors for Stroke Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 235
研究概览
简要总结
When 3.75 mg of CS-747S or 75/50 mg of clopidogrel sulfate was administered for 24 to 48 weeks, in patients with thrombotic stroke having risk factors for stroke recurrence, the risk ratio of the CS-747S relative to the clopidogrel sulfate group for the primary efficacy endpoint, the incidence of ischemic cardiovascular and cerebrovascular events (a composite of ischemic stroke, myocardial infarction, and death from other vascular cause) was below 1. There were no new safety concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients with evidence of infarct lesion(s) that may have caused the last episode of attack on head imaging
- •-Patients whose subtype of stroke is either large-artery atherosclerosis or small-artery occlusion
- •-Patients with at least one of the following risk factors i. to vi.
- •i.Hypertension: Systolic and diastolic blood pressure of >=140 mmHg and >=90 mmHg.
- •ii.Diabetes mellitus: HbA1c >=6.5%.
- •iii.Chronic kidney disease: Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 or urine protein rated as >=1+.
- •iv.Dyslipidemia: LDL cholesterol >=120 mg/dL, HDL cholesterol <40 mg/dL, and triglyceride >=150 mg/dL.
- •v.If none of the above numerical criteria i. to iv. are met in the presence of pharmacotherapy etc., patients having at least two risk factors from among hypertension, diabetes mellitus, chronic kidney disease, and dyslipidemia are eligible for the study.
- •vi.History of stroke before the last episode of attack
- •-Patients who are able to start treatment with the study drug during the period from 7 days to 26 weeks after onset of the last episode of ischemic attack
排除标准
- •-Patients with symptomatic non-traumatic intracerebral hemorrhage or a known history thereof
- •-Patients with bleeding or a high risk of bleeding
- •-Patients scheduled to undergo cerebral revascularization for the latest ischemic attack
- •-Patients with a severe hepatic disorder
- •-Patients with severe renal disorder requiring dialysis therapy
- •-Patients who have received clopidogrel sulfate for at least 22 days during the period from the last episode of ischemic attack to the start of treatment with the study drug
研究者
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