JPRN-jRCT2080221542已完成3 期
CS-747S PhaseIII trial -Non-inferiority study of CS-747S versus clopidogrel bisulfate in patients with ischemic cerebrovascular accident.
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 3,753 人开始时间: 2011年8月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,753
研究概览
简要总结
The non-inferiority of CS-747S to clopidogrel for the prevention of ischemic stroke, myocardial infarction, and other vascular death was not confirmed in patients with non-cardioembolic stroke. The incidences rate of cerebro-cardiovascular events and other efficacy events were generally similar to clopidogrel. The incidence rate of adverse events and bleeding events were comparable between CS-747S and clopidogrel, suggesting that there are no significant safety issues with CS-747S.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old(—)
- 性别
- All
入选标准
- •Patients with cerebral infarction that caused the last attack.
- •-The last attack : between 1 and 26 weeks prior to informed consent.
- •-Body weight: over 50 kg
排除标准
- •-Patients who need the dual antiplatelet therapy.
- •-History of intracerebral hemorrhage.
- •-Bleeding disorder or bleeding diathesis.
- •-Patients with poorly-controlled blood pressure.
- •-Severe hepatic disorder or kidney disturbance.
研究者
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