JPRN-jRCT2080221011已完成2 期
CS-747S clinical pharmacology study
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 133 人开始时间: 2010年2月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
研究概览
简要总结
In patients with non-cardioembolic stroke, who switched from treatment with clopidogrel 75 mg, 4 week CS-747S treatment provided equivalent antiplatelet effects at 2.5 mg and greater effects at 3.75 mg. By CYP2C19 phenotypes, the antiplatelet effects of CS-747S were greater at 3.75 mg in IMs and PMs, and at 2.5 mg in PMs compared with clopidogrel 75 mg. CYP2C19 polymorphisms did not affect the plasma concentration of the active metabolite of CS-747S or its antiplatelet effects, compared to clopidogrel.
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
- •Inclusion criteria
- •At the time of informed consent signature,
- •-The most recent ischemic stroke: 4 weeks or more
- •-Age: Between 20 and 74 years old
- •-Body weight: > 50kg (screening period)
- •-Patients on clopidogrel (75mg/day) for 2 weeks or more
- •(exclude patients with concomitant use of aspirin)
排除标准
- •-Modified Rankin Scale grade 5 or more
- •-Cardiac cerebral embolism, or cardiovascular disease cause of cardiac cerebral embolism (atrial fibrillation, patent foramen ovale, etc.)
- •-Concomitant administration of clopidogrel and aspirin for secondary prevention of ACS etc.
- •-Have active or prior history of intracranial hemorrhage
- •-Have bleeding disorder or bleeding diathesis
研究者
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