NCT01581502Unknown不适用
Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)
Ministry of Health, Labour and Welfare, Japan16 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2011年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 16
- 主要终点
- Ischemic events
研究概览
简要总结
The purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive acute ischemic stroke/TIA patients with NVAF
排除标准
- •Rheumatic mitral valve disease
- •A history of prosthetic valve replacement or mitral valve surgical repair
- •Active infective endocarditis
- •Patient, family member or legally responsible person does not have given informed consent
- •Inappropriate patient's conditions for study enrollment in the opinion of the investigator
结局指标
主要结局
Ischemic events
时间窗: 2 years
Recurrence of ischemic stroke/TIA, ACS, systemic embolism, aortic dissection, rupture of aortic aneurysm, peripheral artery disease (required hospitalization), VTE, revascularization (including CEA/CAS, PCI, etc)
major bleeding
时间窗: 2 years
Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc
次要结局
- modified Rankin Scale(2 years)
- Modification of anticoagulant medication(2 years)
研究者
Kazunori Toyoda
National Cerebral and Cardiovascular Center
Ministry of Health, Labour and Welfare, Japan
研究点 (16)
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