EUCTR2013-000768-27-HU进行中（未招募）1 期
Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (NAVIGATE ESUS) - Secondary prevention of stroke in patients with ESUS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 7,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Recent ESUS (between 7 days and 6 months), defined as:
- •Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
- •Absence of cervical carotid atherosclerotic stenosis > 50% or occlusion, and
- •No atrial fibrillation after = 24-hour cardiac rhythm monitoring (at least 20 hours acceptable), and
- •No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
- •No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4000
排除标准
- •Severely disabling stroke (modified Rankin score =4)
- •Indication for chronic anticoagulation or antiplatelet therapy
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
研究者
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