NCT00697151已完成4 期
Patent Foramen Ovale in Cryptogenic Stroke Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Recurrent ischemic stroke and death
研究概览
简要总结
The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-85
- •Ischemic stroke within 30 days
- •Glasgow outcome scale ≥ 3
- •No contraindications to warfarin/aspirin
排除标准
- •Basal INR > 1.4
- •Post-procedural stroke
- •Severe carotid atherosclerosis
- •Cardioembolic stroke
- •Contraindications to transesophageal echocardiography
研究组 & 干预措施
Warfarin
Active Comparator
Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
干预措施: Warfarin (Drug)
Aspirin
Active Comparator
Aspirin 325 mg plus placebo warfarin
干预措施: Aspirin (Drug)
结局指标
主要结局
Recurrent ischemic stroke and death
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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