EUCTR2014-002236-14-DE进行中（未招募）1 期
Phenprocoumon versus Dabigatran in subjects with atrial fibrillation and left atrial thrombus - a prospective, randomized, controlled, open-label one year follow-up pilot study - Thrombus-Reduction
niversity Hospital Ulm0 个研究点目标入组 40 人开始时间: 2015年8月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •- Subjects at an age =18 years both gender
- •- Signed and dated written informed consent
- •- Atrial fibrillation (new, paroxysmal, persistent or permanent)
- •- Left atrial thrombus evaluated by TEE within 7 days prior enrollment
- •- Negative pregnancy test in woman with childbearing potential
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Age = 80 years
- •- Low body weight < 50 kg
- •- Instable cardiac or respiratory condition
- •- Contraindication for Phenprocoumon or Dabigatran (Reference to current SmPC)
- •- Severely reduced renal function (CrCl < 30 ml/min according to Cockcroft-Gault)
- •- Inadequate hepatic function (AST and ALT higher than 2x ULN)
- •- Contraindication for MRI
- •- Pregnant or nursing woman, or sexually active woman of childbearing potential
研究者
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