EUCTR2007-003746-15-DE进行中（未招募）不适用
prospective randomized open study on the comparison of fondaparinux with the low-molecular-weight heparin enoxaparin in patients undergoing femoro-distal venous bypass operation
Ammerland-Klinik Westerstede0 个研究点开始时间: 2008年2月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •periperal arterial occlusive disease fontaine IIb - IV
- •possibility of venous bypass reconstruction with intended oral antikoagulation
- •women with childbearing potential are only included when using correctly and consistently a highly effective method of birth control (i. e. Pearl-Index less than 1) during the study. As highly effective are regarded:
- •sterilized women
- •vasectomised partner
- •combined oral contraceptives
- •hormone-eluting IUDs
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •progressive renal insufficiency (Creatinine-Clearance < 50 ml/min)
- •known hypersensitivity against Fondaparinux or Enoxaparin
- •known contraindications against either IMP
- •contraindication against oral antikoagulation
- •age < 18 years
- •women of childbearing potential using a method of birth control other than described under E.3
- •known active gastric ulcers
研究者
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