跳至主要内容
临床试验/EUCTR2007-004578-15-NL
EUCTR2007-004578-15-NL进行中(未招募)不适用

A randomised, double blind placebo controlled trial to (A) assess the optimal vitamin K dosage for supplementation, and (B) to access whether complications of anticoagulation treatment will diminish by supplementation of vitamin K: VIKS-2A / VIKS-2B. - VIKS-2A / VIKS-2B

Dutch Heart Foundation0 个研究点目标入组 2,600 人开始时间: 2007年11月29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
入组人数
2,600

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

  • 1. Start treatment with vitamin K antagonists less then 4 weeks before inclusion.
  • 2. Treatment with vitamin K antagonists for a minimal period of 6 months, with the therapeutic range of INR between 2.5 and 3.5.
  • 3. Age between 18 and 85 years.
  • 4. Measurement of the INR by the Thrombosis Service Leiden.
  • 5. Informed consent.
  • 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

  • 1. Treatment for liver failure.
  • 2. Dialysys, both peritoneal as hemodialysys.
  • 3. Pregnancy or wish to get pregnant, lactational period.
  • 4. Known to have a chronic condition with a life expectancy of less than 6 months.
  • 5. An expected interruption of treatment with oral anticoagulants for one week or longer.
  • 6. Participation of the self management protocol.

研究者

发起方
Dutch Heart Foundation

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