EUCTR2009-016994-13-AT进行中（未招募）不适用
EUropean Pharmacogenetics of AntiCoagulation Therapy trial - EU-PACT
niversity Utrecht0 个研究点目标入组 2,955 人开始时间: 2012年8月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,955
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.Patients with either venous thromboembolism (VTE) or atrial fibrillation (AF) requiring coumarin therapy for at least 12 weeks and a target INR in the low intensity range (INR range 2-3 in the United Kingdom, Sweden, Germany, Austria, Greece and Spain and INR 2.5-3.5 in the Netherlands)
- •2.Age = 18 years
- •3.Ability to attend scheduled visits
- •4.Signed 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.Abnormal clotting function at baseline (at least one of):
- •a.INR >1.5
- •b.platelet count <100 x 109/L
- •c.prolonged APTT >1.3 times the upper reference value that is not explained by presence of lupus anticoagulants
- •2.Presence of a mechanical heart valve
- •3.Severe cognitive impairment
- •4.Known genotype CYP2C9 or VKORC1 at start of the study
- •5.Previous or current treatment with any coumarin
- •6.Pregnancy or lactation
- •7.Non-eligible subject, e.g. fysical or mental health problems.
研究者
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