NL-OMON32884已完成不适用
EUropean Pharmacogenetics of AntiCoagulant Therapy trial - EU-PACT trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 610
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with either venous thromboembolism (VTE) or atrial fibrillation (AF) requiring treatment with phenprocoumon 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
排除标准
- •1. Abnormal clotting function at baseline (at least one of):
- •a. INR >1.5
- •b. platelet count <100 x 10^9 per Liter blood
- •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
相似试验
已完成
不适用
European Pharmacogenetics of Anticoagulant TherapyStrokeISRCTN11629138niversity of Liverpool (UK)706
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A European study to the effects of genetic factors on anticoagulation treatment with phenprocoumon: The EU-PACT studyEUCTR2009-016994-13-DEniversity Utrecht2,955
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不适用
EUropean Pharmacogenetics of AntiCoagulation Therapy trial - EU-PACTewly diagnosed patients with venous tromboembolism (VTE) or atrial fibrillation (AF) requiring oral anticoagulation with phenprocoumon.MedDRA version: 12.1Level: LLTClassification code 10003658Term: Atrial fibrillationMedDRA version: 12.1Level: LLTClassification code 10012107Term: Deep venous thrombosis NOSMedDRA version: 12.1Level: LLTClassification code 10037377Term: Pulmonary embolismEUCTR2009-016992-31-NLDemocritus Universityof Thrace Medical School985