EUCTR2016-001247-39-GB进行中（未招募）1 期
A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention - Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 215
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
- •Males and females, 37 weeks adjusted gestational age to < 18 years of age
- •Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
- •Eligible patients include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
- •Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]
- •Participants 28 days to <3 months must be able to tolerate oral/NGT/GT feed for at least 5 days prior to randomization.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 215
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Recent thromboembolic events less than 6 months prior to enrollment
- •Use of aggressive life-saving therapies such as ventricular assist
- •devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the
- •time of enrollment
- •Artificial heart valves and mechanical heart valves
- •Known inherited bleeding disorder or coagulopathy (e.g. hemophilia,
- •von Willebrand disease, etc.)
- •Active bleeding at the time of enrollment
- •Any major bleeding other than perioperative in the preceding 3 months
- •Known intracranial congenital vascular malformation or tumor
- •Confirmed diagnosis of a GI ulcer
- •Known Antiphospholipid Syndrom (APS).
研究者
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