EUCTR2016-001247-39-AT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, 28 days to 17 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 monts 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
- •Weight < 3 kg
- •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
- •Know antiphospholipid syndrom (APS)
研究者
相似试验
进行中（未招募）
1 期
Study of the Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulatioCongenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism PreventionMedDRA version: 20.0Level: PTClassification code 10019273Term: Heart disease congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10019276Term: Heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2016-001247-39-FIBristol-Myers Squibb International Corporation150
进行中（未招募）
1 期
Study of the Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulatioCongenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism PreventionMedDRA version: 20.0Level: PTClassification code 10019273Term: Heart disease congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10019276Term: Heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 21.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2016-001247-39-GBBristol-Myers Squibb International Corporation215
进行中（未招募）
1 期
Study of the Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulatioCongenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism PreventionMedDRA version: 20.0Level: PTClassification code 10019273Term: Heart disease congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10019276Term: Heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2016-001247-39-DEBristol-Myers Squibb International Corporation192
进行中（未招募）
1 期
Study of the Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulatioCongenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism PreventionMedDRA version: 19.1Level: PTClassification code 10019273Term: Heart disease congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 19.1Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 19.1Level: LLTClassification code 10019276Term: Heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 19.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.1Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2016-001247-39-ITBristol-Myers Squibb International Corporation150
进行中（未招募）
1 期
Study of the Safety and Pharmacokinetics of apixaban versus Vitamin K Antagonist or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulatioCongenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism PreventionMedDRA version: 20.0Level: PTClassification code 10019273Term: Heart disease congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10019276Term: Heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2016-001247-39-ESBristol-Myers Squibb International Corporation192