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临床试验/NCT02981472
NCT02981472已完成2 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

Bristol-Myers Squibb42 个研究点 分布在 13 个国家目标入组 192 人开始时间: 2017年1月19日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
192
试验地点
42
主要终点
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
28 Days 至 17 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Males and Females, 28 days to < 18 years of age, inclusive
  • •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 participants 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/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization

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
  • •Known antiphospholipid syndrome (APS).
  • •Other protocol defined inclusion/exclusion criteria apply

研究组 & 干预措施

LMWH/VKA

Active Comparator

干预措施: Low Molecular Weight Heparin (LMWH) (Drug)

LMWH/VKA

Active Comparator

干预措施: Vitamin K Antagonist (VKA) (Drug)

Apixaban

Experimental

干预措施: Apixaban (Drug)

结局指标

主要结局

Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events

时间窗: From first dose to 2 days after last dose (Up to approximately 12 months)

The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology. CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.

次要结局

  • The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death(From randomization to 2 days after last dose (Up to approximately 12 months))
  • The Number of Participants With All Adjudicated Bleeding(From first dose to 2 days after last dose (Up to approximately 12 months))
  • Time of Maximum Observed Concentration (Tmax)(From first dose up to 6 months after first dose)
  • The Number of Participants With Adjudicated CRNM Bleeding(From first dose to 2 days after last dose (Up to approximately 12 months))
  • The Number of Participant Deaths in the Study(From first dose to 2 days after last dose (Up to approximately 12 months))
  • Maximum Observed Concentration (Cmax)(From first dose up to 6 months after first dose)
  • Trough Observed Concentration (Cmin)(From first dose up to 6 months after first dose)
  • Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))(From first dose up to 6 months after first dose)
  • The Number of Participants With Adjudicated Major Bleeding(From first dose to 2 days after last dose (Up to approximately 12 months))
  • The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding(From first dose to 2 days after last dose (Up to approximately 12 months))
  • Anti-FXa Activity(From first dose up to 6 months after first dose)
  • Chromogenic FX Assay (Apparent FX Level)(From first dose up to 6 months after first dose)
  • The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)(from randomization up to 12 months after randomization)
  • Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score(from randomization up to 12 months after randomization)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (42)

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