A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
NCT02981472
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | |||||||||
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Brief Title ICMJE | A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief Summary | To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
Condition ICMJE | Thrombosis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 200 | ||||||||
Original Estimated Enrollment ICMJE | 150 | ||||||||
Estimated Study Completion Date ICMJE | October 1, 2021 | ||||||||
Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply | ||||||||
Sex/Gender ICMJE |
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Ages ICMJE | up to 17 Years (Child) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Austria, Brazil, Canada, Finland, France, Germany, Israel, Italy, Mexico, Russian Federation, Spain, United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02981472 | ||||||||
Other Study ID Numbers ICMJE | CV185-362 2016-001247-39 ( EudraCT Number ) | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Bristol-Myers Squibb | ||||||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |