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

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NCT02981472

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Study Location
Local Institution
Kazan, , 420012, Russian Federation
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Contact
please email:
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-17
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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NCT02981472
  1. Kazan,
  2. Kemerovo,
  3. Phoenix, Arizona
  4. La Jolla, California
  5. Aurora, Colorado
  6. Wilmington, Delaware
  7. Atlanta, Georgia
  8. Indianapolis, Indiana
  9. Boston, Massachusetts
  10. Ann Arbor, Michigan
  11. Kansas City, Missouri
  12. Cincinnati, Ohio
  13. Philadelphia, Pennsylvania
  14. Charleston, South Carolina
  15. Houston, Texas
  16. Salt Lake City, Utah
  17. Seattle, Washington
  18. Caba, Buenos Aires
  19. Westmead, New South Wales
  20. Parkville, Victoria
  21. Vienna,
  22. Brasilia, Distrito Federal
  23. Curitiba, Parana
  24. Porto Alegre, RIO Grande DO SUL
  25. Campinas, SAO Paulo
  26. Sao Paulo,
  27. Sao Paulo,
  28. Toronto, Ontario
  29. Helsinki,
  30. Marseille,
  31. Montpellier,
  32. Paris,
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  34. Freiburg,
  35. Hamburg,
  36. Muenchen,
  37. Tel Hashomer,
  38. Bologna,
  39. Milano,
  40. Roma,
  41. Mexico City, Distrito Federal
  42. Mexico City, Distrito Federal
  43. Mexico City, Distrito Federal
  44. Leon, Guanajuato
  45. Ekaterinburg,
  46. Novosibirsk,
  47. Barcelona,
  48. Madrid,
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  51. Bristol, Somerset
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  18. Ottawa, Ontario
  19. Toronto, Ontario
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Advanced Information
Descriptive Information
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
  • Drug: Apixaban
    Specified dose on specified days
    Other Name: Eliquis
  • Drug: Vitamin K Antagonist (VKA)
    Specified dose on specified days
    Other Name: Warfarin
  • Drug: Low Molecular Weight Heparin (LMWH)
    Specified dose on specified days
    Other Name: Enoxaparin
Study Arms  ICMJE
  • Experimental: Apixaban
    Intervention: Drug: Apixaban
  • Active Comparator: LMWH/VKA
    Interventions:
    • Drug: Vitamin K Antagonist (VKA)
    • Drug: Low Molecular Weight Heparin (LMWH)
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
 (submitted: September 6, 2019)		200
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2016)		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:

  • 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

Exclusion Criteria:

  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,please email:[email protected]
Contact: First line of the email MUST contain NCT# and Site #.
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Pediatric Heart Network
  • Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
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