deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02981472

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

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

Sponsor: Bristol-Myers Squibb

Conditions Thrombosis
Interventions Apixaban Low Molecular Weight Heparin (LMWH) Vitamin K Antagonist (VKA)
Updated 26 times since 2017 Last updated: Sep 29, 2022 Started: Jan 19, 2017 Primary completion: Oct 18, 2021 Completion: Oct 18, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Thrombosis and is currently completed. Bristol-Myers Squibb leads this study, which shows 26 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Apr 2017 · 31 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Sep 2017 · 2 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Oct 2019 · 8 months · monthly snapshot~Oct 2019 – ~Jan 2020 · 3 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~May 2020 · 3 months · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshot~Jan 2022 – ~Jun 2022 · 5 months · monthly snapshot~Jun 2022 – ~Nov 2022 · 5 months · monthly snapshot~Nov 2022 – ~Jul 2024 · 20 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

26 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Nov 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2022 — Nov 2022 [monthly]

    Completed PHASE2

▶ Show 21 earlier versions

  1. Jan 2022 — Jun 2022 [monthly]

    Completed PHASE2

    Status: Recruiting → Completed

  2. Jan 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  3. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  4. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

  5. Jul 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

  6. May 2020 — Jul 2020 [monthly]

    Recruiting PHASE2

  7. Feb 2020 — May 2020 [monthly]

    Recruiting PHASE2

  8. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE2

  9. Oct 2019 — Jan 2020 [monthly]

    Recruiting PHASE2

  10. Feb 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  11. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2

  12. Jun 2018 — Jan 2019 [monthly]

    Recruiting PHASE2

  13. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  14. Dec 2017 — Mar 2018 [monthly]

    Recruiting PHASE2

  15. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE2

  16. Jul 2017 — Sep 2017 [monthly]

    Recruiting PHASE2

  17. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  18. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  19. Mar 2017 — Apr 2017 [monthly]

    Recruiting PHASE2

  20. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  21. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb
  • Pediatric Heart Network
  • Pfizer
Data source: Bristol-Myers Squibb

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Aurora, United States , Barcelona, Spain , Bologna, Italy , Boston, United States , Bristol, United Kingdom , CABA, Argentina , Campinas, Brazil , Charleston, United States and 32 more locations