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NCT02981472 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
NCT02981472: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT02981472 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 192 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02981472, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
Study Summary
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
Primary Outcome
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, bleedin
Interventions
- DRUG Apixaban
- DRUG Low Molecular Weight Heparin (LMWH)
- DRUG Vitamin K Antagonist (VKA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 2 |
What the finished NCT02981472 record still lists
NCT02981472 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 3 interventions - of which Apixaban is the first listed.
NCT02981472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02981472 about?
NCT02981472 is a clinical study titled "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". To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
What is the current status of trial NCT02981472?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2017-01-19. Estimated completion is 2021-10-18.
What interventions are being tested in trial NCT02981472?
The interventions under investigation include: Apixaban (DRUG), Low Molecular Weight Heparin (LMWH) (DRUG), Vitamin K Antagonist (VKA) (DRUG).
Who is sponsoring clinical trial NCT02981472?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02981472's enrollment target sits among peer trials
192 352nd of 2000 higher than 1,648 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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