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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 - CV185-362

Updated: 6 October, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 0-17

    Age Range

  • 40


  • Recruiting

Treatment Options

Study Arms
Experimental: Apixaban
Drug: Apixaban
Active Comparator: LMWH/VKA
Drug: Vitamin K Antagonist (VKA) Drug: Low Molecular Weight Heparin (LMWH)

Key Eligibility Criteria

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

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Side Effects (Adverse Events) and other reportable events are defined here
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