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Recruiting

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

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • 0-17

    Age Range

  • 40

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com