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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: 07 May, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants 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)

  • 32

    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, 34 weeks adjusted gestational age to < 18 years of age - 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 patients 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] Exclusion Criteria: - Recent thromboembolic events less than 6 months prior to enrollment - 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 Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us