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



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:1/10/2019
Start Date:January 4, 2017
End Date:October 1, 2021
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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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

To investigate the safety and pharmacokinetics of apixaban in children with congenital or
acquired heart disease who have a need for anticoagulation.


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
We found this trial at
14
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-1790
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-803-1153
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-764-5177
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-6329
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Caba, Buenos Aires
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-876-1698
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Phone: 832-826-5915
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Phone: 317-278-7188
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Phone: 858-246-0155
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Phoenix, Arizona 85016
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Salt Lake City, Utah 84143
Phone: 801-213-7613
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