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

Summary

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

Timeline

Start

2017-01-19

Primary completion

2021-10-18

Completion

2021-10-18

Publications

• Payne RM, Burns KM, Glatz AC, Male C, Donti A, Brandao LR, Balling G, VanderPluym CJ, Bu'Lock F, Kochilas LK, Stiller B, Cnota JF 2nd, Rahkonen O, Khan A, Adorisio R, Stoica S, May L, Burns JC, Saraiva JFK, McHugh KE, Kim JS, Rubio A, Chia-Vazquez NG, Meador MR, Dyme JL, Reedy AM, Ajavon-Hartmann T, Jarugula P, Carlson-Taneja LE, Mills D, Wheaton O, Monagle P. Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease. J Am Coll Cardiol. 2023 Dec 12;82(24):2296-2309. doi: 10.1016/j.jacc.2023.10.010.

Drugs

Indications