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Study of the Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulation

Mise à jour : Il y a 5 ans
Référence : U1111-1180-8978

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Extrait

The objectives of this study are to assess the following in pediatric subjects with congenital or acquired heart disease requiring chronic prophylactic anticoagulation: *the safety of apixaban *apixaban PK, PD (by measuring FX using chromogenic assay), and anti-FXa activity *the effects of apixaban versus VKA antagonists or LMWH on QOL measures *the efficacy of apixaban for thromboprophylaxis *biomarkers that may reflect anticoagulant efficacy or risk of thrombosis

Critère d'inclusion

  • Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention

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