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

CompletadoFase 2ClinicalTrials.gov

ID: NCT02981472Tipo: INTERVENTIONALInicio: 19 de ene de 2017Fin estimado: 18 de oct de 2021

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 28 DaysEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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

Criterios de exclusión

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).

Intervenciones

drug

Apixaban

Specified dose on specified days

drug

Vitamin K Antagonist (VKA)

Specified dose on specified days

drug

Low Molecular Weight Heparin (LMWH)

Specified dose on specified days

Ubicaciones

Local Institution

CABA, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorPediatric Heart Network

ColaboradorPfizer

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