Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or
infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery
shunt.
The primary objective was to assess the safety up to 18 months of age of the extended use of
Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of
age.
The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis
requiring intervention or any death.