Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
Contemporary management of cyanotic congenital heart disease includes three stages of
surgery. Incidence of shunt thrombosis and death between the two first stages of palliation
remains important.
The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day
for the reduction of all cause mortality and shunt related morbidity in neonates or infants
with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt
(e.g. modified Blalock Taussig Shunt [BTS]).
The secondary objective was to assess the safety of Clopidogrel in the study population.