Heart Defects, Congenital Clinical Trial
Official title:
International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt
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.
In this event-driven study, participants were to be randomized and treated as soon as
possible after shunt placement. They were then to be treated and followed until the primary
endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for
correction of the congenital heart disease or death) or one year of age or the common
study-end-date, which ever came first.
The common study-en-date was defined as the date when it was projected that 172 participants
would have reached the primary endpoint criteria.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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