Conditions: Heart Defects, Congenital
Keywords: cyanotic congenital heart disease shunt palliation thrombosis clopidogrel
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: no

Brief 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.

Detailed description:
Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

Arms:
arm 1: 0.2 mL/kg/day matching placebo solution once daily. arm 2: 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.

Interventions: intervention 1: Clopidogrel intervention 2: placebo
Intervention descriptions: intervention 1: Form: reconstituted solution using Clopidogrel powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight intervention 2: Form: reconstituted solution using matching placebo powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Protocol document: