NCT00833703

Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
DRUG	Clopidogrel	Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight
DRUG	placebo	Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-02-02
• Last updated: 2011-08-22
• Results posted: 2011-08-16

Locations

15 sites across 15 countries: United States, Brazil, France, Germany, Hungary, India, Italy, Malaysia, Mexico, Poland, Portugal, Russia, Spain, Taiwan, United Kingdom