NCT00396877

Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 906 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 92 Days
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
DRUG	Clopidogrel (SR25990)	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: 2006-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2006-11-08
• Last updated: 2014-10-24
• Results posted: 2011-03-11

Locations

31 sites across 31 countries: United States, Argentina, Belgium, Brazil, Canada, China, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom