CompletedPhase 3

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

United States, Brazil, France49 participantsStarted 2009-01

Plain-language 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.

Who can participate

Age range12 Months

SexALL

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Inclusion Criteria: * Patients randomized in the CLARINET study, * Still receiving the study drug, * Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age, * Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug, * Signed informed consent to participate in the long-term safety study.

What they're measuring

Number of Participants With Bleeding Events

Timeframe: Up to a maximum of 6 months

Number of Participants According to Bleeding Type/Etiology

Timeframe: Up to a maximum of 6 months

Trial details

NCT IDNCT00833703

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07

Results submitted2011-07-20

View on ClinicalTrials.gov More Heart Defects, Congenital trials