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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Clopidogrel; Pharmaceutical Solutions; Ticlopidine

Criteria

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.