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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.

Exclusion Criteria:

• Active bleeding or increase risk of bleeding,

• Allergy to 2 or more classes of drug,

• Unable to receive drug orally or enterically,

• Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure.