Status:
COMPLETED
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Heart Defects, Congenital
Eligibility:
All Genders
Up to 92 years
Phase:
PHASE3
Brief 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. Th...
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 ...
Eligibility Criteria
Inclusion
- Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
906 Patients enrolled
Trial Details
Trial ID
NCT00396877
Start Date
November 1 2006
End Date
February 1 2010
Last Update
October 24 2014
Active Locations (31)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 94609
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Diegem, Belgium
4
Sanofi-Aventis Administrative Office
São Paulo, Brazil