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

Condition(s) targeted: Heart Defects, Congenital

Intervention: clopidogrel (SR25990C) (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
ICD CSD, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry ICD, Email: GV-Contact-us@sanofi-aventis.com

Contemporary management of cyanotic congenital heart disease includes 3 stages of surgery. Incidence of shunt thrombosis and death between the 2 first stages of palliation remains important. The objective of the study is to evaluate the efficacy of clopidogrel 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.

Official title: International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: First occurrence of any death or shunt thrombosis requiring intervention or hospitalization for any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered of thrombotic nature.

Secondary outcome: incidence of adverse events and serious adverse events including bleeding.

Minimum age: N/A. Maximum age: 92 Days. Gender(s): Both.

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

Public Registry ICD, Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Diegem, Belgium; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Sao Paulo, Brazil; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Laval, Canada; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Beijing, China; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Horsholm, Denmark; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Cairo, Egypt; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Helsinki, Finland; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Paris, France; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Berlin, Germany; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Causeway Bay, Hong Kong; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Budapest, Hungary; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Mumbai, India; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Natanya, Israel; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Milano, Italy; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Kuala Lumpur, Malaysia; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Mexico, Mexico; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Gouda, Netherlands; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Lysaker, Norway; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Warszawa, Poland; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Porto Salvo, Portugal; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Moscow, Russian Federation; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Singapore, Singapore; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Midrand, South Africa; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Barcelona, Spain; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Bromma, Sweden; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Taipei, Taiwan; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Bangkok, Thailand; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Guildford, Surrey, United Kingdom; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Starting date: October 2006
Ending date: April 2010
Last updated: September 25, 2008