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”

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.

Study Type: Interventional

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

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Drug: clopidogrel (SR25990C)
  • reconstituted solution
• Drug: placebo
  • reconstituted solution

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• 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.
  • Time Frame: study period
    Safety Issue?: No

Secondary Measures

• incidence of adverse events and serious adverse events including bleeding.
  • Time Frame: study period
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 92 Days

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

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

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00396877

Study ID Number: EFC5314

ClinicalTrials.gov Identifier: NCT00396877

Health Authority: United States: Food and Drug Administration