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

Official Title: “International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg 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 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.

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 reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.

The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.

Intervention(s) in this Clinical Trial

• Drug: Clopidogrel (SR25990)
  • Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight
• Drug: placebo
  • Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
• Experimental: Clopidogrel 0.2 mg/kg/day

Primary Measures

• Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
  • Time Frame: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)
    Safety Issue?: No

Secondary Measures

• Number of Participants With Bleeding Events
  • Time Frame: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
    Safety Issue?: Yes
• Number of Participants According to Bleeding Type/Etiology
  • Time Frame: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
    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 Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

International Clinical Development Clinical Study Director Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

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