Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

Last updated: August 18, 2011
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Birth Defects

Holoprosencephaly

Treatment

N/A

Clinical Study ID

NCT00833703
LTS10916
2008-004999-53
  • Ages > 12
  • All Genders

Study Summary

This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients randomized in the CLARINET study,

  • Still receiving the study drug,

  • Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,

  • Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,

  • Signed informed consent to participate in the long-term safety study.

Study Design

Total Participants: 49
Study Start date:
January 01, 2009
Estimated Completion Date:
July 31, 2010

Study Description

Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

Connect with a study center

  • Sanofi-Aventis Administrative Office

    Sao Paulo,
    Brazil

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Paris,
    France

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Berlin,
    Germany

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Budapest,
    Hungary

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Mumbai,
    India

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Milano,
    Italy

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Mexico,
    Mexico

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Warszawa,
    Poland

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Porto Salvo,
    Portugal

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Moscow,
    Russian Federation

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Barcelona,
    Spain

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Taipei,
    Taiwan

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Guildford Surrey,
    United Kingdom

    Site Not Available

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey 08807
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.