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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00833703
First received: January 29, 2009
Last updated: August 18, 2011
Last verified: August 2011

January 29, 2009
August 18, 2011
January 2009
July 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Bleeding Events [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: Yes ]

    All bleeding events experienced during the study period were collected as for any Adverse Event.

    The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.

  • Number of Participants According to Bleeding Type/Etiology [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: Yes ]
    For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.
Safety evaluated by the incidence of adverse events and serious adverse events including bleeding. [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00833703 on ClinicalTrials.gov Archive Site
Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: No ]

Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.

Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first).

Efficacy assessed on the occurrence of shunt thrombosis requiring intervention or any death. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Heart Defects, Congenital
  • Drug: Clopidogrel

    Form: reconstituted solution using Clopidogrel powder

    Route: oral or enteric

    Frequency: once daily

    Dose: daily dose adjusted for weight

    Other Names:
    • SR25990
    • Plavix
  • Drug: placebo

    Form: reconstituted solution using matching placebo powder

    Route: oral or enteric

    Frequency: once daily

    Dose: daily dose adjusted for weight

  • Placebo Comparator: Placebo
    0.2 mL/kg/day matching placebo solution once daily.
    Intervention: Drug: placebo
  • Experimental: Clopidogrel 0.2 mg/kg/day
    0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.
    Intervention: Drug: Clopidogrel
Avlonitis VS, Planas S, Hayes AM, Parry A. Occlusion of modified Blalock-Taussig shunt after clopidogrel cessation. Ann Thorac Surg. 2012 Feb;93(2):656-8. doi: 10.1016/j.athoracsur.2011.07.071.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
12 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   France,   Germany,   Hungary,   India,   Italy,   Malaysia,   Mexico,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   United Kingdom
 
NCT00833703
LTS10916, 2008-004999-53
Yes
Sanofi
Sanofi
Bristol-Myers Squibb
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP