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

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ClinicalTrials.gov Identifier: NCT00833703
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : August 16, 2011
Last Update Posted : August 22, 2011
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE January 29, 2009
First Posted Date  ICMJE February 2, 2009
Results First Submitted Date  ICMJE July 20, 2011
Results First Posted Date  ICMJE August 16, 2011
Last Update Posted Date August 22, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
  • Number of Participants With Bleeding Events [ Time Frame: Up to a maximum of 6 months ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
Safety evaluated by the incidence of adverse events and serious adverse events including bleeding. [ Time Frame: up to 6 months ]
Change History Complete list of historical versions of study NCT00833703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths [ Time Frame: Up to a maximum of 6 months ]
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
Efficacy assessed on the occurrence of shunt thrombosis requiring intervention or any death. [ Time Frame: up to 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Official Title  ICMJE 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
Brief 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.

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Heart Defects, Congenital
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2010)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2009)
32
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   France,   Germany,   Hungary,   India,   Italy,   Malaysia,   Mexico,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00833703
Other Study ID Numbers  ICMJE LTS10916
2008-004999-53 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date August 2011

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