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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
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Heart Defects, Congenital
Interventions: Drug: Clopidogrel
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
49 participants were enrolled between January 2009 and January 2010 in 25 sites in 15 countries (7 countries involved in CLARINET study were not selected as the delay in obtaining IRB/IEC and Health Authorities approvals would prevent recruitment and/or no patient would be recruited as the second surgery is always performed before 1 year of age).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo 0.2 mL/kg/day matching placebo solution once daily
Clopidogrel 0.2 mg/kg/Day 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily

Participant Flow:   Overall Study
    Placebo     Clopidogrel 0.2 mg/kg/Day  
STARTED     23 [1]   26 [1]
Treated     23     26  
Completed Treatment     22     24  
COMPLETED     23 [2]   25 [2]
NOT COMPLETED     0     1  
Parent(s)/guardian(s)'s request                 0                 1  
[1] Included
[2] Completed follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 0.2 mL/kg/day matching placebo solution once daily
Clopidogrel 0.2 mg/kg/Day 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Clopidogrel 0.2 mg/kg/Day     Total  
Number of Participants  
[units: participants]
  23     26     49  
Age  
[units: days]
Mean ± Standard Deviation
     
at randomization in CLARINET study     45.2  ± 26.1     33.1  ± 20.5     38.8  ± 23.8  
at inclusion     368.1  ± 4.2     368.0  ± 2.7     368.0  ± 3.5  
Gender  
[units: participants]
     
Female     10     14     24  
Male     13     12     25  
Region of Enrollment  
[units: participants]
     
United States     0     1     1  
Portugal     3     1     4  
Taiwan     4     5     9  
Spain     0     2     2  
Russian Federation     1     0     1  
United Kingdom     1     2     3  
Italy     0     1     1  
India     0     1     1  
France     0     1     1  
Hungary     2     1     3  
Mexico     6     4     10  
Brazil     4     2     6  
Malaysia     1     1     2  
Poland     1     1     2  
Germany     0     3     3  
Weight at inclusion  
[units: kilogramsĀ (kg)]
Mean ± Standard Deviation
  7.9  ± 1.1     8.1  ± 1.2     8.0  ± 1.2  
Height at inclusion  
[units: centimetersĀ (cm)]
Mean ± Standard Deviation
  71.8  ± 2.8     70.0  ± 10.4     70.8  ± 7.8  
Type of initial shunt palliation  
[units: participants]
     
Modified Blalock Taussig Shunt with Norwood     0     1     1  
Modified Blalock Taussig Shunt without Norwood     18     20     38  
Sano procedure with Norwood     0     0     0  
Sano procedure without Norwood     1     1     2  
Central shunt     1     3     4  
Stent of ductus arteriosus     3     1     4  
Shunt on cardiopulmonary bypass  
[units: participants]
     
Yes     2     5     7  
No     21     21     42  
Age at shunt palliation  
[units: days]
Mean ± Standard Deviation
  25.7  ± 28.7     13.7  ± 12.7     19.4  ± 22.3  



  Outcome Measures
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1.  Primary:   Number of Participants With Bleeding Events   [ Time Frame: Up to a maximum of 6 months ]

2.  Primary:   Number of Participants According to Bleeding Type/Etiology   [ Time Frame: Up to a maximum of 6 months ]

3.  Secondary:   Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths   [ Time Frame: Up to a maximum of 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: sanofi-aventis
e-mail: Contact_US@sanofi-aventis.com


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00833703     History of Changes
Other Study ID Numbers: LTS10916, 2008-004999-53
Study First Received: January 29, 2009
Results First Received: July 20, 2011
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration