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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00396877
First received: November 7, 2006
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: February 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Defects, Congenital
Interventions: Drug: Clopidogrel (SR25990)
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
Recruitment was initially planned with a minimum of 490 participants anticipating that it would continue until a total of 172 participants reaching primary endpoint criteria is achieved. Finally 906 participants were enrolled and randomized between November 2006 and October 2009 in 134 sites in 31 countries. Actual median follow-up was 5.8 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A participant was considered randomized when informed consent had been obtained and there was confirmation of successful allocation of a randomization number through the study treatment allocation system (Interactive Voice Response System).

Reporting Groups
  Description
Placebo Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
Clopidogrel 0.2 mg/kg/Day

Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight


Participant Flow:   Overall Study
    Placebo   Clopidogrel 0.2 mg/kg/Day
STARTED   439 [1]   467 [1] 
Treated   436   464 
Completed Treatment   356   352 
COMPLETED   433 [2]   459 [2] 
NOT COMPLETED   6   8 
Lost to Follow-up                2                1 
Parent(s)/guardian(s)'s request                4                7 
[1] Randomized
[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 No text entered.
Clopidogrel 0.2 mg/kg/Day No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo   Clopidogrel 0.2 mg/kg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 439   467   906 
Age 
[Units: Days]
Mean (Standard Deviation)
 36.0  (22.5)   36.1  (22.3)   36.1  (22.4) 
Age, Customized 
[Units: Participants]
     
≤ 30 days   223   238   461 
30 (<) - 92 days   216   229   445 
Gender 
[Units: Participants]
     
Female   185   198   383 
Male   254   269   523 
Region of Enrollment 
[Units: Participants]
     
United States   90   88   178 
Portugal   10   10   20 
Taiwan   12   10   22 
Hong Kong   1   0   1 
Thailand   2   3   5 
Spain   16   14   30 
Israel   3   4   7 
Russian Federation   13   15   28 
Italy   20   19   39 
India   20   27   47 
France   11   10   21 
Malaysia   5   4   9 
Denmark   3   3   6 
South Africa   13   13   26 
Netherlands   2   4   6 
China   10   11   21 
Korea, Republic of   3   2   5 
Finland   2   1   3 
United Kingdom   16   16   32 
Egypt   4   6   10 
Hungary   9   9   18 
Mexico   32   37   69 
Canada   5   6   11 
Argentina   24   28   52 
Brazil   31   34   65 
Belgium   9   12   21 
Poland   3   7   10 
Singapore   2   2   4 
Germany   54   59   113 
Norway   8   8   16 
Sweden   6   5   11 
Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 3.5  (0.7)   3.4  (0.7)   3.5  (0.7) 
Height 
[Units: Centimeters (cm)]
Mean (Standard Deviation)
 51.8  (4.6)   51.4  (4.4)   51.6  (4.5) 
Type of systemic-to-pulmonary artery shunt palliation [1] 
[Units: Participants]
     
Modified Blalock Taussig Shunt with Norwood   51   62   113 
Modified Blalock Taussig Shunt without Norwood   252   257   509 
Sano procedure with Norwood   54   60   114 
Sano procedure without Norwood   2   5   7 
Central shunt   38   40   78 
Stent of ductus arteriosus   42   42   84 
Not applicable   0   1   1 
[1] One participant didn't have a systemic-to-pulmonary artery shunt but underwent stenting of the right ventricular outflow track.
Shunt on cardiopulmonary bypass 
[Units: Participants]
     
Yes   177   194   371 
No   262   273   535 
Age at shunt palliation 
[Units: Days]
Mean (Standard Deviation)
 16.0  (18.7)   16.2  (18.6)   16.1  (18.7) 
Time from shunt palliation to randomization 
[Units: Participants]
     
≤ 1 week   116   113   229 
1 (<) to 2 weeks   105   126   231 
2 (<) to 4 weeks   117   119   236 
> 4 weeks   101   109   210 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00396877     History of Changes
Other Study ID Numbers: EFC5314
2006-000946-38 ( EudraCT Number )
Study First Received: November 7, 2006
Results First Received: February 15, 2011
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration