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:
Sanofi
ClinicalTrials.gov Identifier:
NCT00396877
First received: November 7, 2006
Last updated: March 24, 2011
Last verified: March 2011
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  
Number of Participants  
[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  
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  
[1] One participant didn't have a systemic-to-pulmonary artery shunt but underwent stenting of the right ventricular outflow track.



  Outcome Measures
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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


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00396877     History of Changes
Other Study ID Numbers: EFC5314, 2006-000946-38
Study First Received: November 7, 2006
Results First Received: February 15, 2011
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration