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

History of Changes

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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Baseline Characteristics

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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: kilograms (kg)] Mean ± Standard Deviation	7.9 ± 1.1	8.1 ± 1.2	8.0 ± 1.2
Height at inclusion [units: centimeters (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 ]

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2. Primary:

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

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.

Limitations and Caveats

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.

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:

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.

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

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