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

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

[1]	Included
[2]	Completed follow-up

Baseline Characteristics

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