Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

Phase 3

Completed

• Conditions: Heart Defects, Congenital
• Interventions: Drug: placebo; Drug: Clopidogrel

• Registration Number: NCT00833703
• Lead Sponsor: Sanofi

Brief Summary

This study is the extension of the CLARINET study \[NCT00396877 -EFC5314\] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

Detailed Description

Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-20
• Results First Submitted QC: 2011-07-20
• Status Verified: 2011-08
• Results First Posted: 2011-08-16
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Patients randomized in the CLARINET study,
• Still receiving the study drug,
• Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,
• Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,
• Signed informed consent to participate in the long-term safety study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	0.2 mL/kg/day matching placebo solution once daily.
Clopidogrel 0.2 mg/kg/day	Clopidogrel	0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Bleeding Events	Up to a maximum of 6 months	All bleeding events experienced during the study period were collected as for any Adverse Event.; The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.
Number of Participants According to Bleeding Type/Etiology	Up to a maximum of 6 months	For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths	Up to a maximum of 6 months	Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.; Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first).

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom