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

Sanofi49 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Defects, Congenital

Interventions

ClopidogrelDRUG

Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight

placeboDRUG

Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight

Eligibility

Sex: ALLMin age: 12 Months

Medical Language ↔ Plain English

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.

Locations (15)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Number of Participants With Bleeding Events

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.

Time frame: Up to a maximum of 6 months

Number of Participants According to Bleeding Type/Etiology

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.

Time frame: Up to a maximum of 6 months

Secondary Outcomes

Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths

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).

Time frame: Up to a maximum of 6 months

Data from ClinicalTrials.gov

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