Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation (CLARINET)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Heart Defects, Congenital

Treatments

Drug: placebo

Drug: Clopidogrel (SR25990)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396877

2006-000946-38 (EudraCT Number)

EFC5314

Details and patient eligibility

About

Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.

The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).

The secondary objective was to assess the safety of Clopidogrel in the study population.

Full description

In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.

The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.

Enrollment

906 patients

Sex

All

Ages

Under 92 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.

Exclusion criteria

Active bleeding or increase risk of bleeding,
Allergy to 2 or more classes of drug,
Unable to receive drug orally or enterically,
Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure.