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

Phase 3

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Clopidogrel 0.2 mg/kg/day	Clopidogrel (SR25990)	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)	Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)	The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Bleeding Events	From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first	Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event. The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted.
Number of Participants According to Bleeding Type/Etiology	From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first	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. Participants who had multiple bleedings could be counted several times.

Locations (3): Sanofi-Aventis Administrative Office
🇨🇳
Taipei, Taiwan
Sanofi-Aventis Admnistrative Office
🇬🇧
Guildford Surrey, United Kingdom
Sanofi-Aventis Administraive Office
🇹🇭
Bangkok, Thailand