, Volume 1463, Issue 1, p 1
Date: 03 Aug 2013

Clopidogrel lacks efficacy for shunt thrombosis prevention in infants

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Clopidogrel [Plavix] does not reduce mortality from any cause or shunt-related morbidity in infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary-artery shunt.

This is the main finding of CLARINET

Clopidogrel to Lower Arterial Thrombotic Risk in Neonates and Infants Trial

, a multicentre, double-blind trial funded by Sanofi-Aventis and Bristol-Myers Squibb. The trial enrolled 906 infants aged ≤ 92 days at 134 sites in Europe, Asia, North and South America, and Africa between November 2006 through February 2010. The infants were randomised to receive clopidogrel 0.2 mg/kg/day, formulated as a syrup (n = 467), or matching placebo, after shunt placement.

The rate of the primary composite efficacy end point, defined as the earliest occurrence of death or heart transplantation, shunt thrombosis requiring intervention or a cardiac procedure performed before 120 days of age because of an event adjudicated to be thrombotic, was similar in infants who received clopid