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Clopidogrel · CLARINET

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

Ensayo de Sanofi en Heart Defects, Congenital (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

906

previstos

Centros

31

Fin del objetivo primario

feb 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en nov 2006.

Qué mide

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)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroContemporary 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00396877), actualizada en oct 2014.