Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396877
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2006-11-07
Brief Title:
Efficacy And Safety Of Clopidogrel In Neonates Infants With Systemic To Pulmonary Artery Shunt Palliation
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 02 mgkg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLARINET
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 02 mgkgday 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 eg modified Blalock Taussig Shunt BTS
The secondary objective was to assess the safety of Clopidogrel in the study population
The primary objective of the study is to evaluate the efficacy of Clopidogrel 02 mgkgday 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 eg 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 ie 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
The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-000946-38 | EUDRACT_NUMBER | None | None |