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

Sponsor:	Sanofi-Aventis
Collaborator:	Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00396877

Purpose

Contemporary management of cyanotic congenital heart disease includes 3 stages of surgery. Incidence of shunt thrombosis and death between the 2 first stages of palliation remains important. The objective of the study is to evaluate the efficacy of clopidogrel 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.

Condition	Intervention	Phase
Heart Defects, Congenital	Drug: clopidogrel (SR25990C) Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

Resource links provided by NLM:

MedlinePlus related topics: Congenital Heart Defects Heart Diseases

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

First occurrence of any death or shunt thrombosis requiring intervention or hospitalization for any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered of thrombotic nature. [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

incidence of adverse events and serious adverse events including bleeding. [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	490
Study Start Date:	October 2006
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: clopidogrel (SR25990C) reconstituted solution
2: Placebo Comparator	Drug: placebo reconstituted solution

Eligibility

Ages Eligible for Study:	up to 92 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396877

Show 31 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5314, EudraCT : 2006-000946-38
Study First Received:	November 7, 2006
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00396877 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

cyanotic congenital heart disease
shunt palliation
thrombosis
clopidogrel

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Abnormalities
Therapeutic Uses
Clopidogrel
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010