Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

Heart Defects, Congenital Clinical Trial

— CLARINET LT  

Official title:

Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833703
• Other study ID #: LTS10916
• Secondary ID: 2008-004999-53
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2009
• Last updated: August 18, 2011
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

Description:

Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

Inclusion Criteria:

• Patients randomized in the CLARINET study,

• Still receiving the study drug,

• Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,

• Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,

• Signed informed consent to participate in the long-term safety study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Drug:
• Clopidogrel
Form: reconstituted solution using Clopidogrel powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight
• placebo
Form: reconstituted solution using matching placebo powder Route: oral or enteric Frequency: once daily Dose: daily dose adjusted for weight

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Hungary	Sanofi-Aventis Administrative Office	Budapest
India	Sanofi-Aventis Administrative Office	Mumbai
Italy	Sanofi-Aventis Administrative Office	Milano
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Mexico	Sanofi-Aventis Administrative Office	Mexico
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Spain	Sanofi-Aventis Administrative Office	Barcelona
Taiwan	Sanofi-Aventis Administrative Office	Taipei
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Brazil,  France,  Germany,  Hungary,  India,  Italy,  Malaysia,  Mexico,  Poland,  Portugal,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Bleeding Events	All bleeding events experienced during the study period were collected as for any Adverse Event.; The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.	Up to a maximum of 6 months	Yes
Primary	Number of Participants According to Bleeding Type/Etiology	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.	Up to a maximum of 6 months	Yes
Secondary	Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths	Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.; Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first).	Up to a maximum of 6 months	No