NCT00833703|CompletedPhase 3ResultsDMC

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

CLARINET LT

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

Sanofi ClinicalTrials.gov

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2 other identifiers

LTS109162008-004999-53

Study Type

interventional

Target

Locations

15 countries

Sites

Timeline

RegisteredFeb 2009

StartedJan 2009

CompletionJul 2010

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jan 2009

Geographic Reach

15 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

January 1, 2009

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

August 16, 2011

Completed

Last Updated

August 22, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

January 29, 2009

Results QC Date

July 20, 2011

Last Update Submit

August 18, 2011

Conditions

Heart Defects, Congenital

Keywords

cyanotic congenital heart diseaseshunt palliationthrombosisclopidogrel

Outcome Measures

Primary Outcomes (2)

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
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

Secondary Outcomes (1)

Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths
Up to a maximum of 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.2 mL/kg/day matching placebo solution once daily.

Drug: placebo

Clopidogrel 0.2 mg/kg/day

EXPERIMENTAL

0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.

Drug: Clopidogrel

Interventions

ClopidogrelDRUG

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

Also known as: SR25990, Plavix

Clopidogrel 0.2 mg/kg/day

placeboDRUG

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

Placebo

Eligibility Criteria

Age12 Months+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Contact the study team to confirm eligibility.