NCT00396877|CompletedPhase 3ResultsDMC

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

CLARINET

International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC53142006-000946-38

Study Type

interventional

Target

906

Locations

31 countries

Sites

Timeline

RegisteredNov 2006

StartedNov 2006

CompletionFeb 2010

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 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

906

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2006

Typical duration for phase_3

Geographic Reach

31 countries

31 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

3.3 years study duration

Study Start

First participant enrolled

November 1, 2006

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 11, 2011

Completed

Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

3.3 years

First QC Date

November 7, 2006

Results QC Date

February 15, 2011

Last Update Submit

October 14, 2014

Conditions

Heart Defects, Congenital

Keywords

cyanotic congenital heart diseaseshunt palliationthrombosisclopidogrel

Outcome Measures

Primary Outcomes (1)

Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)
The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee. Only the first event was counted.
Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)

Secondary Outcomes (2)

Number of Participants With Bleeding Events
From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first
Number of Participants According to Bleeding Type/Etiology
From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Clopidogrel 0.2 mg/kg/day

EXPERIMENTAL

Drug: Clopidogrel (SR25990)

Interventions

Clopidogrel (SR25990)DRUG

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

Also known as: 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

AgeUp to 92 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.

You may not qualify if:

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.

Contact the study team to confirm eligibility.