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Completed

NCT Number: NCT00396877

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

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Heart Diseases Thrombosis Vascular Diseases

Age range

Up to 92 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

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About this study

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 i.e. (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel (SR25990)

Drug

Form: reconstituted solution using Clopidogrel powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Other names: Plavix

Placebo

Drug

Form: reconstituted solution using matching placebo powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Primary outcomes

  1. Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)

    Time frame: Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)

    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.

Secondary outcomes

  1. Number of Participants With Bleeding Events

    Time frame: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first

    Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.

    The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted.

  2. Number of Participants According to Bleeding Type/Etiology

    Time frame: From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first

    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. Participants who had multiple bleedings could be counted several times.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: CLARINET

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 8, 2006
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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