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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00396877
First received: November 7, 2006
Last updated: October 14, 2014
Last verified: October 2014

November 7, 2006
October 14, 2014
November 2006
February 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]

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.

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.
Complete list of historical versions of study NCT00396877 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]

    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.
incidence of adverse events and serious adverse events including bleeding.
Not Provided
Not Provided
 
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Defects, Congenital
  • Drug: Clopidogrel (SR25990)

    Form: reconstituted solution using Clopidogrel powder

    Route: oral or enteric

    Frequency: once daily

    Dose: daily dose adjusted for weight

    Other Name: Plavix
  • Drug: placebo

    Form: reconstituted solution using matching placebo powder

    Route: oral or enteric

    Frequency: once daily

    Dose: daily dose adjusted for weight

  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: Clopidogrel 0.2 mg/kg/day
    Intervention: Drug: Clopidogrel (SR25990)
Wessel DL, Berger F, Li JS, Dähnert I, Rakhit A, Fontecave S, Newburger JW; CLARINET Investigators. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
906
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
up to 92 Days
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   China,   Denmark,   Egypt,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom
 
NCT00396877
EFC5314, 2006-000946-38
Yes
Sanofi
Sanofi
Bristol-Myers Squibb
Study Director: International Clinical Development Clinical Study Director Sanofi
Sanofi
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP