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Trial record 70 of 78 for:    sanofi-aventis and sweden

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00396877
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : March 11, 2011
Last Update Posted : October 24, 2014
Bristol-Myers Squibb
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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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Drug: Clopidogrel (SR25990) Drug: placebo Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 906 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo

Form: reconstituted solution using matching placebo powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Experimental: Clopidogrel 0.2 mg/kg/day 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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   up to 92 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00396877

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: International Clinical Development Clinical Study Director Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT00396877     History of Changes
Other Study ID Numbers: EFC5314
2006-000946-38 ( EudraCT Number )
First Posted: November 8, 2006    Key Record Dates
Results First Posted: March 11, 2011
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by Sanofi:
cyanotic congenital heart disease
shunt palliation

Additional relevant MeSH terms:
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Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs