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:
Sanofi
ClinicalTrials.gov Identifier:
NCT00396877
First received: November 7, 2006
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Heart Defects, Congenital
Drug: Clopidogrel (SR25990)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 906
Study Start Date: November 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 92 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396877

  Show 31 Study Locations
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: International Clinical Development Clinical Study Director Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00396877     History of Changes
Other Study ID Numbers: EFC5314, 2006-000946-38
Study First Received: November 7, 2006
Results First Received: February 15, 2011
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
cyanotic congenital heart disease
shunt palliation
thrombosis
clopidogrel

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014