Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation (CLARINET LT)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00833703
First received: January 29, 2009
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.


Condition Intervention Phase
Heart Defects, Congenital
Drug: Clopidogrel
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants With Bleeding Events [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: Yes ]

    All bleeding events experienced during the study period were collected as for any Adverse Event.

    The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.


  • Number of Participants According to Bleeding Type/Etiology [ Time Frame: Up to a maximum of 6 months ] [ 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.


Secondary Outcome Measures:
  • Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: No ]

    Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.

    Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first).



Enrollment: 49
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0.2 mL/kg/day matching placebo solution once daily.
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
0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.
Drug: Clopidogrel

Form: reconstituted solution using Clopidogrel powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Other Names:
  • SR25990
  • Plavix

Detailed Description:

Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients randomized in the CLARINET study,
  • Still receiving the study drug,
  • Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,
  • Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,
  • Signed informed consent to participate in the long-term safety study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833703

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
India
Sanofi-Aventis Administrative Office
Mumbai, India
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00833703     History of Changes
Other Study ID Numbers: LTS10916, 2008-004999-53
Study First Received: January 29, 2009
Results First Received: July 20, 2011
Last Updated: August 18, 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 17, 2014