Phase 3 N=49 Randomized Double-blind Treatment

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

Heart Defects, Congenital

Bottom Line

View on ClinicalTrials.gov: NCT00833703 ↗

Enrolled (actual)

Serious AEs

18.4%

Results posted

Aug 2011

Primary outcome: Primary: Number of Participants With Bleeding Events — 0; 2; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Clopidogrel (Drug); placebo (Drug)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Bleeding Events	0; 2; 0; 0; 0; 0	—
PRIMARY Number of Participants According to Bleeding Type/Etiology	0; 1; 0; 1	—
SECONDARY Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths	0; 0; 1; 0	—

Summary

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00833703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.