Phase 3
N=906
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
Heart Defects, Congenital
Bottom Line
View on ClinicalTrials.gov: NCT00396877 ↗Enrolled (actual)
906
Serious AEs
47.8%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature) — 90; 89; 60; 51 participants — p=0.4340
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clopidogrel (SR25990) (Drug); placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature) |
90; 89; 60; 51; 21; 26 | 0.4340 |
| SECONDARY Number of Participants With Bleeding Events |
88; 87; 32; 30; 1; 1 | — |
| SECONDARY Number of Participants According to Bleeding Type/Etiology |
60; 56; 6; 11; 19; 9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00396877). 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.