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Clopidogrel in infants with systemic-to-pulmonary-artery shunts
David L Wessel1, Felix Berger, Jennifer S Li
1Children's National Medical Center, Washington, DC 20010, USA. dwessel@childrensnational.org
Insights
Clopidogrel did not reduce death or shunt complications in infants with cyanotic congenital heart disease. This study found no significant benefit of adding clopidogrel to conventional therapy for these high-risk infants.
Area of Science:
- Pediatric Cardiology
- Cardiovascular Surgery
- Pharmacology
Background:
- Infants with cyanotic congenital heart disease (CCHD) undergoing systemic-to-pulmonary artery shunt palliation face risks of shunt thrombosis and mortality.
- Conventional therapy, often including aspirin, is standard for these patients.
Purpose of the Study:
- To evaluate if adding clopidogrel to conventional therapy reduces all-cause mortality and shunt-related morbidity in infants with CCHD.
- To assess the efficacy and safety of clopidogrel in this vulnerable pediatric population.
Main Methods:
- A multicenter, double-blind, randomized trial assigned infants (≤92 days old) with CCHD and a shunt to receive either clopidogrel (0.2 mg/kg/day) or placebo.
- The primary endpoint was a composite of death, heart transplantation, shunt thrombosis, or thrombotic-related cardiac procedures before 120 days of age.
- Conventional therapy, including aspirin in most cases, was administered to both groups.
Main Results:
- The primary composite endpoint occurred in 19.1% of the clopidogrel group versus 20.5% of the placebo group, with no statistically significant difference.
- Clopidogrel did not show significant benefits in any subgroup, including by shunt type.
- Rates of overall and severe bleeding were similar between the clopidogrel and placebo groups.
Conclusions:
- Clopidogrel therapy, when added to conventional treatment (including aspirin in most infants), did not decrease mortality or shunt-related morbidity in infants with CCHD.
- The findings suggest clopidogrel is not effective for preventing adverse events in this specific patient group.
Background:
Infants with cyanotic congenital heart disease palliated with placement of a systemic-to-pulmonary-artery shunt are at risk for shunt thrombosis and death. We investigated whether the addition of clopidogrel to conventional therapy reduces mortality from any cause and morbidity related to the shunt.
Methods:
In a multicenter, double-blind, event-driven trial, we randomly assigned infants 92 days of age or younger with cyanotic congenital heart disease and a systemic-to-pulmonary-artery shunt to receive clopidogrel at a dose of 0.2 mg per kilogram of body weight per day (467 infants) or placebo (439 infants), in addition to conventional therapy (including aspirin in 87.9% of infants). The primary efficacy end point was a composite of death or heart transplantation, shunt thrombosis, or performance of a cardiac procedure due to an event considered to be thrombotic in nature before 120 days of age.
Results:
The rate of the composite primary end point did not differ significantly between the clopidogrel group (19.1%) and the placebo group (20.5%) (absolute risk difference, 1.4 percentage points; relative risk reduction with clopidogrel, 11.1%; 95% confidence interval, -19.2 to 33.6; P=0.43), nor did the rates of the three components of the composite primary end point. There was no significant benefit of clopidogrel treatment in any subgroup, including subgroups defined by shunt type. Clopidogrel recipients and placebo recipients had similar rates of overall bleeding (18.8% and 20.2%, respectively) and severe bleeding (4.1% and 3.4%, respectively).
Conclusions:
Clopidogrel therapy in infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary-artery shunt, most of whom received concomitant aspirin therapy, did not reduce either mortality from any cause or shunt-related morbidity. (Funded by Sanofi-Aventis and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00396877.).
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