Complete Obstruction of Systemic to Pulmonary Artery Shunt, Partial Obstruction of Systemic to Pulmonary Artery Shunt
Conditions
Brief summary
The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.
Interventions
DRUGCangrelor
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
1. Males and females with congenital heart disease, and ranging in age from birth through 28 days of life 2. Postoperative neonatal cardiac participants with placement of systemic-to-pulmonary artery palliative shunts, right ventricle to pulmonary artery palliative shunts, or ductus arteriosus stents who are at risk of thrombotic events after repair for structural congenital heart disease. 3. Written informed consent from a parent/legal guardian 4. Life expectancy of at least 15 days at study entry Participants will be excluded from the study if any of the following
Exclusion criteria
apply: 1. History of intracerebral bleed (confirmed by a ultrasound (US) of the head prior to surgery), or cerebral arteriovenous malformation, or any prior bleed with neurological deficit 2. Gastrointestinal or urinary bleeding 3. Cerebrovascular accident or any cerebrovascular accident with a residual neurological deficit 4. Known congenital or acquired bleeding or clotting disorder 5. Weight less than 2.5 kilograms (kg) 6. Adjusted gestational age less than 37 weeks 7. Platelet count less than 100,000 cells/microliter (µL) 8. Chest and/or mediastinal tube blood output of greater than 3 milliliters (mL)/kg/hour (hr) at the time of cangrelor administration 9. Participants with evidence of severe hepatic or renal failure \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times normal for age or total bilirubin greater than 20 milligrams (mg)/deciliter (dL); creatinine greater than 2 times the normal upper limit\] 10. Known allergy to cangrelor or known sensitivity to any component of cangrelor 11. Any condition that in the investigator's opinion would constitute a contraindication to participation in the study or cause inability to comply with the study requirements 12. Participation in another investigational therapeutic drug or investigational therapeutic device trial within 30 days of starting study 13. Participants who have been receiving warfarin (Coumadin®) therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total plasma concentrations of cangrelor and its primary metabolite, AR C69712, during administration and after cessation of the infusion in neonates | During study drug infusion through 8 hours post infusion |
| Proportion of participants in each cohort who achieve ≥90% inhibition of final platelet aggregation as measured by light transmittance aggregometry (LTA) using 20 micromolar (µM) adenosine diphosphate (ADP) in platelet rich plasma | During study drug infusion through 1 hour post infusion |
| Individual recovery of platelet function in neonates after cessation of the infusion | Up to 1 hour post infusion |
| Assessment of the safety of cangrelor in neonatal participants by evaluating adverse events (AEs) and serious adverse events (SAEs) | from start of cangrelor infusion through 48 hours post cangrelor infusion |
Countries
United States
Outcome results
None listed