Cangrelor Neonatal PK/PD and Safety Study

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