Cangrelor Neonatal PK/PD and Safety Study | NCT02765633

NCT02765633

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2016-000134-22	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cangrelor	Experimental	Cangrelor in up to four (4) dose cohorts consisting of a minimum of five participants in each cohort. One cohort of five participants will be enrolled at a time. Cohort 1 subjects will receive Cangrelor at 0.5 mcg/kg/min. Cohort 2 subjects will receive Cangrelor at 0.25 mcg/kg/min. Subsequent cohort dosing decisions are made at the completion of enrollment in each cohort.	Drug: Cangrelor

Name	Type	Description	Arm Group Labels	Other Names
Cangrelor	Drug		Cangrelor

Outcomes Module

Primary Outcomes

Measure	Description	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

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Males and females with congenital heart disease, and ranging in age from birth through 28 days of life
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.
Written informed consent from a parent/legal guardian
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:

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
Gastrointestinal or urinary bleeding
Cerebrovascular accident or any cerebrovascular accident with a residual neurological deficit
Known congenital or acquired bleeding or clotting disorder
Weight less than 2.5 kilograms (kg)
Adjusted gestational age less than 37 weeks
Platelet count less than 100,000 cells/microliter (µL)
Chest and/or mediastinal tube blood output of greater than 3 milliliters (mL)/kg/hour (hr) at the time of cangrelor administration
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]
Known allergy to cangrelor or known sensitivity to any component of cangrelor
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
Participation in another investigational therapeutic drug or investigational therapeutic device trial within 30 days of starting study
Participants who have been receiving warfarin (Coumadin®) therapy

Name	Affiliation	Role
Thomas Diacovo, MD	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center		New York	New York	10032	United States
UPMC Children's Hospital of Pittsburgh

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33078501	Result	Vargas D, Zhou H, Yu X, Diamond S, Yeh J, Allada V, Krishnamurthy G, Price M, Allen B, Alexander J, Schmidhofer J, Kreutzer J, Vincent J, Morell V, Bacha E, Diacovo T. Cangrelor PK/PD analysis in post-operative neonatal cardiac patients at risk for thrombosis. J Thromb Haemost. 2021 Jan;19(1):202-211. doi: 10.1111/jth.15141. Epub 2020 Nov 29.