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Cangrelor Neonatal PK/PD and Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02765633
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : February 5, 2020
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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.

Condition or disease Intervention/treatment Phase
Partial Obstruction of Systemic to Pulmonary Artery Shunt Complete Obstruction of Systemic to Pulmonary Artery Shunt Drug: Cangrelor Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cangrelor

Arm Intervention/treatment
Experimental: Cangrelor
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

Primary Outcome Measures :
  1. Total plasma concentrations of cangrelor and its primary metabolite, AR C69712, during administration and after cessation of the infusion in neonates [ Time Frame: During study drug infusion through 8 hours post infusion ]
  2. 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 [ Time Frame: During study drug infusion through 1 hour post infusion ]
  3. Individual recovery of platelet function in neonates after cessation of the infusion [ Time Frame: Up to 1 hour post infusion ]
  4. Assessment of the safety of cangrelor in neonatal participants by evaluating adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from start of cangrelor infusion through 48 hours post cangrelor infusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02765633

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Principal Investigator: Thomas Diacovo, MD Columbia University
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Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT02765633    
Other Study ID Numbers: MDCO-CAN-15-01
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs