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Completed

NCT Number: NCT04668495

Impact of Timing of PD Assessments on Measures of Platelet Reactivity in Patients Undergoing PCI Treated With Cangrelor

This study is assessing the impact of timing of PD assessments on measures of platelet reactivity in patients undergoing PCI treated with cangrelor.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

About this study

Cangrelor is characterized by reversible binding to the P2Y12 receptor and is promptly inactivated through dephosphorylation by ectonucleotidase leading to its very short plasma half-life. Consequently the timing at which PD assessments are performed after blood sample collection may impact measures of platelet reactivity in patients treated with cangrelor. We therefore hypothesize that measures of platelet inhibitory effects observed in cangrelor treated patients will reduce with time following blood sampling.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years old
  • CAD patients (stable CAD, NSTE-ACS, or STEMI) undergoing PCI and treated with cangrelor per standard of care.
  • Treated with aspirin prior to the PCI procedure per standard of care

Exclusion criteria

  • Treatment with an oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) within past 10 days
  • Treatment with oral anticoagulation (vitamin K antagonist, dabigatran, apixaban, rivaroxiban) within past 3 days
  • Treatment with a glycoprotein IIb/IIIa inhibitor during PCI
  • Fibrinolytics within 48 hours
  • Known hemoglobin<10 gm/dL
  • Known platelet count <80x106/mL
  • Active bleeding or hemodynamic instability
  • Known end stage renal disease on hemodialysis
  • Known severe hepatic dysfunction

Treatment and study plan

Primary outcomes

  1. Change in platelet reactivity

    Time frame: wiithin 30 min, 1 hour, 2 hours, and 4 hours of blood sampling

    measure of change platelet reactivity at time points

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

Impact of Timing of Pharmacodynamic Assessments on Measures of Platelet Reactivity in Patients Undergoing Percutaneous Coronary Intervention Treated With Cangrelor

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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