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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT04668495
• Lead Sponsor: University of Florida

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-16
• Study Start: 2021-01-28
• Primary Completion: 2021-04-04
• Study Completion: 2021-07-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in platelet reactivity	wiithin 30 min, 1 hour, 2 hours, and 4 hours of blood sampling	measure of change platelet reactivity at time points

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States