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

Impact of Timing of Pharmacodynamic Assessments on Measures of Platelet Reactivity in Patients Undergoing Percutaneous Coronary Intervention 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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing percutaneous coronary intervention (PCI) and have been treated with cangrelor per standard of care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cangrelor Group; This is the study cohort that the blood sample will be obtained from. There are no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in platelet reactivity	measure of change platelet reactivity at time points	wiithin 30 min, 1 hour, 2 hours, and 4 hours of blood sampling

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Dominick Angiolillo, MD, PhD, Professor of Medicine

Publications and helpful links

General Publications

• Franchi F, Rollini F, Galli M, Been L, Ghanem G, Shalhoub A, Rivas A, Zhou X, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Bass TA, Angiolillo DJ. Impact of Timing of Pharmacodynamic Assessment on Platelet Reactivity in Patients Treated With Cangrelor. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2410-2412. doi: 10.1016/j.jcin.2021.07.051. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2021
• Primary Completion (ACTUAL): April 4, 2021
• Study Completion (ACTUAL): July 20, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (ACTUAL): December 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Cangrelor Timing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No