Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry) (POMPEII)

PharmacOdynaMic Effects of Cangrelor in PatiEnts wIth Acute or chronIc Coronary Syndrome Undergoing Percutaneous Coronary Intervention (POMPEII Registry)

This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Cangrelor

Detailed Description

There is huge interest in achieving fast and immediate antiplatelet effect at the time of PCI, particularly in acute myocardial infarction and Cangrelor is an intravenous antagonist of the P2Y12 receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. However, there are limited pharmacodynamic data exploring the effects of this drug in the various clinical settings at the approved dosages and with current gold standard methods for testing platelet reactivity. More importantly, there are no data on rates and predictors of high residual platelet reactivity (HRPR) in patients treated with cangrelor. Therefore the present study aims at building up a large prospective registry of pharmacodynamic data obtained by light transmittance aggregometry (LTA), multiplate analysis and verifynow system in patients undergoing PCI and receiving cangrelor.

This study is designed as a single-center prospective registry. Investigators at University Hospital of Naples Federico II will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Giuseppe Gargiulo, MD, PhD; Phone Number: +39-0817463075; Email: giuseppe.gargiulo1@unina.it
• Study Contact Backup: Name: Giovanni Esposito, MD, PhD; Phone Number: +39-0817463075; Email: espogiov@unina.it

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • University Federico II of Naples
    • Contact: Giuseppe Gargiulo, MD, PhD; Email: giuseppe.gargiulo1@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Acute (ACS) or Chronic coronary syndrome (CCS) undergoing PCI and receiving cangrelor administration.

Description

Inclusion Criteria:

• All adult patients undergoing PCI and receiving cangrelor administration will be eligible for inclusion in the study.

Exclusion Criteria:

• only those not providing consent to blood/data collection will be excluded.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l	Platelet inhibition assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum platelet aggregation (MPA) with LTA-ADP 20 µmol/l	Platelet aggregation assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop	30 minutes
Rates of High Residual Platelet Reactivity (HRPR) with LTA-ADP 20 µmol/l defined as MPA>59%	High platelet aggregation assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop	30 minutes
Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l	Platelet inhibition assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop	30 minutes
Maximum platelet aggregation (MPA) with LTA-ADP 5 µmol/l	Platelet aggregation assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop	30 minutes
Rates of High Residual Platelet Reactivity with LTA-ADP 5 µmol/l defined as MPA>46%	High platelet aggregation assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop	30 minutes
Area under the curve (AUC) at Multiplate with ADP test	Platelet aggregation assessed with Multiplate ADP test at 30 minutes and after infusion stop	30 minutes
Rates of HRPR defined as Multiplate AUC >46 U	High platelet aggregation assessed with Multiplate ADP test at 30 minutes and after infusion stop	30 minutes
P2Y12 Reaction Unit (PRU) at VerifyNow	Platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop	30 minutes
Rates of HRPR defined as VerifyNow PRU >208	High platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop	30 minutes
Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow	Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow few hours after cangrelor infusion interruption	After stop of cangrelor infusion
Clinical outcomes at 30 days	Ischemic and bleeding outcomes at 30 days	30 day

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Giuseppe Gargiulo, MD, PhD, Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy; Study Chair: Giovanni Esposito, MD, PhD, Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy

Publications and helpful links

General Publications

• Gargiulo G, Esposito G, Avvedimento M, Nagler M, Minuz P, Campo G, Gragnano F, Manavifar N, Piccolo R, Tebaldi M, Cirillo P, Hunziker L, Vranckx P, Leonardi S, Heg D, Windecker S, Valgimigli M. Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial. Circulation. 2020 Aug 4;142(5):441-454. doi: 10.1161/CIRCULATIONAHA.120.046928. Epub 2020 Jun 27. Erratum In: Circulation. 2020 Aug 4;142(5):e71.
• Sibbing D, Aradi D, Alexopoulos D, Ten Berg J, Bhatt DL, Bonello L, Collet JP, Cuisset T, Franchi F, Gross L, Gurbel P, Jeong YH, Mehran R, Moliterno DJ, Neumann FJ, Pereira NL, Price MJ, Sabatine MS, So DYF, Stone GW, Storey RF, Tantry U, Trenk D, Valgimigli M, Waksman R, Angiolillo DJ. Updated Expert Consensus Statement on Platelet Function and Genetic Testing for Guiding P2Y12 Receptor Inhibitor Treatment in Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1521-1537. doi: 10.1016/j.jcin.2019.03.034. Epub 2019 Jun 12.
• Angiolillo DJ, Rollini F, Storey RF, Bhatt DL, James S, Schneider DJ, Sibbing D, So DYF, Trenk D, Alexopoulos D, Gurbel PA, Hochholzer W, De Luca L, Bonello L, Aradi D, Cuisset T, Tantry US, Wang TY, Valgimigli M, Waksman R, Mehran R, Montalescot G, Franchi F, Price MJ. International Expert Consensus on Switching Platelet P2Y12 Receptor-Inhibiting Therapies. Circulation. 2017 Nov 14;136(20):1955-1975. doi: 10.1161/CIRCULATIONAHA.117.031164. Epub 2017 Oct 30.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 6, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Cangrelor; Chronic coronary syndrome
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Cangrelor
• Other Study ID Numbers: POMPEII Registry

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No