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

Conditions

Percutaneous Coronary Intervention

Keywords

Cangrelor, Acute coronary syndrome, Chronic coronary syndrome

Brief summary

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

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.

Gargiulo G, Narciso V, Forzano I, Sperandeo L, Castiello DS, Simonetti F, Manzi L, Florimonte D, Canonico ME, Avvedimento M, Paolillo R, Spinelli A, Di Serafino L, Spaccarotella CAM, Franzone A, Piccolo R, Stabile E, Cirillo P, Valgimigli M, Esposito G.

2026-04-15

10.1093/ehjacc/zuag056

Pharmacodynamic effects of cangrelor in patients with acute or chronic coronary syndrome undergoing percutaneous coronary intervention: the POMPEII Registry.

Gargiulo G, Cirillo P, Sperandeo L, Castiello DS, Manzi L, Forzano I, Florimonte D, Simonetti F, Canonico ME, Avvedimento M, Paolillo R, Spinelli A, Buongiorno F, Serafino LD, Spaccarotella CAM, Franzone A, Piccolo R, Stabile E, Valgimigli M, Esposito G.

2025-05-015 citations

10.4244/eij-d-24-00757

Cangrelor in contemporary patients with ST-segment elevation myocardial infarction pretreated with Ticagrelor: Pharmacodynamic data from the POMPEII study.

Gargiulo G, Cirillo P, Sperandeo L, Forzano I, Castiello DS, Florimonte D, Simonetti F, Paolillo R, Manzi L, Spinelli A, Spaccarotella CAM, Piccolo R, Di Serafino L, Franzone A, Capranzano P, Valgimigli M, Esposito G.

2024-01-235 citations

10.1016/j.ijcha.2024.101344

Pharmacodynamic effects of cangrelor in elective complex PCI: insights from the POMPEII Registry.

Giuseppe Gargiulo, Alessandra Marenna, Luca Sperandeo, Lina Manzi, Marisa Avvedimento et al. (17 authors)

PubMed2023-03-2016 citations

10.4244/eij-d-22-00594

351 MULTIPLE PHARMACODYNAMIC ASSESSMENTS OF CANGRELOR EFFECTS IN ELECTIVE COMPLEX PCI: DATA FROM PHARMACODYNAMIC EFFECTS OF CANGRELOR IN PATIENTS WITH ACUTE OR CHRONIC CORONARY SYNDROME UNDERGOING PERCUTANEOUS CORONARY INTERVENTION REGISTRY

Luca Sperandeo, Alessandra Marenna, Lina Manzi, Marisa Avvedimento, Fiorenzo Simonetti et al. (17 authors)

European Heart Journal Supplements2022-12-14

10.1093/eurheartjsupp/suac121.548

Interventions

DRUGCangrelor

All patients receiving Cangrelor during PCI will be enrolled and analyzed for platelet function tests.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed