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

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

Detailed Description
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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.

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Cangrelor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cangrelor|All patients receiving Cangrelor during PCI will be enrolled and analyzed for platelet function tests.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cangrelor, Acute coronary syndrome, Chronic coronary syndrome