Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
- Conditions
- Percutaneous Coronary Intervention
- Registration Number
- NCT04790032
- Lead Sponsor
- Federico II University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- All adult patients undergoing PCI and receiving cangrelor administration will be eligible for inclusion in the study.
- only those not providing consent to blood/data collection will be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
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
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
P2Y12 Reaction Unit (PRU) at VerifyNow 30 minutes Platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop
Clinical outcomes at 30 days 30 day Ischemic and bleeding outcomes at 30 days
Trial Locations
- Locations (1)
University Federico II of Naples
🇮🇹Napoli, Italy