Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
Study Details
Study Description
Brief Summary
This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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 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
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Federico II of Naples | Napoli | Italy | 80131 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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 P2Y(12) Receptor-Inhibiting Therapies. Circulation. 2017 Nov 14;136(20):1955-1975. doi: 10.1161/CIRCULATIONAHA.117.031164. Epub 2017 Oct 30. Review.
- 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 P2Y(12) 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. Review.
- POMPEII Registry