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

Percutaneous Coronary Intervention Clinical Trial

— POMPEII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790032
• Other study ID #: POMPEII Registry
• Status: Recruiting
• Start date: March 16, 2021
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Federico II University
• Contact: Giuseppe Gargiulo, MD, PhD
• Phone: +39-0817463075
• Email: giuseppe.gargiulo1[@]unina.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
Italy	University Federico II of Naples	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	P2Y12 Reaction Unit (PRU) at VerifyNow	Platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop	30 minutes
Secondary	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
Secondary	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
Secondary	Clinical outcomes at 30 days	Ischemic and bleeding outcomes at 30 days	30 day