Clinical trial NCT04790032: Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
Official title: PharmacOdynaMic Effects of Cangrelor in PatiEnts wIth Acute or chronIc Coronary Syndrome Undergoing Percutaneous Coronary Intervention (POMPEII Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Percutaneous Coronary Intervention
Keywords: Cangrelor
Acute coronary syndrome
Chronic coronary syndrome
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Acute (ACS) or Chronic coronary syndrome (CCS) undergoing PCI and receiving cangrelor administration.

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.

Eligibility 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.

Primary outcomes:
measure: Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l
timeFrame: 30 minutes
Secondary outcomes:
measure: Maximum platelet aggregation (MPA) with LTA-ADP 20 µmol/l
timeFrame: 30 minutes
measure: Rates of High Residual Platelet Reactivity (HRPR) with LTA-ADP 20 µmol/l defined as MPA>59%
timeFrame: 30 minutes
measure: Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l
timeFrame: 30 minutes
measure: Maximum platelet aggregation (MPA) with LTA-ADP 5 µmol/l
timeFrame: 30 minutes
measure: Rates of High Residual Platelet Reactivity with LTA-ADP 5 µmol/l defined as MPA>46%
timeFrame: 30 minutes
measure: Area under the curve (AUC) at Multiplate with ADP test
timeFrame: 30 minutes
measure: Rates of HRPR defined as Multiplate AUC >46 U
timeFrame: 30 minutes
measure: P2Y12 Reaction Unit (PRU) at VerifyNow
timeFrame: 30 minutes
measure: Rates of HRPR defined as VerifyNow PRU >208
timeFrame: 30 minutes
measure: Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow
timeFrame: After stop of cangrelor infusion
measure: Clinical outcomes at 30 days
timeFrame: 30 day
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University Federico II of Naples
Study officials:
affiliation: Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy
name: Giuseppe Gargiulo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy
name: Giovanni Esposito, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.