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

NCT ID: NCT04790032

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2024-07-01

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.

Conditions

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Percutaneous Coronary Intervention

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Cangrelor

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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Gargiulo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Gargiulo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy

Giovanni Esposito, MD, PhD

Role: STUDY_CHAIR

Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy

Locations

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University Federico II of Naples

Napoli, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 32795098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31202949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29084738 (View on PubMed)

Gargiulo G, Cirillo P, Sperandeo L, Castiello DS, Manzi L, Forzano I, Florimonte D, Simonetti F, Canonico ME, Avvedimento M, Paolillo R, Spinelli A, Buongiorno F, Serafino LD, Spaccarotella CAM, Franzone A, Piccolo R, Stabile E, Valgimigli M, Esposito G. Pharmacodynamic effects of cangrelor in patients with acute or chronic coronary syndrome undergoing percutaneous coronary intervention: the POMPEII Registry. EuroIntervention. 2025 May 16;21(10):560-570. doi: 10.4244/EIJ-D-24-00757.

Reference Type RESULT
PMID: 40375762 (View on PubMed)

Other Identifiers

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POMPEII Registry

Identifier Type: -

Identifier Source: org_study_id

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