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Completed

NCT Number: NCT04790032

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

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

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Key information

Conditions

Percutaneous Coronary Intervention Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Federico II of Naples

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cangrelor

Drug

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

Primary outcomes

  1. Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l

    Time frame: 30 minutes

    Platelet inhibition assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop

Secondary outcomes

  1. Maximum platelet aggregation (MPA) with LTA-ADP 20 µmol/l

    Time frame: 30 minutes

    Platelet aggregation assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop

  2. Rates of High Residual Platelet Reactivity (HRPR) with LTA-ADP 20 µmol/l defined as MPA>59%

    Time frame: 30 minutes

    High platelet aggregation assessed with LTA-ADP 20 µmol/l at 30 minutes and after infusion stop

  3. Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l

    Time frame: 30 minutes

    Platelet inhibition assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop

  4. Maximum platelet aggregation (MPA) with LTA-ADP 5 µmol/l

    Time frame: 30 minutes

    Platelet aggregation assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop

  5. Rates of High Residual Platelet Reactivity with LTA-ADP 5 µmol/l defined as MPA>46%

    Time frame: 30 minutes

    High platelet aggregation assessed with LTA-ADP 5 µmol/l at 30 minutes and after infusion stop

  6. Area under the curve (AUC) at Multiplate with ADP test

    Time frame: 30 minutes

    Platelet aggregation assessed with Multiplate ADP test at 30 minutes and after infusion stop

  7. Rates of HRPR defined as Multiplate AUC >46 U

    Time frame: 30 minutes

    High platelet aggregation assessed with Multiplate ADP test at 30 minutes and after infusion stop

  8. P2Y12 Reaction Unit (PRU) at VerifyNow

    Time frame: 30 minutes

    Platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop

  9. Rates of HRPR defined as VerifyNow PRU >208

    Time frame: 30 minutes

    High platelet aggregation assessed with VerifyNow ADP test at 30 minutes and after infusion stop

  10. Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow

    Time frame: After stop of cangrelor infusion

    Platelet aggregation, inhibition and HRPR by LTA, Multiplate and VerifyNow few hours after cangrelor infusion interruption

  11. Clinical outcomes at 30 days

    Time frame: 30 day

    Ischemic and bleeding outcomes at 30 days

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: POMPEII

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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