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Percutaneous Coronary InterventionPOMPEIINCT04790032

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

An observational study of Percutaneous Coronary Intervention, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Percutaneous Coronary Intervention
What is being tested?
Cangrelor
How many people
150 participants
Where
1 siteItaly
Study dates
16 Mar 2021to 1 Jul 2024
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with Acute (ACS) or Chronic coronary syndrome (CCS) undergoing PCI and receiving cangrelor administration.

Who may be able to join

  • All adult patients undergoing PCI and receiving cangrelor administration will be eligible for inclusion in the study.

Who cannot join

  • only those not providing consent to blood/data collection will be excluded.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University Federico II of Naples

    Naples, 80131

Other trials in Italy

About this study

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

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

Read the 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.

Being tested
Cangrelor
Keywords
Cangrelor, Acute coronary syndrome, Chronic coronary syndrome
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CangrelorDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 minutes

Secondary outcomes (11)

  1. 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

    Measured: 30 minutes

  2. 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

    Measured: 30 minutes

  3. 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

    Measured: 30 minutes

  4. 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

    Measured: 30 minutes

  5. 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

    Measured: 30 minutes

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

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

    Measured: 30 minutes

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

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

    Measured: 30 minutes

  8. P2Y12 Reaction Unit (PRU) at VerifyNow

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

    Measured: 30 minutes

  9. Rates of HRPR defined as VerifyNow PRU >208

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

    Measured: 30 minutes

  10. 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

    Measured: After stop of cangrelor infusion

  11. Clinical outcomes at 30 days

    Ischemic and bleeding outcomes at 30 days

    Measured: 30 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start16 Mar 2021
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04790032
Sponsor's protocol ID
POMPEII Registry
Acronym
POMPEII
Status last verified
Aug 2025
First submitted
4 Mar 2021
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32795098

  • 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.

    PubMed 31202949

  • 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.

    PubMed 29084738

  • 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.

    PubMed 40375762

Questions about this trial

What is this clinical trial studying?

An observational study of Percutaneous Coronary Intervention, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04790032, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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