NCT04790032

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

March 4, 2021

Last Update Submit

August 4, 2025

Conditions

Percutaneous Coronary Intervention

Keywords

CangrelorAcute coronary syndromeChronic coronary syndrome

Outcome Measures

Primary Outcomes (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

    30 minutes

Secondary Outcomes (11)

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

    30 minutes

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

    30 minutes

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

    30 minutes

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

    30 minutes

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

    30 minutes

  • +6 more secondary outcomes

Interventions

CangrelorDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Federico II of Naples

Napoli, 80131, Italy

Location

Related Publications (4)

  • 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.

    PMID: 32795098BACKGROUND

  • 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.

    PMID: 31202949BACKGROUND

  • 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.

    PMID: 29084738BACKGROUND

  • 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.

    PMID: 40375762RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Giuseppe Gargiulo, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Giovanni Esposito, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

March 16, 2021

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)