NCT04471870

Brief Summary

The Sponsor implemented a post-authorisation safety study (PASS), category 3, focused in Acute Coronary Syndrome, in order to collect information about the safety of cangrelor in the real clinical practice, evaluating the safety of the transition to all the oral P2Y12 inhibitors (cangrelor, ticagrelor and prasugrel).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,005

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

30 active sites

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

July 6, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2022

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

July 6, 2020

Last Update Submit

February 19, 2026

Conditions

Keywords

Real-wordACSPCI

Outcome Measures

Primary Outcomes (1)

  • Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria

    The incidence will be calculated as the ratio between the number of patients experiencing at least one event during the 30-day observation period over the total number of evaluable patients.

    30 days post-PCI

Secondary Outcomes (8)

  • Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

    48 hours after PCI

  • Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

    30 days after PCI

  • Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

    48 hours after PCI

  • Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

    30 days after PCI

  • Incidence of major adverse cardiac events (MACE)

    48 hours after PCI

  • +3 more secondary outcomes

Eligibility Criteria

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

Patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive cangrelor i.v. according to the clinical practice

You may qualify if:

  • Patients' written informed and privacy consent obtained before or at the end of the PCI procedure according to patients' condition but in any case, prior to collection of any study-related data;
  • Male or female patients aged ≥ 18 years;
  • Patients with acute coronary syndromes undergoing PCI;
  • Patients who are planned to be treated with cangrelor, or who have received treatment with cangrelor.

You may not qualify if:

  • Patients with active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension;
  • Patients with history of stroke or transient ischaemic attack (TIA);
  • Patients with hypersensitivity to the active substance (cangrelor) or to any of its excipients;
  • Known pregnancy or breast-feeding female patients;
  • Patients with stable angina (SA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

A.O.U. Riuniti

Ancona, Italy

Location

Ospedale San Donato

Arezzo, Italy

Location

A.O.U. Consorziale Policlinico

Bari, Italy

Location

Ospedale San Bassiano

Bassano del Grappa, Italy

Location

Azienda Ospedaliera San Pio

Benevento, Italy

Location

Ospedale Maggiore

Bologna, Italy

Location

Fondazione Poliambulanza

Brescia, Italy

Location

A.O. Sant'Anna e San Sebastiano

Caserta, Italy

Location

A.O.U. Policlinico-Vittorio Emanuele P.O. Ferrarotto

Catania, Italy

Location

Ospedale SS Annunziata

Cosenza, Italy

Location

ASO Santa Croce e Carle

Cuneo, Italy

Location

A.O.U. Careggi

Florence, Italy

Location

Ospedale Fabrizio Spaziani

Frosinone, Italy

Location

Ospedale S. Andrea

La Spezia, Italy

Location

Ospedale Santa Maria Goretti

Latina, Italy

Location

Fondazione Toscana "G. Monasterio" Ospedale del Cuore G. Pasquinucci

Massa, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

A.O.R.N. A. Cardarelli

Naples, Italy

Location

A.O.U. Federico II

Naples, Italy

Location

A.O. Padova

Padua, Italy

Location

Policlinico San Matteo

Pavia, Italy

Location

Ospedale degli Infermi

Rivoli, Italy

Location

San Camillo Forlanini

Roma, 00152, Italy

Location

Aurelia Hospital

Roma, Italy

Location

Fondazione Policlinico Universitario A. Gemelli

Roma, Italy

Location

A.O.U. Sassari

Sassari, Italy

Location

Ospedale Umberto I

Syracuse, Italy

Location

A.O. Mauriziano

Torino, Italy

Location

Ospedale Santa Chiara

Trento, Italy

Location

Ospedale Ca' Foncello

Treviso, Italy

Location

Related Publications (2)

  • De Luca L, Calabro P, Chirillo F, Rolfo C, Menozzi A, Capranzano P, Menichelli M, Nicolini E, Mauro C, Trani C, Versaci F, Tomai F, Musumeci G, Di Mario C, Pepe M, Berti S, Cernetti C, Cirillo P, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, Scherillo M, Tarantini G, Muraglia S, Rossini R, Bolognese L; ARCANGELO study group. Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study. Clin Cardiol. 2022 Sep;45(9):913-920. doi: 10.1002/clc.23878. Epub 2022 Jun 22.

  • Capranzano P, Calabro P, Musumeci G, Mario CD, Chirillo F, Rolfo C, Menozzi A, Menichelli M, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, De Luca L. Use of Cangrelor in Older Patients: Findings from the itAlian pRospective Study on CANGrELOr Study. Am J Cardiol. 2025 Apr 1;240:31-37. doi: 10.1016/j.amjcard.2024.12.021. Epub 2024 Dec 21.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 15, 2020

Study Start

October 23, 2020

Primary Completion

January 17, 2022

Study Completion

January 17, 2022

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations