ARCANGELO (itAlian pRospective Study on CANGrELOr) (ARCANGELO)

February 19, 2026 updated by: Chiesi Farmaceutici S.p.A.

Multicentre Observational, Prospective Cohort Study Including Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Who Receive Cangrelor i.v. Transitioning to Clopidogrel, Prasugrel or Ticagrelor Per os

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • A.O.U. Riuniti
      • Arezzo, Italy
        • Ospedale San Donato
      • Bari, Italy
        • A.O.U. Consorziale Policlinico
      • Bassano del Grappa, Italy
        • Ospedale San Bassiano
      • Benevento, Italy
        • Azienda Ospedaliera San Pio
      • Bologna, Italy
        • Ospedale Maggiore
      • Brescia, Italy
        • Fondazione Poliambulanza
      • Caserta, Italy
        • A.O. Sant'Anna e San Sebastiano
      • Catania, Italy
        • A.O.U. Policlinico-Vittorio Emanuele P.O. Ferrarotto
      • Cosenza, Italy
        • Ospedale SS Annunziata
      • Cuneo, Italy
        • ASO Santa Croce e Carle
      • Florence, Italy
        • A.O.U. Careggi
      • Frosinone, Italy
        • Ospedale Fabrizio Spaziani
      • La Spezia, Italy
        • Ospedale S. Andrea
      • Latina, Italy
        • Ospedale Santa Maria Goretti
      • Massa, Italy
        • Fondazione Toscana "G. Monasterio" Ospedale del Cuore G. Pasquinucci
      • Milan, Italy
        • Centro Cardiologico Monzino
      • Napoli, Italy
        • A.O.U. Federico II
      • Napoli, Italy
        • A.O.R.N. A. Cardarelli
      • Padua, Italy
        • A.O. Padova
      • Pavia, Italy
        • Policlinico San Matteo
      • Rivoli, Italy
        • Ospedale Degli Infermi
      • Roma, Italy, 00152
        • San Camillo Forlanini
      • Roma, Italy
        • Aurelia Hospital
      • Roma, Italy
        • Fondazione Policlinico Universitario A. Gemelli
      • Sassari, Italy
        • A.O.U. Sassari
      • Syracuse, Italy
        • Ospedale Umberto I
      • Torino, Italy
        • A.O. Mauriziano
      • Trento, Italy
        • Ospedale Santa Chiara
      • Treviso, Italy
        • Ospedale Ca' Foncello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 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;
  2. Male or female patients aged ≥ 18 years;
  3. Patients with acute coronary syndromes undergoing PCI;
  4. Patients who are planned to be treated with cangrelor, or who have received treatment with cangrelor.

Exclusion Criteria:

  1. 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;
  2. Patients with history of stroke or transient ischaemic attack (TIA);
  3. Patients with hypersensitivity to the active substance (cangrelor) or to any of its excipients;
  4. Known pregnancy or breast-feeding female patients;
  5. Patients with stable angina (SA).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
Time Frame: 30 days post-PCI
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time Frame: 48 hours after PCI
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patients
48 hours after PCI
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time Frame: 30 days after PCI
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patientsConsortium [BARC]
30 days after PCI
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time Frame: 48 hours after PCI
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patientsConsortium [BARC]
48 hours after PCI
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time Frame: 30 days after PCI
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patientsConsortium [BARC] bleedings, according to the Bleeding Academic Research Consortium [BARC]
30 days after PCI
Incidence of major adverse cardiac events (MACE)
Time Frame: 48 hours after PCI
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patients. MACE will comprise any of the following events: death, myocardial infarction (MI), ischemia-driven revascularisation (IDR) and stent thrombosis (ST).
48 hours after PCI
Incidence of major adverse cardiac events (MACE)
Time Frame: 30 days after PCI
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patients. MACE will comprise any of the following events: death, myocardial infarction (MI), ischemia-driven revascularisation (IDR) and stent thrombosis (ST).
30 days after PCI
To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)
Time Frame: 30 days after PCI
It will be calculated the proportion of patients receiving an oral platelet P2Y12 receptor in terms of type (prasugrel/ticagrelor/clopidogrel) and timing of administration
30 days after PCI
To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors
Time Frame: 30 days after PCI
It will be calculated the proportion of patients receiving GPIIb/IIIa inhibitors
30 days after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Actual)

January 17, 2022

Study Completion (Actual)

January 17, 2022

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFIDM-1801
  • EUPAS36393 (Other Identifier: HMA-EMA Real-World Data (RWD) Catalogues)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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