ARCANGELO (itAlian pRospective Study on CANGrELOr)

Study Identifier:
DFIDM-1801
ClinicalTrials.gov Identifier:
NCT04471870
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
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Study Details

Medical Condition
  • Thrombosis
Study Drug
    Date
    Oct 2020 - Jan 2022
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • 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.
    Exclusion Criteria
    • 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).
    Healthy Volunteers
    No

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    A.O.U. Riuniti
    Ancona, Italy
    Status
    N/A
    Location
    Ospedale San Donato
    Arezzo, Italy
    Status
    N/A
    Location
    A.O.U. Consorziale Policlinico
    Bari, Italy
    Status
    N/A
    Location
    Ospedale San Bassiano
    Bassano del Grappa, Italy
    Status
    N/A
    Location
    Azienda Ospedaliera San Pio
    Benevento, Italy
    Status
    N/A
    Location
    Ospedale Maggiore
    Bologna, Italy
    Status
    N/A
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    Study Publications

    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.