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Completed

NCT Number: NCT04471870

ARCANGELO (itAlian pRospective Study on CANGrELOr)

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).

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O.U. Riuniti, Ancona, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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]

  3. 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]

  4. 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]

  5. 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).

  6. 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).

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Acronym: ARCANGELO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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