ARCANGELO (itAlian pRospective Study on CANGrELOr)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04471870

Acronym

ARCANGELO

Enrollment

1005

Registered

2020-07-15

Start date

2020-10-23

Completion date

2022-01-17

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Real-word, ACS, PCI

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria	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

Measure	Time frame	Description
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria	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
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria	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 \[BARC\]
Incidence of major adverse cardiac events (MACE)	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).
To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)	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
To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors	30 days after PCI	It will be calculated the proportion of patients receiving GPIIb/IIIa inhibitors

Countries

Italy

Outcome results