ARCANGELO (itAlian pRospective Study on CANGrELOr)

Chiesi

Status: Completed

Conditions: Acute Coronary Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT04471870

DFIDM-1801

Details and patient eligibility

About

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).

Enrollment: 1,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).