ARCANGELO (itAlian pRospective Study on CANGrELOr)

Chiesi Farmaceutici S.p.A.1,005 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,005

Conditions

Acute Coronary Syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (30)

A.O.U. Riuniti

Ancona, Italy

Outcomes

Primary Outcomes

Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria

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.

Time frame: 30 days post-PCI

Secondary Outcomes

Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

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

Time frame: 48 hours after PCI

Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

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 \[BARC\]

Time frame: 30 days after PCI

Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

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 \[BARC\]

Time frame: 48 hours after PCI

Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria

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 \[BARC\]

Time frame: 30 days after PCI

Data from ClinicalTrials.gov

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