ARCANGELO (itAlian pRospective Study on CANGrELOr)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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] | 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] | 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] | 30 days after PCI | 
| Incidence of major adverse cardiac events (MACE) | 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). | 48 hours after PCI | 
| Incidence of major adverse cardiac events (MACE) | 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). | 30 days after PCI | 
| To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel) | 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 | 30 days after PCI | 
| To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors | It will be calculated the proportion of patients receiving GPIIb/IIIa inhibitors | 30 days after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-word, ACS, PCI