ARCANGELO (itAlian pRospective Study on CANGrELOr)

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT04471870
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Study Start: 2020-10-23
• Primary Completion: 2022-01-17
• Study Completion: 2022-01-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1005

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria	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 \[BARC\]
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria	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 \[BARC\]
Incidence of major adverse cardiac events (MACE)	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).
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

Trial Locations

Locations (30)

A.O.U. Riuniti; 🇮🇹 Ancona, Italy

Ospedale San Donato; 🇮🇹 Arezzo, Italy

A.O.U. Consorziale Policlinico; 🇮🇹 Bari, Italy

Ospedale San Bassiano; 🇮🇹 Bassano del Grappa, Italy

Azienda Ospedaliera San Pio; 🇮🇹 Benevento, Italy

Ospedale Maggiore; 🇮🇹 Bologna, Italy

Fondazione Poliambulanza; 🇮🇹 Brescia, Italy

A.O. Sant'Anna e San Sebastiano; 🇮🇹 Caserta, Italy

A.O.U. Policlinico-Vittorio Emanuele P.O. Ferrarotto; 🇮🇹 Catania, Italy

Ospedale SS Annunziata; 🇮🇹 Cosenza, Italy

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