ARCANGELO (itAlian pRospective Study on CANGrELOr)

Acute Coronary Syndrome Clinical Trial

— ARCANGELO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471870
• Other study ID #: DFIDM-1801
• Status: Completed
• Start date: October 23, 2020
• Est. completion date: January 17, 2022

Study information

• Verified date: March 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1005
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Italy	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	ASO Santa Croce e Carle	Cuneo
Italy	A.O.U. Careggi	Firenze
Italy	Ospedale Fabrizio Spaziani	Frosinone
Italy	Ospedale S. Andrea	La Spezia
Italy	Ospedale Santa Maria Goretti	Latina
Italy	Fondazione Toscana "G. Monasterio" Ospedale del Cuore G. Pasquinucci	Massa
Italy	Centro Cardiologico Monzino	Milano
Italy	A.O.R.N. A. Cardarelli	Napoli
Italy	A.O.U. Federico II	Napoli
Italy	A.O. Padova	Padova
Italy	Policlinico San Matteo	Pavia
Italy	Ospedale degli Infermi	Rivoli
Italy	Aurelia Hospital	Roma
Italy	Fondazione Policlinico Universitario A. Gemelli	Roma
Italy	San Camillo Forlanini	Roma
Italy	A.O.U. Sassari	Sassari
Italy	Ospedale Umberto I	Siracusa
Italy	A.O. Mauriziano	Torino
Italy	Ospedale Santa Chiara	Trento
Italy	Ospedale Ca' Foncello	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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