Clinical trial NCT04471870: ARCANGELO (itAlian pRospective Study on CANGrELOr)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Real-word
ACS
PCI
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 1005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive cangrelor i.v. according to the clinical practice

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
timeFrame: 30 days post-PCI
Secondary outcomes:
measure: Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
timeFrame: 48 hours after PCI
measure: Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
timeFrame: 30 days after PCI
measure: Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
timeFrame: 48 hours after PCI
measure: Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
timeFrame: 30 days after PCI
measure: Incidence of major adverse cardiac events (MACE)
timeFrame: 48 hours after PCI
measure: Incidence of major adverse cardiac events (MACE)
timeFrame: 30 days after PCI
measure: To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)
timeFrame: 30 days after PCI
measure: To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors
timeFrame: 30 days after PCI
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: A.O.U. Riuniti
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Bari
country: Italy
facility: A.O.U. Consorziale Policlinico
city: Bassano del Grappa
country: Italy
facility: Ospedale San Bassiano
city: Benevento
country: Italy
facility: Azienda Ospedaliera San Pio
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Caserta
country: Italy
facility: A.O. Sant'Anna e San Sebastiano
city: Catania
country: Italy
facility: A.O.U. Policlinico-Vittorio Emanuele P.O. Ferrarotto
city: Cosenza
country: Italy
facility: Ospedale SS Annunziata
city: Cuneo
country: Italy
facility: ASO Santa Croce e Carle
city: Firenze
country: Italy
facility: A.O.U. Careggi
city: Frosinone
country: Italy
facility: Ospedale Fabrizio Spaziani
city: La Spezia
country: Italy
facility: Ospedale S. Andrea
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Massa
country: Italy
facility: Fondazione Toscana "G. Monasterio" Ospedale del Cuore G. Pasquinucci
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Napoli
country: Italy
facility: A.O.R.N. A. Cardarelli
city: Napoli
country: Italy
facility: A.O.U. Federico II
city: Padova
country: Italy
facility: A.O. Padova
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Rivoli
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: San Camillo Forlanini
city: Roma
country: Italy
facility: Aurelia Hospital
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Sassari
country: Italy
facility: A.O.U. Sassari
city: Siracusa
country: Italy
facility: Ospedale Umberto I
city: Torino
country: Italy
facility: A.O. Mauriziano
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello
Study officials:
References: