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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS36393 | Other Identifier | HMA-EMA Real-World Data (RWD) Catalogues |
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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).
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive cangrelor i.v. according to the clinical practice
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. Riuniti | Ancona | Italy | ||||
| Ospedale San Donato |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35733352 | Result | De Luca L, Calabro P, Chirillo F, Rolfo C, Menozzi A, Capranzano P, Menichelli M, Nicolini E, Mauro C, Trani C, Versaci F, Tomai F, Musumeci G, Di Mario C, Pepe M, Berti S, Cernetti C, Cirillo P, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, Scherillo M, Tarantini G, Muraglia S, Rossini R, Bolognese L; ARCANGELO study group. Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study. Clin Cardiol. 2022 Sep;45(9):913-920. doi: 10.1002/clc.23878. Epub 2022 Jun 22. | |
| 39716523 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 |
| 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 | Florence | 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 | Milan | Italy |
| A.O.R.N. A. Cardarelli | Naples | Italy |
| A.O.U. Federico II | Naples | Italy |
| A.O. Padova | Padova | Italy |
| Policlinico San Matteo | Pavia | Italy |
| Ospedale degli Infermi | Rivoli | Italy |
| San Camillo Forlanini | Roma | 00152 | Italy |
| Aurelia Hospital | Roma | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Roma | Italy |
| A.O.U. Sassari | Sassari | Italy |
| Ospedale Umberto I | Syracuse | Italy |
| A.O. Mauriziano | Torino | Italy |
| Ospedale Santa Chiara | Trento | Italy |
| Ospedale Ca' Foncello | Treviso | Italy |
| Derived |
| Capranzano P, Calabro P, Musumeci G, Mario CD, Chirillo F, Rolfo C, Menozzi A, Menichelli M, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, De Luca L. Use of Cangrelor in Older Patients: Findings from the itAlian pRospective Study on CANGrELOr Study. Am J Cardiol. 2025 Apr 1;240:31-37. doi: 10.1016/j.amjcard.2024.12.021. Epub 2024 Dec 21. |