<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471870</url>
  </required_header>
  <id_info>
    <org_study_id>DFIDM-1801</org_study_id>
    <nct_id>NCT04471870</nct_id>
  </id_info>
  <brief_title>ARCANGELO (itAlian pRospective Study on CANGrELOr)</brief_title>
  <acronym>ARCANGELO</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiesi Farmaceutici S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiesi Farmaceutici S.p.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Sponsor implemented a post-authorisation safety study (PASS), category 3, focused in&#xD;
      Acute Coronary Syndrome, in order to collect information about the safety of cangrelor in the&#xD;
      real clinical practice, evaluating the safety of the transition to all the oral P2Y12&#xD;
      inhibitors (cangrelor, ticagrelor and prasugrel).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Actual">January 17, 2022</completion_date>
  <primary_completion_date type="Actual">January 17, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria</measure>
    <time_frame>30 days post-PCI</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria</measure>
    <time_frame>48 hours after PCI</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria</measure>
    <time_frame>30 days after PCI</time_frame>
    <description>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]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria</measure>
    <time_frame>48 hours after PCI</time_frame>
    <description>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]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria</measure>
    <time_frame>30 days after PCI</time_frame>
    <description>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]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major adverse cardiac events (MACE)</measure>
    <time_frame>48 hours after PCI</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major adverse cardiac events (MACE)</measure>
    <time_frame>30 days after PCI</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)</measure>
    <time_frame>30 days after PCI</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors</measure>
    <time_frame>30 days after PCI</time_frame>
    <description>It will be calculated the proportion of patients receiving GPIIb/IIIa inhibitors</description>
  </secondary_outcome>
  <enrollment type="Actual">1005</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute coronary syndromes undergoing percutaneous coronary intervention who&#xD;
        receive cangrelor i.v. according to the clinical practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients' written informed and privacy consent obtained before or at the end of the&#xD;
             PCI procedure according to patients' condition but in any case, prior to collection of&#xD;
             any study-related data;&#xD;
&#xD;
          2. Male or female patients aged ≥ 18 years;&#xD;
&#xD;
          3. Patients with acute coronary syndromes undergoing PCI;&#xD;
&#xD;
          4. Patients who are planned to be treated with cangrelor, or who have received treatment&#xD;
             with cangrelor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active bleeding or increased risk of bleeding, because of impaired&#xD;
             haemostasis and/or irreversible coagulation disorders or due to recent major&#xD;
             surgery/trauma or uncontrolled severe hypertension;&#xD;
&#xD;
          2. Patients with history of stroke or transient ischaemic attack (TIA);&#xD;
&#xD;
          3. Patients with hypersensitivity to the active substance (cangrelor) or to any of its&#xD;
             excipients;&#xD;
&#xD;
          4. Known pregnancy or breast-feeding female patients;&#xD;
&#xD;
          5. Patients with stable angina (SA).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>A.O.U. Riuniti</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Donato</name>
      <address>
        <city>Arezzo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Consorziale Policlinico</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Bassiano</name>
      <address>
        <city>Bassano del Grappa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Pio</name>
      <address>
        <city>Benevento</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Poliambulanza</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Sant'Anna e San Sebastiano</name>
      <address>
        <city>Caserta</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico-Vittorio Emanuele P.O. Ferrarotto</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale SS Annunziata</name>
      <address>
        <city>Cosenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASO Santa Croce e Carle</name>
      <address>
        <city>Cuneo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Fabrizio Spaziani</name>
      <address>
        <city>Frosinone</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Andrea</name>
      <address>
        <city>La Spezia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria Goretti</name>
      <address>
        <city>Latina</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana &quot;G. Monasterio&quot; Ospedale del Cuore G. Pasquinucci</name>
      <address>
        <city>Massa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.R.N. A. Cardarelli</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Federico II</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale degli Infermi</name>
      <address>
        <city>Rivoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Camillo Forlanini</name>
      <address>
        <city>Roma</city>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurelia Hospital</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Sassari</name>
      <address>
        <city>Sassari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Umberto I</name>
      <address>
        <city>Siracusa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Mauriziano</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Chiara</name>
      <address>
        <city>Trento</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ca' Foncello</name>
      <address>
        <city>Treviso</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Real-word</keyword>
  <keyword>ACS</keyword>
  <keyword>PCI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471870
org study id: DFIDM-1801
nct id: NCT04471870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
observational model: Cohort
time perspective: Prospective
measure: Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
time frame: 30 days post-PCI
description: 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.
measure: Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
time frame: 48 hours after PCI
description: 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
measure: Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
time frame: 30 days after PCI
description: 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]
measure: Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
time frame: 48 hours after PCI
description: 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]
measure: Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
time frame: 30 days after PCI
description: 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]
measure: Incidence of major adverse cardiac events (MACE)
time frame: 48 hours after PCI
description: 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).
measure: Incidence of major adverse cardiac events (MACE)
time frame: 30 days after PCI
description: 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).
measure: To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)
time frame: 30 days after PCI
description: 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
measure: To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors
time frame: 30 days after PCI
description: It will be calculated the proportion of patients receiving GPIIb/IIIa inhibitors
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Italy
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No