<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/NCT02978040</url>
  </required_header>
  <id_info>
    <org_study_id>FABOLUS-FASTER</org_study_id>
    <nct_id>NCT02978040</nct_id>
  </id_info>
  <brief_title>Randomized Comparison of Cangrelor, Tirofiban and Prasugrel in Patients With STEMI Referred for Primary PCI.</brief_title>
  <acronym>FABOLUS-FASTER</acronym>
  <official_title>Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over prasugreL: a mUlticenter Randomized Open-label Trial in patientS With ST-elevation Myocardial inFarction Referred for primAry percutaneouS inTERvention.FABOLUS FASTER Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients&#xD;
      with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time&#xD;
      of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to&#xD;
      tirofiban and to chewed or integer loading dose of prasugrel is unknown.&#xD;
&#xD;
      The purpose of this trial is to assess the inhibition of platelet aggregation with different&#xD;
      regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion,&#xD;
      prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary&#xD;
      PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients&#xD;
      with ST-elevation myocardial infarction (STEMI). Ancillary pharmacological therapy includes&#xD;
      dual antiplatelet therapy with aspirin and an inhibitor of P2Y12 receptor, responsible of&#xD;
      adenosine diphosphate(ADP)-mediated platelet activation.Prasugrel and ticagrelor are the most&#xD;
      recent and efficient oral P2Y12 inhibitors available to date. However, in STEMI even&#xD;
      prasugrel and ticagrelor could have a significant delay of onset of action. Early&#xD;
      in-ambulance administration can increase the inhibition of P2Y12 receptor, however, the&#xD;
      benefits versus risks balance remain uncertain. Recently, small-scale independent studies&#xD;
      suggested that chewed or crushed loading dose of ticagrelor or prasugrel can achieve more&#xD;
      pronounced platelet inhibition compared with standard whole tablets soon after drug&#xD;
      administration. Yet, the delay in platelet inhibition remains considerable even after chewed&#xD;
      or crushed loading dose of newer oral P2Y12 inhibitors and suboptimal modulation of platelet&#xD;
      reactivity at the time of primary intervention may persist. Tirofiban and cangrelor are&#xD;
      intravenous drugs with a more rapid onset and offset of action compared with oral agents.&#xD;
      Both agents have been extensively tested in clinical trials including patients with STEMI.&#xD;
      However, the comparative speed of action of cangrelor as opposed to tirofiban and to chewed&#xD;
      or integer loading dose of prasugrel is unknown. The proposed investigation will have a&#xD;
      prospective, randomized, design in which STEMI patients undergoing primary PCI will be&#xD;
      randomized to receive Cangrelor or Tirofiban or Prasugrel (these patients will be further&#xD;
      randomized to receive chewed or integer tablets). Pharmacodynamic testing will be performed&#xD;
      at several time points to test the investigators' study hypotheses: 1) Cangrelor will have&#xD;
      similar inhibitory effect to Tirofiban (non-inferiority of Cangrelor compared with&#xD;
      Tirofiban); 2) Compared with Prasugrel, Cangrelor and Tirofiban will achieve more prompt and&#xD;
      enhanced platelet inhibitory effects (superiority of both Tirofiban and Cangrelor to integer&#xD;
      Prasugrel); 3) Compared with integer loading dose of Prasugrel, chewed Prasugrel regimen will&#xD;
      achieve more prompt and enhanced platelet inhibitory effects (superiority of chewed Prasugrel&#xD;
      to integer Prasugrel). This study will provide insights on the pharmacodynamic effects of&#xD;
      these drugs and will help clinicians choose the most appropriate treatment to avoid&#xD;
      complications related to inadequate platelet inhibition in the early phase of patients with&#xD;
      STEMI undergoing primary PCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2017</start_date>
  <completion_date type="Actual">December 27, 2019</completion_date>
  <primary_completion_date type="Actual">August 26, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The study is open label. Participant and Investigators will be not masked to randomly assigned treatments. An independent blinded committee will assess clinical adverse events.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l</measure>
    <time_frame>30 minutes</time_frame>
    <description>Primary outcome is platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of adenosine diphosphate (ADP) 20 µmol/l at 30 minutes from drug administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l</measure>
    <time_frame>15 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours</time_frame>
    <description>Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of ADP 20 µmol/l at 15 minutes, 1h, 2h, 3h and 4-6h from drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l</measure>
    <time_frame>15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours</time_frame>
    <description>Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of ADP 5 µmol/l at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of platelet activity (IPA, %) with LTA-TRAP 5 µmol/l</measure>
    <time_frame>15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours</time_frame>
    <description>Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of thrombin receptor-activating peptides (TRAP) 5 µmol/l at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of platelet activity (IPA, %) with LTA-TRAP 15 µmol/l</measure>
    <time_frame>15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours</time_frame>
    <description>Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of TRAP 15 µmol/l at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) at Multiplate with ADP test</measure>
    <time_frame>15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours</time_frame>
    <description>Platelet inhibition assessed with Multiplate ADP test at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) at Multiplate with TRAP test</measure>
    <time_frame>15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours</time_frame>
    <description>Platelet inhibition assessed with Multiplate TRAP test at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic result</measure>
    <time_frame>immediately after PCI procedure</time_frame>
    <description>Final angiographic result evaluated by proportion of patients with TIMI flow&lt;3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic result</measure>
    <time_frame>immediately after PCI procedure and 90 minutes after PCI</time_frame>
    <description>ST resolution at ECG recorded after PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct size at Cardiac Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>3 days and 4-6 months after PCI</time_frame>
    <description>Infarct size assessed at cardiac MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intramyocardial haemorrhage at Cardiac Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>3 days and 4-6 months after PCI</time_frame>
    <description>Intramyocardial haemorrhage assessed at cardiac MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse ischemic clinical events</measure>
    <time_frame>48 h and 30 days after PCI</time_frame>
    <description>Major adverse ischemic clinical events (including death, cardiac death, myocardial infarction, stroke, urgent target vessel revascularization, definite/probable stent thrombosis and their combinations in composite endpoints) will be evaluated 48 hours and 30 days from primary PCI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>48 h and 30 days after PCI</time_frame>
    <description>Bleeding events according to Bleeding Academic Research Consortium (BARC), Thrombolysis in Myocardial Infarction (TIMI), Global Use of Strategies To Open occluded arteries (GUSTO) bleeding scales as well as Net adverse clinical events (NACE; defined as the composite of death, non-fatal myocardial infarction, definite/probable stent thrombosis, non-fatal stroke, and BARC 2, 3, or 5 bleeding) will be evaluated at 48 hours and 30 days from primary PCI</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Cangrelor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cangrelor bolus of 30 µg/Kg followed by infusion at 4 µg/Kg/min for 2 h (or to the end of PCI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tirofiban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tirofiban bolus of 25 µg/Kg bolus followed by infusion at 0.15 µg/Kg/min for 2 h (or to the end of PCI) (infusion rate of 0.075 µg/Kg/min for patients with creatinine clearance &lt; 60 ml/min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prasugrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prasugrel oral integer or chewed at an identical loading dose of 60 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cangrelor</intervention_name>
    <description>Cangrelor will be administered as bolus of 30 µg/Kg followed by infusion at 4 µg/Kg/min for 2 h (or to the end of PCI); at the end of infusion, oral prasugrel at loading dose of 60 mg will be administrated, then 10 mg daily (5 mg daily if body weight &lt; 60 kg or age &gt; 75 years old).</description>
    <arm_group_label>Cangrelor</arm_group_label>
    <other_name>Kengreal</other_name>
    <other_name>Kengrexal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tirofiban</intervention_name>
    <description>Tirofiban will be administrated as 25 µg/Kg bolus followed by infusion at 0.15 µg/Kg/min for 2 h (or to the end of PCI) (infusion rate of 0.075 µg/Kg/min for patients with creatinine clearance &lt; 60 ml/min); at the end of infusion, oral prasugrel at loading dose of 60 mg will be administrated, then 10 mg daily (5 mg daily if body weight &lt; 60 kg or age &gt; 75 years old) .</description>
    <arm_group_label>Tirofiban</arm_group_label>
    <other_name>Aggrastat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prasugrel</intervention_name>
    <description>In the prasugrel arm no intravenous anti-platelet drug will be administered. Patients will be randomized to oral integer prasugrel or chewed oral prasugrel at an identical loading dose of 60 mg, then 10 mg daily (5 mg daily if body weight &lt; 60 kg or age &gt; 75 years old).</description>
    <arm_group_label>Prasugrel</arm_group_label>
    <other_name>Efient</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years old&#xD;
&#xD;
          -  ST-segment elevation myocardial infarction&#xD;
&#xD;
          -  Referred for primary PCI either within 12 h of symptom onset or between 12 and 24 h&#xD;
             after onset with evidence of continuing ischemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unconsciousness&#xD;
&#xD;
          -  Other conditions that make the patient incapable receiving integer loading dose of&#xD;
             prasugrel&#xD;
&#xD;
          -  Any contraindication and/or known hypersensitivity or allergy to aspirin, prasugrel,&#xD;
             intravenous unfractionated heparin, cangrelor, tirofiban&#xD;
&#xD;
          -  Any contraindication to primary PCI&#xD;
&#xD;
          -  Administration of glycoprotein IIb/IIIa inhibitors (GPI) or P2Y12-inhibitors or&#xD;
             cangrelor &lt; 7 days&#xD;
&#xD;
          -  Chronic dialysis&#xD;
&#xD;
          -  Recent (&lt; 15 days) or current major bleeding&#xD;
&#xD;
          -  Recent (&lt; 15 days) major surgery&#xD;
&#xD;
          -  Administration of fibrinolytics &lt; 30 days&#xD;
&#xD;
          -  Current use or indication to oral anticoagulant&#xD;
&#xD;
          -  Previous stroke or transient ischemic attack (TIA)&#xD;
&#xD;
          -  Inability to follow the procedures of the study (language problems, psychological&#xD;
             disorders, dementia) or comorbidities associated with less than 6 months survival&#xD;
             (active malignancies drug or alcohol abuse, etc.)&#xD;
&#xD;
          -  Women who are pregnant or breast feeding or with potential to become pregnant during&#xD;
             the course of the study (age &lt; 55 years and last menstruation within the last 12&#xD;
             months) and did not undergo tubal ligation, ovariectomy or hysterectomy&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Valgimigli, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Cardiology, Bern University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giuseppe Gargiulo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Bern University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ferrara</name>
      <address>
        <city>Ferrara</city>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Naples Federico II</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antiplatelet therapy</keyword>
  <keyword>Cangrelor</keyword>
  <keyword>Tirofiban</keyword>
  <keyword>Prasugrel</keyword>
  <keyword>Acute Myocardial Infarction</keyword>
  <keyword>Primary Percutaneous Coronary Intervention</keyword>
  <keyword>Pharmacokinetic/Pharmacodynamic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tirofiban</mesh_term>
    <mesh_term>Prasugrel Hydrochloride</mesh_term>
    <mesh_term>Cangrelor</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02978040
org study id: FABOLUS-FASTER
nct id: NCT02978040
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients
      with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time
      of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to
      tirofiban and to chewed or integer loading dose of prasugrel is unknown.

      The purpose of this trial is to assess the inhibition of platelet aggregation with different
      regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion,
      prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary
      PCI.
Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients
      with ST-elevation myocardial infarction (STEMI). Ancillary pharmacological therapy includes
      dual antiplatelet therapy with aspirin and an inhibitor of P2Y12 receptor, responsible of
      adenosine diphosphate(ADP)-mediated platelet activation.Prasugrel and ticagrelor are the most
      recent and efficient oral P2Y12 inhibitors available to date. However, in STEMI even
      prasugrel and ticagrelor could have a significant delay of onset of action. Early
      in-ambulance administration can increase the inhibition of P2Y12 receptor, however, the
      benefits versus risks balance remain uncertain. Recently, small-scale independent studies
      suggested that chewed or crushed loading dose of ticagrelor or prasugrel can achieve more
      pronounced platelet inhibition compared with standard whole tablets soon after drug
      administration. Yet, the delay in platelet inhibition remains considerable even after chewed
      or crushed loading dose of newer oral P2Y12 inhibitors and suboptimal modulation of platelet
      reactivity at the time of primary intervention may persist. Tirofiban and cangrelor are
      intravenous drugs with a more rapid onset and offset of action compared with oral agents.
      Both agents have been extensively tested in clinical trials including patients with STEMI.
      However, the comparative speed of action of cangrelor as opposed to tirofiban and to chewed
      or integer loading dose of prasugrel is unknown. The proposed investigation will have a
      prospective, randomized, design in which STEMI patients undergoing primary PCI will be
      randomized to receive Cangrelor or Tirofiban or Prasugrel (these patients will be further
      randomized to receive chewed or integer tablets). Pharmacodynamic testing will be performed
      at several time points to test the investigators' study hypotheses: 1) Cangrelor will have
      similar inhibitory effect to Tirofiban (non-inferiority of Cangrelor compared with
      Tirofiban); 2) Compared with Prasugrel, Cangrelor and Tirofiban will achieve more prompt and
      enhanced platelet inhibitory effects (superiority of both Tirofiban and Cangrelor to integer
      Prasugrel); 3) Compared with integer loading dose of Prasugrel, chewed Prasugrel regimen will
      achieve more prompt and enhanced platelet inhibitory effects (superiority of chewed Prasugrel
      to integer Prasugrel). This study will provide insights on the pharmacodynamic effects of
      these drugs and will help clinicians choose the most appropriate treatment to avoid
      complications related to inadequate platelet inhibition in the early phase of patients with
      STEMI undergoing primary PCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The study is open label. Participant and Investigators will be not masked to randomly assigned treatments. An independent blinded committee will assess clinical adverse events.
measure: Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l
time frame: 30 minutes
description: Primary outcome is platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of adenosine diphosphate (ADP) 20 µmol/l at 30 minutes from drug administration
measure: Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l
time frame: 15 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours
description: Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of ADP 20 µmol/l at 15 minutes, 1h, 2h, 3h and 4-6h from drug administration
measure: Inhibition of platelet activity (IPA, %) with LTA-ADP 5 µmol/l
time frame: 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours
description: Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of ADP 5 µmol/l at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration
measure: Inhibition of platelet activity (IPA, %) with LTA-TRAP 5 µmol/l
time frame: 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours
description: Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of thrombin receptor-activating peptides (TRAP) 5 µmol/l at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration
measure: Inhibition of platelet activity (IPA, %) with LTA-TRAP 15 µmol/l
time frame: 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours
description: Platelet inhibition assessed with light transmission aggregometry (LTA) in platelet rich plasma with the addition of TRAP 15 µmol/l at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration
measure: Area under the curve (AUC) at Multiplate with ADP test
time frame: 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours
description: Platelet inhibition assessed with Multiplate ADP test at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration
measure: Area under the curve (AUC) at Multiplate with TRAP test
time frame: 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4-6 hours
description: Platelet inhibition assessed with Multiplate TRAP test at 15 minutes, 30 minutes, 1h, 2h, 3h and 4-6h from drug administration
measure: Angiographic result
time frame: immediately after PCI procedure
description: Final angiographic result evaluated by proportion of patients with TIMI flow<3
measure: Electrocardiographic result
time frame: immediately after PCI procedure and 90 minutes after PCI
description: ST resolution at ECG recorded after PCI
measure: Infarct size at Cardiac Magnetic Resonance Imaging (MRI)
time frame: 3 days and 4-6 months after PCI
description: Infarct size assessed at cardiac MRI
measure: Intramyocardial haemorrhage at Cardiac Magnetic Resonance Imaging (MRI)
time frame: 3 days and 4-6 months after PCI
description: Intramyocardial haemorrhage assessed at cardiac MRI
measure: Major adverse ischemic clinical events
time frame: 48 h and 30 days after PCI
description: Major adverse ischemic clinical events (including death, cardiac death, myocardial infarction, stroke, urgent target vessel revascularization, definite/probable stent thrombosis and their combinations in composite endpoints) will be evaluated 48 hours and 30 days from primary PCI.
measure: Bleeding events
time frame: 48 h and 30 days after PCI
description: Bleeding events according to Bleeding Academic Research Consortium (BARC), Thrombolysis in Myocardial Infarction (TIMI), Global Use of Strategies To Open occluded arteries (GUSTO) bleeding scales as well as Net adverse clinical events (NACE; defined as the composite of death, non-fatal myocardial infarction, definite/probable stent thrombosis, non-fatal stroke, and BARC 2, 3, or 5 bleeding) will be evaluated at 48 hours and 30 days from primary PCI
arm group label: Cangrelor
arm group type: Experimental
description: Cangrelor bolus of 30 µg/Kg followed by infusion at 4 µg/Kg/min for 2 h (or to the end of PCI).
arm group label: Tirofiban
arm group type: Active Comparator
description: Tirofiban bolus of 25 µg/Kg bolus followed by infusion at 0.15 µg/Kg/min for 2 h (or to the end of PCI) (infusion rate of 0.075 µg/Kg/min for patients with creatinine clearance < 60 ml/min).
arm group label: Prasugrel
arm group type: Active Comparator
description: Prasugrel oral integer or chewed at an identical loading dose of 60 mg
intervention type: Drug
intervention name: Cangrelor
description: Cangrelor will be administered as bolus of 30 µg/Kg followed by infusion at 4 µg/Kg/min for 2 h (or to the end of PCI); at the end of infusion, oral prasugrel at loading dose of 60 mg will be administrated, then 10 mg daily (5 mg daily if body weight < 60 kg or age > 75 years old).
arm group label: Cangrelor
other name: Kengreal
other name: Kengrexal
intervention type: Drug
intervention name: Tirofiban
description: Tirofiban will be administrated as 25 µg/Kg bolus followed by infusion at 0.15 µg/Kg/min for 2 h (or to the end of PCI) (infusion rate of 0.075 µg/Kg/min for patients with creatinine clearance < 60 ml/min); at the end of infusion, oral prasugrel at loading dose of 60 mg will be administrated, then 10 mg daily (5 mg daily if body weight < 60 kg or age > 75 years old) .
arm group label: Tirofiban
other name: Aggrastat
intervention type: Drug
intervention name: Prasugrel
description: In the prasugrel arm no intravenous anti-platelet drug will be administered. Patients will be randomized to oral integer prasugrel or chewed oral prasugrel at an identical loading dose of 60 mg, then 10 mg daily (5 mg daily if body weight < 60 kg or age > 75 years old).
arm group label: Prasugrel
other name: Efient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Valgimigli, Prof
role: Study Chair
affiliation: Department of Cardiology, Bern University Hospital
last name: Giuseppe Gargiulo, MD
role: Principal Investigator
affiliation: Department of Cardiology, Bern University Hospital
facility: 
facility: 
facility: 
country: Italy
country: Switzerland
country: France
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Tirofiban
mesh term: Prasugrel Hydrochloride
mesh term: Cangrelor