<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/NCT03023020</url>
  </required_header>
  <id_info>
    <org_study_id>ECRI-009</org_study_id>
    <nct_id>NCT03023020</nct_id>
  </id_info>
  <brief_title>Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen</brief_title>
  <acronym>MASTER DAPT</acronym>
  <official_title>Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ECRI bv</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardialysis B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Cardiovascular Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Terumo Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ECRI bv</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compares two lengths of medication therapy (a shortened versus a prolonged dual&#xD;
      antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the&#xD;
      successfully treatment for coronary heart disease with a drug covered stent (metallic tube).&#xD;
&#xD;
      This comparison will be done in patients who, compared to the average patient, are more&#xD;
      likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are&#xD;
      within the current medical recommendations. The aim of this study is to help improve further&#xD;
      standard antiplatelet duration guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objective is to determine in a high bleeding risk patient population undergoing PCI&#xD;
      under standardized treatment (within current guidelines and instructions for use and&#xD;
      including the bioresorbable polymer coated Ultimaster sirolimus-eluting stent), whether&#xD;
      abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of NACE within 12 months,&#xD;
      whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of MACCE within&#xD;
      12 months and whether abbreviated DAPT is superior to prolonged DAPT regimen in terms of MCB&#xD;
      within 12 months.&#xD;
&#xD;
      There are two treatment strategies:&#xD;
&#xD;
        -  abbreviated dual anti-platelet therapy: dual antiplatelet therapy is discontinued and a&#xD;
           single antiplatelet agent is continued until at least 11 months post randomization (i.e.&#xD;
           12 months post stent implantation). In patients on oral anticoagulants, dual&#xD;
           antiplatelet therapy is discontinued and either Aspirin or Clopidogrel is continued&#xD;
           until 5 months post randomization (i.e. 6 months post stent implantation). Oral&#xD;
           anticoagulation is continued until at least 11 months post randomization (i.e. 12 months&#xD;
           post stent implantation) OR&#xD;
&#xD;
        -  prolonged dual anti-platelet therapy: aspirin is continued for at least 11 months post&#xD;
           randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken&#xD;
           at the time of randomization is continued for at least 5 months and up to 11 months post&#xD;
           randomization (i.e. 12 months post stent implantation). In patients on oral&#xD;
           anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post&#xD;
           randomization (i.e. 3 months post stent implantation) and up to 11 months post&#xD;
           randomization (i.e. 12 months after stent implantation). Therefore either aspirin or&#xD;
           Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent&#xD;
           implantation)&#xD;
&#xD;
      The study design is an investigator-initiated, randomized, multi-center, clinical trial to be&#xD;
      conducted in approximately 100 interventional cardiology centers in across the globe&#xD;
      excluding USA. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will&#xD;
      occur at one month after the PCI procedure. The expected duration of participation for each&#xD;
      patient is 14 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5</measure>
    <time_frame>11 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke</measure>
    <time_frame>11 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events</measure>
    <time_frame>11 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause death</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiovascular causes</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Definite or probable stent thrombosis</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any target vessel revascularization</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urgent target vessel revascularization</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urgent non-target vessel revascularization</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically indicated non-target vessel revascularization</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion rates both in patients with and/or without clinically detected over bleeding</measure>
    <time_frame>14 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4579</enrollment>
  <condition>High Bleeding Risk</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>PCI</condition>
  <arm_group>
    <arm_group_label>Abbreviated antiplatelet regimen</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation).&#xD;
In patients on oral anticoagulants, dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prolonged antiplatelet regimen</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation).&#xD;
In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Dosing per current guidelines and local practice</description>
    <arm_group_label>Abbreviated antiplatelet regimen</arm_group_label>
    <arm_group_label>Prolonged antiplatelet regimen</arm_group_label>
    <other_name>antiplatelet agent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P2Y12 inhibitor</intervention_name>
    <description>Dosing per current guidelines and local practice</description>
    <arm_group_label>Abbreviated antiplatelet regimen</arm_group_label>
    <arm_group_label>Prolonged antiplatelet regimen</arm_group_label>
    <other_name>antiplatelet agent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        After index PCI, patients aged 18 years or more are eligible for inclusion into the study&#xD;
        if the following criteria are met.&#xD;
&#xD;
          1. At least one among the HBR criteria (as defined below) is met.&#xD;
&#xD;
          2. All lesions are successfully treated with Ultimaster stent in the context of routine&#xD;
             clinical care, i.e. post-procedural angiographic diameter stenosis &lt;20% by visual&#xD;
             estimation&#xD;
&#xD;
          3. Free from any flow-limiting angiographic complications (i.e. significant untreated&#xD;
             dissection or major side-branch occlusion), which require prolonged DAPT duration&#xD;
             based on operator's opinion.&#xD;
&#xD;
          4. All stages of PCI are complete (if any) and no further PCI is planned.&#xD;
&#xD;
        At randomization visit (one month after index PCI), the following criteria must be met:&#xD;
&#xD;
          1. Fulfilment of at least one HBR criterion (as defined below), or on the basis of&#xD;
             post-PCI actionable (i.e. requiring medical attention) non-access site related&#xD;
             bleeding episode&#xD;
&#xD;
          2. Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic&#xD;
             restenosis, stent thrombosis, stroke and any revascularization (coronary and&#xD;
             non-coronary) requiring prolonged DAPT&#xD;
&#xD;
          3. If not on OAC,&#xD;
&#xD;
               1. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor&#xD;
&#xD;
               2. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching&#xD;
                  between oral P2Y12 inhibitors has occurred in the previous 7 days)&#xD;
&#xD;
          4. If on OAC&#xD;
&#xD;
               1. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at&#xD;
                  least 7 days&#xD;
&#xD;
               2. Patient is on clopidogrel for at least 7 days&#xD;
&#xD;
        Definition of HBR&#xD;
&#xD;
        Post-PCI patients are at HBR if at least one of the following criteria applies:&#xD;
&#xD;
          -  Clinical indication for treatment with oral anticoagulants (OAC) for at least 12&#xD;
             months&#xD;
&#xD;
          -  Recent (&lt;12 months) non-access site bleeding episode(s), which required medical&#xD;
             attention (i.e. actionable bleeding).&#xD;
&#xD;
          -  Previous bleeding episode(s) which required hospitalization if the underlying cause&#xD;
             has not been definitively treated (i.e. surgical removal of the bleeding source)&#xD;
&#xD;
          -  Age equal or greater than 75 years&#xD;
&#xD;
          -  Systemic conditions associated with an increased bleeding risk (e.g. haematological&#xD;
             disorders, including a history of or current thrombocytopaenia defined as a platelet&#xD;
             count &lt;100,000/mm3 (&lt;100 x 109/L), or any known coagulation disorder associated with&#xD;
             increased bleeding risk.&#xD;
&#xD;
          -  Documented anaemia defined as repeated haemoglobin levels &lt;11 g/dl or transfusion&#xD;
             within 4 weeks before randomization.&#xD;
&#xD;
          -  Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Diagnosed malignancy (other than skin) considered at high bleeding risk including&#xD;
             gastro-intestinal, genito-urethral/renal and pulmonary.&#xD;
&#xD;
          -  Stroke at any time or TIA in the previous 6 months&#xD;
&#xD;
          -  PRECISE DAPT score of 25 or greater&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treated with stents other than Ultimaster stent within 6 months prior to index&#xD;
             procedure&#xD;
&#xD;
          2. Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months&#xD;
             before&#xD;
&#xD;
          3. Treated with a bioresorbable scaffold at any time prior to index procedure&#xD;
&#xD;
          4. Cannot provide written informed consent&#xD;
&#xD;
          5. Under judicial protection, tutorship or curatorship&#xD;
&#xD;
          6. Unable to understand and follow study-related instructions or unable to comply with&#xD;
             study protocol&#xD;
&#xD;
          7. Active bleeding requiring medical attention (BARC≥2) on randomization visit&#xD;
&#xD;
          8. Life expectancy less than one year&#xD;
&#xD;
          9. Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel,&#xD;
             cobalt chromium or sirolimus&#xD;
&#xD;
         10. Any planned and anticipated PCI&#xD;
&#xD;
         11. Participation in another trial&#xD;
&#xD;
         12. Pregnant or breast feeding women&#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>M. Valgimigli, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiocentro Ticino Foundation, Lugano, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>P. Smits, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maasstad Ziekenhuis Rotterdam, The Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>E. Spitzer, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>ECRI bv</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Buenos Aires Research center</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interventional Cardiology Sanatorio</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Melbourne</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Perth</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Sydney</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wollongong Research Center</name>
      <address>
        <city>Wollongong</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center , 043-02</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center, 043-01</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Manama</name>
      <address>
        <city>Manama</city>
        <country>Bahrain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dhaka Research Center</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Aalst</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Bonheiden</name>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU st.Pierre</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Charleroi</name>
      <address>
        <city>Charleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Hasselt</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Liège</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Sveta Karidad Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sofia Resaerch Center, 359-02</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sofia Research Center, 359-01</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sofia Research Center, 359-03</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Brno</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Phraha</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Roskilde</name>
      <address>
        <city>Roskilde</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Tallinn</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Annecy</name>
      <address>
        <city>Annecy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Prive Saint Martin</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Créteil</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Massy</name>
      <address>
        <city>Massy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Mercy</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Montauban</name>
      <address>
        <city>Montauban</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Paris, 033-05</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Paris, 033-06</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Saint-Denis</name>
      <address>
        <city>Saint-Denis</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saarland University</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Clinic</name>
      <address>
        <city>Landshut</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Budapest</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Szeged</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Chennai, 091-01</name>
      <address>
        <city>Chennai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Chennai, 091-05</name>
      <address>
        <city>Chennai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Coimbatore</name>
      <address>
        <city>Coimbatore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Surat</name>
      <address>
        <city>Sūrat</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Haifa</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Jerusalem</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin MC</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Safed</name>
      <address>
        <city>Safed</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Lorenzo Bonomo</name>
      <address>
        <city>Andria</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Brotzu</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second university of Naples Monaldi Hospital</name>
      <address>
        <city>Caserta</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Catania</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico Gaetano Martino</name>
      <address>
        <city>Messina</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niguarda</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Milan, 039-01</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Milan, 039-04</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Milan, 039-11</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Donato Hospital</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sandro Pertini</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Casilino</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Rozzano</name>
      <address>
        <city>Rozzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Cardiology</name>
      <address>
        <city>Treviglio</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Vimercate</name>
      <address>
        <city>Vimercate</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kokura Memorial Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Gifu</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ichinomiya Municipal Hospital</name>
      <address>
        <city>Ichinomiya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Marianna University School of Medicine</name>
      <address>
        <city>Kawasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Medical University Hospital</name>
      <address>
        <city>Nagakute</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Red Cross Nagoya Daiichi Hospital (1st)</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Red Cross Nagoya Daini Hospital (2nd)</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka police Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Luke's International Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Toyoake</name>
      <address>
        <city>Toyoake</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Seoul</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Den Bosch</name>
      <address>
        <city>'s Hertogenbosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Arnhem</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Breda</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Dordrecht</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Emmen</name>
      <address>
        <city>Emmen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Enschede</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antonius ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Terneuzen</name>
      <address>
        <city>Terneuzen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haga Hospital</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Skopje</name>
      <address>
        <city>Skopje</city>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Krakow</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Krakow</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miedziowe Centrum Zdrowia SA</name>
      <address>
        <city>Lubin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Poznan</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Wroclaw</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Jeddah</name>
      <address>
        <city>Jeddah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Riyadh</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Researcg Center Belgrade, 381-02</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center of Serbia, 381-01</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Sremska Kamenica</name>
      <address>
        <city>Sremska Kamenica</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore Research Center</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ljubljana Research Center</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Alicante</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Barcelona, 034-07</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Barcelona, 034-09</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Huelva</name>
      <address>
        <city>Huelva</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de hierro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Madrid, 034-06</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Madrid, 034-10</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Valdecilla</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Vigo</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Gavle</name>
      <address>
        <city>Gävle</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Orebro</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindenhofspital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Fribourg</name>
      <address>
        <city>Fribourg</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Geneva</name>
      <address>
        <city>Geneva</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Liestal</name>
      <address>
        <city>Liestal</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Lugano</name>
      <address>
        <city>Lugano</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Zürich</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Blackburn</name>
      <address>
        <city>Blackburn</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Bournemouth</name>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Brighton</name>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Heart Institute</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altnagelvin Hospital</name>
      <address>
        <city>Derry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester Research Center</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Newcastle</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center Stevenage</name>
      <address>
        <city>Stevenage</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Stoke-on-Trent</name>
      <address>
        <city>Stoke-on-Trent</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Wolverhampton</name>
      <address>
        <city>Wolverhampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centre Worcester</name>
      <address>
        <city>Worcester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vietnam National Heart Institute</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Bahrain</country>
    <country>Bangladesh</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>North Macedonia</country>
    <country>Poland</country>
    <country>Saudi Arabia</country>
    <country>Serbia</country>
    <country>Singapore</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Macedonia, The Former Yugoslav Republic of</country>
  </removed_countries>
  <reference>
    <citation>Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.</citation>
    <PMID>25173339</PMID>
  </reference>
  <reference>
    <citation>Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.</citation>
    <PMID>26320110</PMID>
  </reference>
  <reference>
    <citation>Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016</citation>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>August 19, 2021</last_update_submitted>
  <last_update_submitted_qc>August 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dual Antiplatelet Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Platelet Aggregation Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03023020
org study id: ECRI-009
nct id: NCT03023020
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study compares two lengths of medication therapy (a shortened versus a prolonged dual
      antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the
      successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

      This comparison will be done in patients who, compared to the average patient, are more
      likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are
      within the current medical recommendations. The aim of this study is to help improve further
      standard antiplatelet duration guidelines.
The study objective is to determine in a high bleeding risk patient population undergoing PCI
      under standardized treatment (within current guidelines and instructions for use and
      including the bioresorbable polymer coated Ultimaster sirolimus-eluting stent), whether
      abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of NACE within 12 months,
      whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of MACCE within
      12 months and whether abbreviated DAPT is superior to prolonged DAPT regimen in terms of MCB
      within 12 months.

      There are two treatment strategies:

        -  abbreviated dual anti-platelet therapy: dual antiplatelet therapy is discontinued and a
           single antiplatelet agent is continued until at least 11 months post randomization (i.e.
           12 months post stent implantation). In patients on oral anticoagulants, dual
           antiplatelet therapy is discontinued and either Aspirin or Clopidogrel is continued
           until 5 months post randomization (i.e. 6 months post stent implantation). Oral
           anticoagulation is continued until at least 11 months post randomization (i.e. 12 months
           post stent implantation) OR

        -  prolonged dual anti-platelet therapy: aspirin is continued for at least 11 months post
           randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken
           at the time of randomization is continued for at least 5 months and up to 11 months post
           randomization (i.e. 12 months post stent implantation). In patients on oral
           anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post
           randomization (i.e. 3 months post stent implantation) and up to 11 months post
           randomization (i.e. 12 months after stent implantation). Therefore either aspirin or
           Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent
           implantation)

      The study design is an investigator-initiated, randomized, multi-center, clinical trial to be
      conducted in approximately 100 interventional cardiology centers in across the globe
      excluding USA. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will
      occur at one month after the PCI procedure. The expected duration of participation for each
      patient is 14 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
time frame: 11 months
measure: Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
time frame: 11 months
measure: Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
time frame: 11 months
measure: All cause death
time frame: 14 months
measure: Death from cardiovascular causes
time frame: 14 months
measure: Myocardial infarction
time frame: 14 months
measure: Stroke
time frame: 14 months
measure: Bleeding events
time frame: 14 months
measure: Definite or probable stent thrombosis
time frame: 14 months
measure: Any target vessel revascularization
time frame: 14 months
measure: Urgent target vessel revascularization
time frame: 14 months
measure: Urgent non-target vessel revascularization
time frame: 14 months
measure: Clinically indicated non-target vessel revascularization
time frame: 14 months
measure: Transfusion rates both in patients with and/or without clinically detected over bleeding
time frame: 14 months
arm group label: Abbreviated antiplatelet regimen
arm group type: Other
description: Dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation).
In patients on oral anticoagulants, dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation)
arm group label: Prolonged antiplatelet regimen
arm group type: Other
description: Aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation).
In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation)
intervention type: Drug
intervention name: Aspirin
description: Dosing per current guidelines and local practice
arm group label: Abbreviated antiplatelet regimen
arm group label: Prolonged antiplatelet regimen
other name: antiplatelet agent
intervention type: Drug
intervention name: P2Y12 inhibitor
description: Dosing per current guidelines and local practice
arm group label: Abbreviated antiplatelet regimen
arm group label: Prolonged antiplatelet regimen
other name: antiplatelet agent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: M. Valgimigli, Prof.
role: Principal Investigator
affiliation: Cardiocentro Ticino Foundation, Lugano, Switzerland
last name: P. Smits, Dr.
role: Principal Investigator
affiliation: Maasstad Ziekenhuis Rotterdam, The Netherlands
last name: E. Spitzer, Dr.
role: Study Director
affiliation: ECRI bv
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country: Argentina
country: Australia
country: Austria
country: Bahrain
country: Bangladesh
country: Belgium
country: Bulgaria
country: Czechia
country: Denmark
country: Estonia
country: France
country: Germany
country: Hungary
country: India
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: North Macedonia
country: Poland
country: Saudi Arabia
country: Serbia
country: Singapore
country: Slovenia
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: Vietnam
country: Macedonia, The Former Yugoslav Republic of
citation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
PMID: 25173339
citation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
PMID: 26320110
citation: Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Hemorrhage
mesh term: Aspirin
mesh term: Platelet Aggregation Inhibitors
sharing ipd: Undecided