<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/NCT03252249</url>
  </required_header>
  <id_info>
    <org_study_id>AC16104</org_study_id>
    <nct_id>NCT03252249</nct_id>
  </id_info>
  <brief_title>Duration of Dual Anti-Platelet Therapy (DUAL-ACS)</brief_title>
  <official_title>Duration of Dual Anti-Platelet Therapy in Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</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>
      Despite substantial evidence supporting the use of dual anti-platelet therapy in patients&#xD;
      with acute coronary syndrome, there remains major uncertainty regarding the optimal duration&#xD;
      of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are&#xD;
      superior because the avoidance of atherothrombotic events is counterbalanced by the greater&#xD;
      risks of excess major bleeding with apparent increases in all-cause mortality with longer&#xD;
      durations. We here propose an international randomised controlled trial of 18,318 patients&#xD;
      with type 1 myocardial infarction allocated to differing durations of dual anti-platelet&#xD;
      therapy. We will use electronic health record linkage to track duration of therapy and&#xD;
      clinical outcomes in a real-world, real-time, efficient and highly cost-effective trial. This&#xD;
      has the potential to define treatment duration, settle a major outstanding international&#xD;
      controversy, and influence modern cardiology practice across the world.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2018</start_date>
  <completion_date type="Actual">February 4, 2023</completion_date>
  <primary_completion_date type="Actual">February 4, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-cardiovascular death (including fatal bleeding)</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major fatal and non-fatal bleeding</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisation for bleeding</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracranial haemorrhage</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal bleeding</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Transfusion</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin (testing and fall)</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron Therapy</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death and non-fatal myocardial infarction</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality (cardiac and non-cardiac)</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction (fatal and non-fatal)</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary revascularisation</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombotic stroke</measure>
    <time_frame>Randomisation to 15 months after the end of recruitment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4576</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>3 months dual anti-platelet therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 months dual anti-platelet therapy is the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12 months dual anti-platelet therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 months dual anti-platelet therapy is the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3 months dual anti-platelet therapy</intervention_name>
    <description>Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.</description>
    <arm_group_label>3 months dual anti-platelet therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>12 months dual anti-platelet therapy</intervention_name>
    <description>Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.</description>
    <arm_group_label>12 months dual anti-platelet therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥18 years&#xD;
&#xD;
          -  Clinical diagnosis of Type 1 myocardial infarction&#xD;
&#xD;
          -  In the opinion of the attending clinician requires dual anti-platelet therapy with&#xD;
             aspirin and a P2Y12 receptor antagonist&#xD;
&#xD;
          -  Resident in the country of recruitment with their unique health identifier&#xD;
&#xD;
          -  The attending clinician has equipoise regarding the duration of therapy&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clear indication for specific duration of dual anti-platelet therapy&#xD;
&#xD;
          -  Type 2 myocardial infarction&#xD;
&#xD;
          -  Contraindication to aspirin or P2Y12 receptor antagonist&#xD;
&#xD;
          -  Non-resident in the country of recruitment&#xD;
&#xD;
          -  Previous recruitment into the trial&#xD;
&#xD;
          -  Inability or unwilling to give informed consent&#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>David Newby</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edinburgh Royal Infirmary</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <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/NCT03252249
org study id: AC16104
nct id: NCT03252249
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite substantial evidence supporting the use of dual anti-platelet therapy in patients
      with acute coronary syndrome, there remains major uncertainty regarding the optimal duration
      of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are
      superior because the avoidance of atherothrombotic events is counterbalanced by the greater
      risks of excess major bleeding with apparent increases in all-cause mortality with longer
      durations. We here propose an international randomised controlled trial of 18,318 patients
      with type 1 myocardial infarction allocated to differing durations of dual anti-platelet
      therapy. We will use electronic health record linkage to track duration of therapy and
      clinical outcomes in a real-world, real-time, efficient and highly cost-effective trial. This
      has the potential to define treatment duration, settle a major outstanding international
      controversy, and influence modern cardiology practice across the world.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality
time frame: Randomisation to 15 months after the end of recruitment
measure: Non-cardiovascular death (Including fatal bleeding) and major non-fatal bleeding
time frame: Randomisation to 15 months after the end of recruitment
measure: Non-cardiovascular death (including fatal bleeding)
time frame: Randomisation to 15 months after the end of recruitment
measure: Major fatal and non-fatal bleeding
time frame: Randomisation to 15 months after the end of recruitment
measure: Hospitalisation for bleeding
time frame: Randomisation to 15 months after the end of recruitment
measure: Intracranial haemorrhage
time frame: Randomisation to 15 months after the end of recruitment
measure: Gastrointestinal bleeding
time frame: Randomisation to 15 months after the end of recruitment
measure: Blood Transfusion
time frame: Randomisation to 15 months after the end of recruitment
measure: Haemoglobin (testing and fall)
time frame: Randomisation to 15 months after the end of recruitment
measure: Iron Therapy
time frame: Randomisation to 15 months after the end of recruitment
measure: Cardiovascular death and non-fatal myocardial infarction
time frame: Randomisation to 15 months after the end of recruitment
measure: Cardiovascular mortality (cardiac and non-cardiac)
time frame: Randomisation to 15 months after the end of recruitment
measure: Myocardial infarction (fatal and non-fatal)
time frame: Randomisation to 15 months after the end of recruitment
measure: Stent Thrombosis
time frame: Randomisation to 15 months after the end of recruitment
measure: Coronary revascularisation
time frame: Randomisation to 15 months after the end of recruitment
measure: Thrombotic stroke
time frame: Randomisation to 15 months after the end of recruitment
arm group label: 3 months dual anti-platelet therapy
arm group type: Active Comparator
description: 3 months dual anti-platelet therapy is the intervention.
arm group label: 12 months dual anti-platelet therapy
arm group type: Active Comparator
description: 12 months dual anti-platelet therapy is the intervention.
intervention type: Other
intervention name: 3 months dual anti-platelet therapy
description: Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.
arm group label: 3 months dual anti-platelet therapy
intervention type: Other
intervention name: 12 months dual anti-platelet therapy
description: Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
arm group label: 12 months dual anti-platelet therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Newby
role: Principal Investigator
affiliation: University of Edinburgh
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No