<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/NCT01701453</url>
  </required_header>
  <id_info>
    <org_study_id>2011-12-070</org_study_id>
    <nct_id>NCT01701453</nct_id>
  </id_info>
  <brief_title>Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)</brief_title>
  <acronym>SMART-DATE</acronym>
  <official_title>Smart Angioplasty Research Team: Safety of 6-month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes (SMART-DATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT)&#xD;
           compared to conventional 12-month-or-longer duration after second-generation&#xD;
           drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).&#xD;
&#xD;
        2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or&#xD;
           longer duration of DAPT at preventing the occurrence of major adverse cardiac and&#xD;
           cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in&#xD;
           patients with ACS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Primary endpoint&#xD;
&#xD;
           - MACCE, defined as a composite of all-cause mortality, myocardial infarction, and&#xD;
           cerebrovascular events at 18 months after the index procedure.&#xD;
&#xD;
        2. Secondary endpoint&#xD;
&#xD;
             -  Individual components of the primary endpoint at 18-month after the index procedure&#xD;
&#xD;
             -  Definite/probable stent thrombosis, defined by the Academic Research Consortium&#xD;
                (ARC) at 18-month after the index procedure.&#xD;
&#xD;
             -  Bleeding complication, defined by Bleeding Academic Research Consortium (BARC) type&#xD;
                2 to 5 at 18-month after the index procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Actual">November 2017</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>A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event</measure>
    <time_frame>at 18-month after the index procedure</time_frame>
    <description>defined as MACCE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>at 18-month after the index procedure</time_frame>
    <description>Individual component of MACCE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous MI</measure>
    <time_frame>at 18-month after the index procedure</time_frame>
    <description>Individual component of MACCE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular event</measure>
    <time_frame>at 18-month after the index procedure</time_frame>
    <description>Individual component of MACCE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>at 18-month after the index procedure</time_frame>
    <description>Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>at 18-month after the index procedure</time_frame>
    <description>Bleeding Academic Research Consortium (BARC) type 2 to 5</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2712</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>6 months group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12 months or longer group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)</intervention_name>
    <description>P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)</description>
    <arm_group_label>12 months or longer group</arm_group_label>
    <arm_group_label>6 months group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be ≥ 20 years.&#xD;
&#xD;
          2. Subject is able to verbally confirm understandings of risks, benefits and treatment&#xD;
             alternatives of receiving percutaneous coronary intervention and he/she or his/her&#xD;
             legally authorized representative provides written informed consent prior to any study&#xD;
             related procedure.&#xD;
&#xD;
          3. Subject must have a culprit lesion in a native coronary artery with significant&#xD;
             stenosis (&gt;50% by visual estimate) eligible for stent implantation.&#xD;
&#xD;
          4. Subject must have clinical diagnosis of ACS that includes unstable angina and MI. The&#xD;
             specific definitions of ACS, as follows; 1) ST-segment elevation MI (STEMI) :&#xD;
             elevation of ST-segment more than 0.1 mV in 2 or more contiguous electrocardiographic&#xD;
             (ECG) leads or new left bundle-branch block with elevated biomarkers of myocardial&#xD;
             necrosis 2) Non-ST-segment elevation MI (NSTEMI) : Elevated biomarkers of myocardial&#xD;
             necrosis (troponin or CK-MB &gt; upper reference limit) with one of the following; (a)&#xD;
             Transient ST-segment elevation or depression, or T-wave changes consistent with&#xD;
             myocardial ischemia, (b) Identification of a culprit lesion at coronary angiography 3)&#xD;
             Unstable angina : An accelerating pattern or recurrent episodes of chest pain at rest&#xD;
             or with minimal effort and new ST-segment depression of at least 0.05 mV, or T wave&#xD;
             inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina&#xD;
             were based on the TACTICS-TIMI 18 trial.&#xD;
&#xD;
          5. Target lesion(s) must be located in a native coronary artery with visually estimated&#xD;
             diameter of ≥ 2.25 mm and ≤ 4.25 mm.&#xD;
&#xD;
          6. Target lesion(s) must be amenable for percutaneous coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient has a known hypersensitivity or contraindication to any of the following&#xD;
             medications: Heparin, Aspirin, Clopidogrel, Biolimus, Everolimus, Zotarolimus, and&#xD;
             Contrast media (Patients with documented sensitivity to contrast media which can be&#xD;
             effectively premedicated with steroids and diphenhydramine [e.g. rash] may be&#xD;
             enrolled. Those with true anaphylaxis to prior contrast media, however, should not be&#xD;
             enrolled.)&#xD;
&#xD;
          2. Patients with active pathologic bleeding&#xD;
&#xD;
          3. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery&#xD;
             within 2 months.&#xD;
&#xD;
          4. Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months.&#xD;
&#xD;
          5. Female of childbearing potential, unless a recent pregnancy test is negative, who&#xD;
             possibly plan to become pregnant any time after enrollment into this study.&#xD;
&#xD;
          6. History of bleeding diathesis, known coagulopathy (including heparin-induced&#xD;
             thrombocytopenia), or will refuse blood transfusions&#xD;
&#xD;
          7. Noncardiac comorbid conditions are present with life expectancy &lt;1 year or that may&#xD;
             result in protocol noncompliance (per site investigator's medical judgment).&#xD;
&#xD;
          8. An elective surgical procedure is planned that would necessitate interruption of&#xD;
             clopidogrel during the first 12 months post enrollment.&#xD;
&#xD;
          9. Patients who are actively participating in another drug or device investigational&#xD;
             study, which have not completed the primary endpoint follow-up period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyeon-Cheol Gwon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Hyeon-Cheol Gwon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>duration of DAPT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Ticagrelor</mesh_term>
    <mesh_term>Prasugrel Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After publication of first manuscript</ipd_description>
  </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/NCT01701453
org study id: 2011-12-070
nct id: NCT01701453
lead sponsor: 
has dmc: Yes
1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT)
           compared to conventional 12-month-or-longer duration after second-generation
           drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).

        2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or
           longer duration of DAPT at preventing the occurrence of major adverse cardiac and
           cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in
           patients with ACS.
1. Primary endpoint

           - MACCE, defined as a composite of all-cause mortality, myocardial infarction, and
           cerebrovascular events at 18 months after the index procedure.

        2. Secondary endpoint

             -  Individual components of the primary endpoint at 18-month after the index procedure

             -  Definite/probable stent thrombosis, defined by the Academic Research Consortium
                (ARC) at 18-month after the index procedure.

             -  Bleeding complication, defined by Bleeding Academic Research Consortium (BARC) type
                2 to 5 at 18-month after the index procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event
time frame: at 18-month after the index procedure
description: defined as MACCE
measure: All-cause mortality
time frame: at 18-month after the index procedure
description: Individual component of MACCE
measure: Spontaneous MI
time frame: at 18-month after the index procedure
description: Individual component of MACCE
measure: Cerebrovascular event
time frame: at 18-month after the index procedure
description: Individual component of MACCE
measure: Stent thrombosis
time frame: at 18-month after the index procedure
description: Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)
measure: Bleeding
time frame: at 18-month after the index procedure
description: Bleeding Academic Research Consortium (BARC) type 2 to 5
arm group label: 6 months group
arm group type: Experimental
description: 6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
arm group label: 12 months or longer group
arm group type: Experimental
description: 12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
intervention type: Drug
intervention name: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
description: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
arm group label: 12 months or longer group
arm group label: 6 months group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hyeon-Cheol Gwon, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Hyeon-Cheol Gwon
investigator title: Professor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Clopidogrel
mesh term: Ticagrelor
mesh term: Prasugrel Hydrochloride
sharing ipd: Yes
ipd description: After publication of first manuscript