<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/NCT04418479</url>
  </required_header>
  <id_info>
    <org_study_id>CHOICE-3</org_study_id>
    <nct_id>NCT04418479</nct_id>
  </id_info>
  <brief_title>SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3</brief_title>
  <acronym>SMART-CHOICE3</acronym>
  <official_title>Clopidogrel Versus Aspirin Monotherapy Beyond Twelve Months After Percutaneous Coronary Intervention in Patients at High Risk for Recurrent Ischemic Events</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joo-Yong Hahn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      This study is prospective, open-label, two-arm, randomized multicenter trial to evaluate the&#xD;
      efficacy and safety of clopidogrel monotherapy as compared with aspirin monotherapy beyond 12&#xD;
      months after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in&#xD;
      patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent&#xD;
      ischemic events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the introduction of the second-generation drug-eluting stents (DES), the rates of&#xD;
      device-related failure or target lesion failure such as restenosis and stent thrombosis has&#xD;
      been markedly decreased, compared with the era of bare-metal stents or first-generation DES.&#xD;
      Nevertheless, the risk of ischemic events including very late stent thrombosis after&#xD;
      percutaneous coronary intervention (PCI) has still remained even though the use of&#xD;
      second-generation DES. In this regard, the ACC (American College of Cardiology)/AHA (American&#xD;
      Heart Association) and ESC (European Society of Cardiology) guidelines recommended that dual&#xD;
      antiplatelet therapy (DAPT) should be considered for 12 months or longer in patients&#xD;
      presented with acute coronary syndrome (ACS) and for 6 months or longer in patients presented&#xD;
      with stable ischemic heart disease (SIHD) after PCI with DES. In particular, patients&#xD;
      presented with a high risk of ischemic events such as diabetes mellitus, myocardial&#xD;
      infarction, or complex coronary lesions were associated with significantly increased future&#xD;
      recurrent ischemic events after PCI with DES. In addition, maintenance of DAPT for 12 months&#xD;
      or longer has been shown to reduce the recurrence of ischemic events up to 44% in patients&#xD;
      treated with PCI for complex coronary artery lesion; therefore the current guideline&#xD;
      recommended that prolonged DAPT might be considered when performing complex PCI. However,&#xD;
      prolonged DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures&#xD;
      are often delayed due to prolonged DAPT, which may affect the patient's quality of life.&#xD;
      Therefore, to determine the optimal or minimal necessary duration of DAPT is very important.&#xD;
&#xD;
      The other important issue is that which antiplatelet agent is more appropriate after DAPT.&#xD;
      Aspirin monotherapy has been recommended traditionally. However, there is no randomized&#xD;
      comparison study between aspirin monotherapy versus clopidogrel monotherapy after DAPT in&#xD;
      patients undergoing PCI with DES. Furthermore, clopidogrel is also actively used as a&#xD;
      monotherapy after DAPT in real-world practice. In CAPRIE (clopidogrel versus aspirin in&#xD;
      patients at risk of ischemic events) trial, clopidogrel showed a superior efficacy in&#xD;
      preventing ischemic events compared with aspirin. Moreover, the incidence of gastrointestinal&#xD;
      bleeding was significantly lower with clopidogrel than with aspirin. Clopidogrel monotherapy&#xD;
      can reduce ischemic events and bleeding risk compared with aspirin monotherapy.&#xD;
&#xD;
      Therefore, the purpose of the SMART-CHOICE 3 (SMart Angioplasty Research Team: CHoice of&#xD;
      Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting&#xD;
      Stents 3) trial is to determine the efficacy and safety of clopidogrel monotherapy as&#xD;
      compared with aspirin monotherapy beyond 12 months after PCI with current-generation DES in&#xD;
      patients being treated with DAPT at high risk for recurrent ischemic events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>
    <intervention_model_description>Prospective, open-label, two-arm, randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of major adverse cardiac and cerebrovascular event (MACCE)</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>a composite of all-cause death, myocardial infarction, or stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of all-cause death</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cardiac death</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Death by cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of myocardial infarction</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of stroke</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of stent thrombosis</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>definite or probable by Academic Research Consortium [ARC] definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of all-cause death or MI</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>A composite of all-cause death or MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cardiac death or MI</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>A composite of cardiac death or MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cardiac death, MI, or stroke</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>A composite of cardiac death, MI, or stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cardiac death, MI, or stent thrombosis</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>A composite of cardiac death, MI, or stent thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of major Bleeding</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>BARC [Bleeding Academic Research Consortium] types 3 or 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of bleeding</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>BARC [Bleeding Academic Research Consortium] types 2, 3, or 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of upper gastrointestinal clinical event</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>A composite of upper gastrointestinal clinical event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of gastrointestinal ulcer or bleeding</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>A composite of gastrointestinal ulcer or bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New diagnosed rates of gastroesophageal reflux disease (GERD)</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Gastroesophageal reflux disease (GERD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of NACE (Net adverse clinical events)</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>MACCE + BARC type 3 or 5 bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Target-lesion revascularization (TLR)</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Target-lesion revascularization (TLR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Target-vessel revascularization (TVR)</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Target-vessel revascularization (TVR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of any revascularization</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical cost</measure>
    <time_frame>1-year after last patient enrollment</time_frame>
    <description>Medical cost</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Aspirin monotherapy arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 100 mg of aspirin once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clopidogrel monotherapy arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 75 mg of clopidogrel once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).&#xD;
This group will be taken aspirin 100 mg once daily during the study period.</description>
    <arm_group_label>Aspirin monotherapy arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).&#xD;
This group will be taken clopidogrel 75 mg once daily during the study period.</description>
    <arm_group_label>Clopidogrel monotherapy arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i) Subject must be at least 19 years of age&#xD;
&#xD;
        ii) Subject who is able to understand risks, benefits and treatment alternatives and sign&#xD;
        informed consent voluntarily.&#xD;
&#xD;
        iii) Patients being treated with DAPT at high risk for recurrent ischemic events* who&#xD;
        underwent PCI at least 12 months ago.&#xD;
&#xD;
        *High risk for recurrent ischemic events was defined as one or more of the following&#xD;
        clinical or lesion characteristics.&#xD;
&#xD;
        A. Clinical characteristics&#xD;
&#xD;
          1. Patients presented with acute myocardial infarction.&#xD;
&#xD;
          2. Patients with diabetes mellitus who receiving oral hypoglycemic agent or insulin.&#xD;
&#xD;
        B. Complex lesion characteristics**&#xD;
&#xD;
        **Complex lesion was defined as one or more of the following.&#xD;
&#xD;
          1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side&#xD;
             branch ostium&#xD;
&#xD;
          2. Chronic total occlusion (≥3 months) as target lesion&#xD;
&#xD;
          3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation&#xD;
             including non-true bifurcation lesions)&#xD;
&#xD;
          4. Long coronary lesions (implanted stent length ≥38 mm)&#xD;
&#xD;
          5. Multi-vessel PCI (≥ 2 vessels treated at one PCI session)&#xD;
&#xD;
          6. Multiple stent needed (≥ 3 stents per patient)&#xD;
&#xD;
          7. In-stent restenosis lesion as target lesion&#xD;
&#xD;
          8. Severely calcified lesion (encircling calcium in angiography)&#xD;
&#xD;
          9. Ostial lesions of left anterior descending artery, left circumflex artery, or right&#xD;
             coronary artery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i) Known hypersensitivity or contraindications to study medications (aspirin or&#xD;
        clopidogrel)&#xD;
&#xD;
        ii) Patients taking warfarin or non-vitamin K antagonist (dabigatran, rivaroxaban,&#xD;
        edoxaban, or apixaban)&#xD;
&#xD;
        iii) Patients who require DAPT due to atherosclerotic disease other than coronary artery&#xD;
        disease&#xD;
&#xD;
        iv) Patients who are scheduled for revascularization treatment of coronary artery&#xD;
&#xD;
        v) Pregnant or lactating women&#xD;
&#xD;
        vi) Non-cardiac co-morbid conditions are present with life expectancy &lt;2 year or that may&#xD;
        result in protocol non-compliance (per site investigator's medical judgment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joo-Yong Hahn, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joo-Yong Hahn, MD, PhD</last_name>
    <phone>82-2-3410-1246</phone>
    <email>jyhahn@skku.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ki Hong Choi, MD</last_name>
    <phone>82-2-3410-6653</phone>
    <email>cardiokh@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joo-Yong Hahn, MD, PhD</last_name>
      <phone>82-2-3410-6653</phone>
      <email>ichjy1@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Joo-Yong Hahn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <keyword>Antiplatelet Therapy</keyword>
  <keyword>Complex Coronary Lesion</keyword>
  <keyword>Aspirin</keyword>
  <keyword>Clopidogrel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Clopidogrel</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/NCT04418479
org study id: CHOICE-3
nct id: NCT04418479
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is prospective, open-label, two-arm, randomized multicenter trial to evaluate the
      efficacy and safety of clopidogrel monotherapy as compared with aspirin monotherapy beyond 12
      months after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in
      patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent
      ischemic events.
After the introduction of the second-generation drug-eluting stents (DES), the rates of
      device-related failure or target lesion failure such as restenosis and stent thrombosis has
      been markedly decreased, compared with the era of bare-metal stents or first-generation DES.
      Nevertheless, the risk of ischemic events including very late stent thrombosis after
      percutaneous coronary intervention (PCI) has still remained even though the use of
      second-generation DES. In this regard, the ACC (American College of Cardiology)/AHA (American
      Heart Association) and ESC (European Society of Cardiology) guidelines recommended that dual
      antiplatelet therapy (DAPT) should be considered for 12 months or longer in patients
      presented with acute coronary syndrome (ACS) and for 6 months or longer in patients presented
      with stable ischemic heart disease (SIHD) after PCI with DES. In particular, patients
      presented with a high risk of ischemic events such as diabetes mellitus, myocardial
      infarction, or complex coronary lesions were associated with significantly increased future
      recurrent ischemic events after PCI with DES. In addition, maintenance of DAPT for 12 months
      or longer has been shown to reduce the recurrence of ischemic events up to 44% in patients
      treated with PCI for complex coronary artery lesion; therefore the current guideline
      recommended that prolonged DAPT might be considered when performing complex PCI. However,
      prolonged DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures
      are often delayed due to prolonged DAPT, which may affect the patient's quality of life.
      Therefore, to determine the optimal or minimal necessary duration of DAPT is very important.

      The other important issue is that which antiplatelet agent is more appropriate after DAPT.
      Aspirin monotherapy has been recommended traditionally. However, there is no randomized
      comparison study between aspirin monotherapy versus clopidogrel monotherapy after DAPT in
      patients undergoing PCI with DES. Furthermore, clopidogrel is also actively used as a
      monotherapy after DAPT in real-world practice. In CAPRIE (clopidogrel versus aspirin in
      patients at risk of ischemic events) trial, clopidogrel showed a superior efficacy in
      preventing ischemic events compared with aspirin. Moreover, the incidence of gastrointestinal
      bleeding was significantly lower with clopidogrel than with aspirin. Clopidogrel monotherapy
      can reduce ischemic events and bleeding risk compared with aspirin monotherapy.

      Therefore, the purpose of the SMART-CHOICE 3 (SMart Angioplasty Research Team: CHoice of
      Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting
      Stents 3) trial is to determine the efficacy and safety of clopidogrel monotherapy as
      compared with aspirin monotherapy beyond 12 months after PCI with current-generation DES in
      patients being treated with DAPT at high risk for recurrent ischemic events.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, open-label, two-arm, randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Rates of major adverse cardiac and cerebrovascular event (MACCE)
time frame: 1-year after last patient enrollment
description: a composite of all-cause death, myocardial infarction, or stroke
measure: Rates of all-cause death
time frame: 1-year after last patient enrollment
description: Death by any cause
measure: Rates of cardiac death
time frame: 1-year after last patient enrollment
description: Death by cardiac cause
measure: Rates of myocardial infarction
time frame: 1-year after last patient enrollment
description: Myocardial infarction
measure: Rates of stroke
time frame: 1-year after last patient enrollment
description: Stroke
measure: Rates of stent thrombosis
time frame: 1-year after last patient enrollment
description: definite or probable by Academic Research Consortium [ARC] definition
measure: Rates of all-cause death or MI
time frame: 1-year after last patient enrollment
description: A composite of all-cause death or MI
measure: Rates of cardiac death or MI
time frame: 1-year after last patient enrollment
description: A composite of cardiac death or MI
measure: Rates of cardiac death, MI, or stroke
time frame: 1-year after last patient enrollment
description: A composite of cardiac death, MI, or stroke
measure: Rates of cardiac death, MI, or stent thrombosis
time frame: 1-year after last patient enrollment
description: A composite of cardiac death, MI, or stent thrombosis
measure: Rates of major Bleeding
time frame: 1-year after last patient enrollment
description: BARC [Bleeding Academic Research Consortium] types 3 or 5
measure: Rates of bleeding
time frame: 1-year after last patient enrollment
description: BARC [Bleeding Academic Research Consortium] types 2, 3, or 5
measure: Rates of upper gastrointestinal clinical event
time frame: 1-year after last patient enrollment
description: A composite of upper gastrointestinal clinical event
measure: Rates of gastrointestinal ulcer or bleeding
time frame: 1-year after last patient enrollment
description: A composite of gastrointestinal ulcer or bleeding
measure: New diagnosed rates of gastroesophageal reflux disease (GERD)
time frame: 1-year after last patient enrollment
description: Gastroesophageal reflux disease (GERD)
measure: Rates of NACE (Net adverse clinical events)
time frame: 1-year after last patient enrollment
description: MACCE + BARC type 3 or 5 bleeding
measure: Rates of Target-lesion revascularization (TLR)
time frame: 1-year after last patient enrollment
description: Target-lesion revascularization (TLR)
measure: Rates of Target-vessel revascularization (TVR)
time frame: 1-year after last patient enrollment
description: Target-vessel revascularization (TVR)
measure: Rates of any revascularization
time frame: 1-year after last patient enrollment
description: any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention
measure: Medical cost
time frame: 1-year after last patient enrollment
description: Medical cost
arm group label: Aspirin monotherapy arm
arm group type: Active Comparator
description: Patients will receive 100 mg of aspirin once daily.
arm group label: Clopidogrel monotherapy arm
arm group type: Experimental
description: Patients will receive 75 mg of clopidogrel once daily.
intervention type: Drug
intervention name: Aspirin
description: Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
This group will be taken aspirin 100 mg once daily during the study period.
arm group label: Aspirin monotherapy arm
intervention type: Drug
intervention name: Clopidogrel
description: Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
This group will be taken clopidogrel 75 mg once daily during the study period.
arm group label: Clopidogrel monotherapy arm
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Joo-Yong Hahn, MD, PhD
role: Study Chair
affiliation: Samsung Medical Center
last name: Joo-Yong Hahn, MD, PhD
phone: 82-2-3410-1246
email: jyhahn@skku.edu
last name: Ki Hong Choi, MD
phone: 82-2-3410-6653
email: cardiokh@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Joo-Yong Hahn
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Aspirin
mesh term: Clopidogrel