xml: <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/NCT06014060</url>
    </required_header>
    <id_info>
      <org_study_id>Lipoprotein(a) and prognosis</org_study_id>
      <nct_id>NCT06014060</nct_id>
    </id_info>
    <brief_title>24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels</brief_title>
    <acronym>DAPT-Lp(a)</acronym>
    <official_title>24-Month Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</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 purpose of this study is (1) to determine whether 24-month dual antiplatelet therapy&#xD;
        (DAPT) is superior to 12-month DAPT after percutaneous coronary intervention (PCI) with&#xD;
        drug-eluting stent (DES) with respect to major adverse cardiovascular and cerebrovascular&#xD;
        events (all-cause death, myocardial infarction, or stroke) in patients with elevated&#xD;
        lipoprotein(a)[Lp(a)] levels (&gt;30mg/dL); (2) to determine whether 24-month DAPT is&#xD;
        non-inferior to 12-month DAPT after PCI with DES with respect to net adverse clinical events&#xD;
        (all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium&#xD;
        [BARC] type 3 or 5 bleeding) in patients with elevated Lp(a) levels (&gt;30mg/dL).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lp(a) levels play an important role in predicting subsequent ischemic events in patients with&#xD;
        established coronary artery disease (CAD), especially those who underwent PCI. However, there&#xD;
        are still no approved pharmacologic therapies that specifically target high Lp(a) levels.&#xD;
  &#xD;
        DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of&#xD;
        pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering&#xD;
        that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain&#xD;
        on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on&#xD;
        reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some&#xD;
        observational studies revealed that DAPT &gt; 1 year was significantly associated with lower&#xD;
        risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a)&#xD;
        levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and&#xD;
        safety of prolonged DAPT versus standard DAPT in this high-risk population has never been&#xD;
        assessed in randomized controlled trials (RCTs).&#xD;
  &#xD;
        The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with&#xD;
        blinded end-point evaluation. Consecutive patients with Lp(a) levels&gt;30mg/dL who meet the&#xD;
        inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to&#xD;
        24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients&#xD;
        with Lp(a) levels &gt;30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is&#xD;
        superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular&#xD;
        events (primary end point), while it is non-inferior to 12-month DAPT with respect to net&#xD;
        adverse clinical events (key secondary end point).&#xD;
  &#xD;
        The investigators estimated that 3,300 patients would be needed to provide the necessary&#xD;
        number of confirmed endpoints to test the study hypothesis. Patients will be followed up at&#xD;
        3, 6, 9, 12 months after randomization. All analyses will be performed according to the&#xD;
        intention-to-treat (ITT) principle.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>Single (Outcomes Assessor)</masking>
      <masking_description>Participants and study investigators were aware of the study-group assignments, but outcome adjudicators were not. All potential events were adjudicated according to prespecified criteria by an independent clinical events committee whose members were unaware of the trial-group assignments.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Major adverse cardiovascular and cerebrovascular event (MACCE)</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction or stroke.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Net adverse clinical event (NACE)</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)] type 3 or 5 bleeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular death or myocardial infarction</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause death or myocardial infarction</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause death</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with the occurrence of adjudicated all-cause death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular death</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with the occurrence of adjudicated cardiovascular death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any myocardial infarction</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated any myocardial infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target vessel myocardial infarction</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated target vessel myocardial infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemic stroke</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated ischemic stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemorrhagic stroke</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated hemorrhagic stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Definite/probable stent thrombosis</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated definite/probable stent thrombosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Repeat revascularization</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated repeat revascularization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target vessel revascularization</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated target vessel revascularization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any bleeding</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated any bleeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BARC type 2, 3 or 5 bleeding</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated BARC type 2, 3 or 5 bleeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BARC type 3 or 5 bleeding</measure>
      <time_frame>12 months after randomization</time_frame>
      <description>Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">3300</enrollment>
    <condition>Elevated Lipoprotein(a) Level</condition>
    <condition>Coronary Artery Disease</condition>
    <condition>Drug-Eluting Stent</condition>
    <condition>Dual Antiplatelet Therapy</condition>
    <arm_group>
      <arm_group_label>24 Months DAPT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>12 Months DAPT</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Dual antiplatelet therapy will be discontinued and patients will receive aspirin monotherapy for 12 months after randomisation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>24 Months DAPT</intervention_name>
      <description>All subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization.</description>
      <arm_group_label>24 Months DAPT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>12 Months DAPT</intervention_name>
      <description>All subjects will receive aspirin (100 mg/day) monotherapy without co-administration of clopidogrel for 12 months after randomization.</description>
      <arm_group_label>12 Months DAPT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or nonpregnant female between 18-75 years;&#xD;
  &#xD;
            2. Subjects with Lp(a) levels &gt; 30mg/dL before percutaneous coronary intervention (PCI);&#xD;
  &#xD;
            3. Subjects who are event-free at 1 year after PCI with drug-eluting stent (DES);&#xD;
  &#xD;
            4. Subjects (or legal guardian) understand the trial requirements and the treatment&#xD;
               procedures and provides written informed;&#xD;
  &#xD;
            5. Subjects are willing to comply with all protocol-required follow-up evaluation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with Lp(a) &lt; 30mg/dL or Lp(a) level unavailable before PCI;&#xD;
  &#xD;
            2. Subjects who experience adverse cardiovascular events (death, myocardial infarction,&#xD;
               stent thrombosis, stroke, repeat coronary revascularization, or Bleeding Academic&#xD;
               Research Consortium [BARC] type 2, 3 or 5 bleeding) within 1-year after PCI;&#xD;
  &#xD;
            3. Subjects who have other diseases requiring dual antiplatelet therapy (DAPT) such as&#xD;
               peripheral vascular disease;&#xD;
  &#xD;
            4. Subjects who cannot tolerate DAPT therapy or receive anticoagulation therapy at the&#xD;
               time of randomization;&#xD;
  &#xD;
            5. Planned surgery necessitating discontinuation of antiplatelet therapy (&gt;14 days)&#xD;
               within the 12 months after randomization;&#xD;
  &#xD;
            6. Systolic blood pressure &lt; 90mmHg for &gt; 30 minutes accompanied by hypoperfusion&#xD;
               symptoms or systolic blood pressure ≥ 90mmHg is maintained with&#xD;
               mechanical/pharmacologic hemodynamic support;&#xD;
  &#xD;
            7. Unstable or severe pulmonary edema/decompensated congestive heart failure;&#xD;
  &#xD;
            8. Moderate to severe heart failure (New York Heart Association [NYHA] Functional&#xD;
               Classification III or IV) or last known left ventricular ejection fraction (LVEF) &lt;&#xD;
               40%;&#xD;
  &#xD;
            9. Severe valvular heart disease, myocarditis or cardiomyopathy;&#xD;
  &#xD;
           10. Recurrent symptoms of ischemia;&#xD;
  &#xD;
           11. Severe renal dysfunction, defined as creatinine clearance &lt;30 mL/min or estimated&#xD;
               glomerular filtration (eGFR) rate less than 30 ml/min/1.73m2, or requirement for&#xD;
               peritoneal dialysis or hemodialysis for renal insufficiency;&#xD;
  &#xD;
           12. History or clinical evidence of active liver disease or hepatic dysfunction, defined&#xD;
               as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 3 × upper&#xD;
               limit of normal (ULN), or total bilirubin &gt; 2 × ULN; Unexplained elevated creatine&#xD;
               kinase (CK) concentration &gt;5 × ULN or elevation due to known muscle disease;&#xD;
  &#xD;
           13. Severe acute or chronic infectious disease;&#xD;
  &#xD;
           14. History of severe rheumatic immune disease or malignant tumor;&#xD;
  &#xD;
           15. Currently receiving treatment in another investigational device or drug study, or less&#xD;
               than 30 days since ending treatment on another investigational device or drug&#xD;
               study(ies), or receiving other investigational agent(s);&#xD;
  &#xD;
           16. Drug or alcohol abuse, and inability/unwillingness to abstain from drug abuse and&#xD;
               excessive alcohol consumption during the study;&#xD;
  &#xD;
           17. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal);&#xD;
  &#xD;
           18. Subject likely to not be available to complete all protocol-required study visits or&#xD;
               procedures, and/or to comply with all required study procedures (eg, Clinical Outcome&#xD;
               Assessments) to the best of the subject and investigator's knowledge;&#xD;
  &#xD;
           19. Any uncontrolled or serious disease, or any medical or surgical condition (such as&#xD;
               known active infection or major hematologic, renal, metabolic, gastrointestinal or&#xD;
               endocrine dysfunction, or a chronic disease or infection [eg, HIV]), that may either&#xD;
               interfere with participation in the clinical study and is not currently stable and&#xD;
               appropriately managed in the judgment of the investigator, and/or put the subject at&#xD;
               significant risk (according to investigator's judgment) if he/she participates in the&#xD;
               clinical study;&#xD;
  &#xD;
           20. Mental/psychological impairment/neurocognitive disorder, or any other reason to expect&#xD;
               patient difficulty in complying with the requirements of the study or understanding&#xD;
               the goal and potential risks of participating in the study;&#xD;
  &#xD;
           21. Concurrent medical condition with a life expectancy of &lt; 1 year;&#xD;
  &#xD;
           22. Subject unable to give informed consent;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kefei Dou, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kongyong Cui, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kefei Dou, MD, PhD</last_name>
      <phone>+86-10-13801032912</phone>
      <email>drdoukefei@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kongyong Cui,, PhD</last_name>
      <phone>+86-10-15210519790</phone>
      <email>cardio_kongyong@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Kefei Dou, MD, PhD</last_name>
        <phone>+86-10-13801032912</phone>
        <email>drdoukefei@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Kongyong Cui, MD, PhD</last_name>
        <phone>+86-10-15210519790</phone>
        <email>cardio_kongyong@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
      <investigator_full_name>Kefei Dou, MD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Lipoprotein(a)</keyword>
    <keyword>Coronary Artery Disease</keyword>
    <keyword>Drug-Eluting Stent</keyword>
    <keyword>Percutaneous Coronary Intervention</keyword>
    <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>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014060
  org study id: Lipoprotein(a) and prognosis
  nct id: NCT06014060
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is (1) to determine whether 24-month dual antiplatelet therapy
        (DAPT) is superior to 12-month DAPT after percutaneous coronary intervention (PCI) with
        drug-eluting stent (DES) with respect to major adverse cardiovascular and cerebrovascular
        events (all-cause death, myocardial infarction, or stroke) in patients with elevated
        lipoprotein(a)[Lp(a)] levels (>30mg/dL); (2) to determine whether 24-month DAPT is
        non-inferior to 12-month DAPT after PCI with DES with respect to net adverse clinical events
        (all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium
        [BARC] type 3 or 5 bleeding) in patients with elevated Lp(a) levels (>30mg/dL).
  Lp(a) levels play an important role in predicting subsequent ischemic events in patients with
        established coronary artery disease (CAD), especially those who underwent PCI. However, there
        are still no approved pharmacologic therapies that specifically target high Lp(a) levels.
  
        DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of
        pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering
        that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain
        on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on
        reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some
        observational studies revealed that DAPT > 1 year was significantly associated with lower
        risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a)
        levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and
        safety of prolonged DAPT versus standard DAPT in this high-risk population has never been
        assessed in randomized controlled trials (RCTs).
  
        The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with
        blinded end-point evaluation. Consecutive patients with Lp(a) levels>30mg/dL who meet the
        inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to
        24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients
        with Lp(a) levels >30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is
        superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular
        events (primary end point), while it is non-inferior to 12-month DAPT with respect to net
        adverse clinical events (key secondary end point).
  
        The investigators estimated that 3,300 patients would be needed to provide the necessary
        number of confirmed endpoints to test the study hypothesis. Patients will be followed up at
        3, 6, 9, 12 months after randomization. All analyses will be performed according to the
        intention-to-treat (ITT) principle.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Participants and study investigators were aware of the study-group assignments, but outcome adjudicators were not. All potential events were adjudicated according to prespecified criteria by an independent clinical events committee whose members were unaware of the trial-group assignments.
  measure: Major adverse cardiovascular and cerebrovascular event (MACCE)
  time frame: 12 months after randomization
  description: The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction or stroke.
  measure: Net adverse clinical event (NACE)
  time frame: 12 months after randomization
  description: The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)] type 3 or 5 bleeding.
  measure: Cardiovascular death or myocardial infarction
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction.
  measure: All-cause death or myocardial infarction
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction.
  measure: All-cause death
  time frame: 12 months after randomization
  description: Number of patients with the occurrence of adjudicated all-cause death.
  measure: Cardiovascular death
  time frame: 12 months after randomization
  description: Number of patients with the occurrence of adjudicated cardiovascular death.
  measure: Any myocardial infarction
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated any myocardial infarction.
  measure: Target vessel myocardial infarction
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated target vessel myocardial infarction.
  measure: Stroke
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated stroke.
  measure: Ischemic stroke
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated ischemic stroke.
  measure: Hemorrhagic stroke
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated hemorrhagic stroke.
  measure: Definite/probable stent thrombosis
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated definite/probable stent thrombosis.
  measure: Repeat revascularization
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated repeat revascularization.
  measure: Target vessel revascularization
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated target vessel revascularization.
  measure: Any bleeding
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated any bleeding.
  measure: BARC type 2, 3 or 5 bleeding
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated BARC type 2, 3 or 5 bleeding.
  measure: BARC type 3 or 5 bleeding
  time frame: 12 months after randomization
  description: Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding.
  arm group label: 24 Months DAPT
  arm group type: Experimental
  description: Dual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation.
  arm group label: 12 Months DAPT
  arm group type: Active Comparator
  description: Dual antiplatelet therapy will be discontinued and patients will receive aspirin monotherapy for 12 months after randomisation.
  intervention type: Procedure
  intervention name: 24 Months DAPT
  description: All subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization.
  arm group label: 24 Months DAPT
  intervention type: Procedure
  intervention name: 12 Months DAPT
  description: All subjects will receive aspirin (100 mg/day) monotherapy without co-administration of clopidogrel for 12 months after randomization.
  arm group label: 12 Months DAPT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Kefei Dou, MD, PhD
  role: Principal Investigator
  affiliation: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  last name: Kongyong Cui, MD, PhD
  role: Principal Investigator
  affiliation: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  last name: Kefei Dou, MD, PhD
  phone: +86-10-13801032912
  email: drdoukefei@126.com
  last name: Kongyong Cui,, PhD
  phone: +86-10-15210519790
  email: cardio_kongyong@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: China National Center for Cardiovascular Diseases
  investigator full name: Kefei Dou, MD
  investigator title: Professor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: No