<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/NCT04501900</url>
  </required_header>
  <id_info>
    <org_study_id>ZS20200804</org_study_id>
    <nct_id>NCT04501900</nct_id>
  </id_info>
  <brief_title>The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation</brief_title>
  <acronym>SPARTA</acronym>
  <official_title>The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after&#xD;
      XINSORB BRS implantation by investigating the balance of risk and benefit in a broad&#xD;
      population of treated patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">April 2026</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>3 years</time_frame>
    <description>The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BARC type 3, 4, and 5 bleeding events</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2106</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>prolonged DAPT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>standard DAPT group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel</intervention_name>
    <description>Study subjects diagnosed as stable, unstable ischemic coronary disease or myocardial infarction planning to undergo percutaneous coronary intervention (PCI) and no contradiction to prolonged DAPT are eligible for this trial. All subjects will provide written informed consent to participate. Subjects will be enrolled into the study before or within 24 hours after the index procedure. Subjects will be randomized to either discontinue P2Y12 inhibitor (clopidogrel or ticagrelor) (12 months total) or receive P2Y12 inhibitor for an additional 24 months (36 months total). Aspirin will be maintained in the entire study and can be replaced by cilostazol or indobufen if subjects are intolerant. Dosage of antiplatelet drugs will be according to local standard of practice. Subjects will be treated with XINSORB BRS only.</description>
    <arm_group_label>prolonged DAPT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months&#xD;
&#xD;
          2. Written informed consent from the subjects&#xD;
&#xD;
          3. Qualified candidates for coronary bypass surgery&#xD;
&#xD;
          4. Lesions with reference vessel diameter 2.75 to 3.5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age ≤ 18 years&#xD;
&#xD;
          2. Cardiogenetic shock&#xD;
&#xD;
          3. Chronic heart failure with a left ventricular ejection fraction ≤ 30%&#xD;
&#xD;
          4. Oral anticoagulation therapy&#xD;
&#xD;
          5. Known allergy or intolerance to the study medications&#xD;
&#xD;
          6. Malignancies and other comorbid conditions with a life expectancy less than 5 years&#xD;
&#xD;
          7. Subjects treated with both BRS and DES during the index procedure&#xD;
&#xD;
          8. Pregnant wowen&#xD;
&#xD;
          9. Planned staged PCI&#xD;
&#xD;
         10. Contemporaneous enrollment in a different clinical trial&#xD;
&#xD;
         11. Any revascularization within 1 year&#xD;
&#xD;
         12. Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months&#xD;
             after enrollment&#xD;
&#xD;
         13. Unprotected left main artery&#xD;
&#xD;
         14. Lesions located at the ostium of the main coronary artery&#xD;
&#xD;
         15. bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</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>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04501900
org study id: ZS20200804
nct id: NCT04501900
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after
      XINSORB BRS implantation by investigating the balance of risk and benefit in a broad
      population of treated patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MACE
time frame: 3 years
description: The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization
measure: BARC type 3, 4, and 5 bleeding events
time frame: 3 years
arm group label: prolonged DAPT group
arm group type: Active Comparator
arm group label: standard DAPT group
arm group type: No Intervention
intervention type: Drug
intervention name: Clopidogrel
description: Study subjects diagnosed as stable, unstable ischemic coronary disease or myocardial infarction planning to undergo percutaneous coronary intervention (PCI) and no contradiction to prolonged DAPT are eligible for this trial. All subjects will provide written informed consent to participate. Subjects will be enrolled into the study before or within 24 hours after the index procedure. Subjects will be randomized to either discontinue P2Y12 inhibitor (clopidogrel or ticagrelor) (12 months total) or receive P2Y12 inhibitor for an additional 24 months (36 months total). Aspirin will be maintained in the entire study and can be replaced by cilostazol or indobufen if subjects are intolerant. Dosage of antiplatelet drugs will be according to local standard of practice. Subjects will be treated with XINSORB BRS only.
arm group label: prolonged DAPT group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Clopidogrel