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/NCT06007222</url>
    </required_header>
    <id_info>
      <org_study_id>NAPT trial</org_study_id>
      <nct_id>NCT06007222</nct_id>
    </id_info>
    <brief_title>Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial</brief_title>
    <official_title>Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>OCEAN-SHD Study Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>OCEAN-SHD Study Group</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and&#xD;
        continued aspirin 100mg/day the end of the study period.&#xD;
  &#xD;
        Non-antithrombotic group: No antithrombotic agents will be administered after randomization&#xD;
        until the end of the study period.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Primary endpoint</measure>
      <time_frame>minimum 1 year, maximum 3 years of follow-up</time_frame>
      <description>Composite endpoint consisting of all-cause deaths, myocardial infarction, stroke from any cause and bleeding from randomization to end of study&#xD;
  The outcomes of this study will comply with the Valve Academic Research Consortium 3 (VARC 3). VARC 3 Type 1, Type 2, Type 3, and Type 4 bleeding are all included as bleeding. In this study, the study subjects will be randomized after it has been confirmed that there were no perioperative complications, so it is essentially assumed that there will be no procedure-related bleeding.&#xD;
  Surviving subjects for whom the event does not occur will be censored as of the date the study treatment is discontinued or as of the last confirmed date of survival.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Key Secondary endpoint</measure>
      <time_frame>minimum 1 year, maximum 3 years of follow-up</time_frame>
      <description>Bleeding Events from Randomization to Study End. Cardiovascular adverse events from randomization until the end of the study (composite endpoint comprised of cardiovascular death, myocardial infarction, or CVA).&#xD;
  The definition of censoring for survival time analysis is the same as that used for the primary endpoint.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Aortic Stenosis</condition>
    <condition>TAVI(Transcatheter Aortic Valve Implantation)</condition>
    <condition>Aspirin</condition>
    <condition>DAPT(Dual Antiplatelet Therapy)</condition>
    <condition>SAPT(Single Antiplatelet Therapy)</condition>
    <arm_group>
      <arm_group_label>Aspirin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-antithrombotic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>No antithrombotic agents will be administered after randomization until the end of the study period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aspirin group</intervention_name>
      <description>Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.</description>
      <arm_group_label>Aspirin group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Non-antithrombotic group</intervention_name>
      <description>No antithrombotic agents will be administered after randomization until the end of the study period.</description>
      <arm_group_label>Non-antithrombotic group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who underwent transfemoral TAVI for aortic stenosis&#xD;
  &#xD;
            2. Patients aged 20 years or older at the time of informed consent&#xD;
  &#xD;
            3. Patients who have a thorough understanding of the subject of the study and who have&#xD;
               agreed in writing to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those with perioperative complications at the time of TAVI (conversion to open heart&#xD;
               surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular&#xD;
               dissection, cerebral infarction/cerebral hemorrhage, new atrial fibrillation, new&#xD;
               atrioventricular block)&#xD;
  &#xD;
            2. Individuals requiring antiplatelet agents for reasons other than TAVI (history of&#xD;
               myocardial infraction, history of PCI（Percutaneous Coronary Intervention）, history of&#xD;
               EVT（EndoVascular Treatment）, history of cerebral infraction and transient ischaemic&#xD;
               stroke, with significant coronary artery narrowing, with high-grade carotid artery&#xD;
               narrowing, and others judged as requiring antiplatelet therapy by the chief researcher&#xD;
               or a sub-investigator)&#xD;
  &#xD;
            3. Patients requiring oral anticoagulants (patients with atrial fibrillation, history of&#xD;
               pulmonary embolism or deep venous thrombosis, and other patients who are deemed to&#xD;
               require anticoagulation therapy by the investigator or coinvestigator)&#xD;
  &#xD;
            4. Patients with eGFR（estimated Glomerular Filtration Rate） &lt;30 and patients on&#xD;
               hemodialysis/peritoneal dialysis.&#xD;
  &#xD;
            5. Patients with a history of valve replacement in the heart valves.&#xD;
  &#xD;
            6. Patients who are pregnant, have childbearing potential, wish to become pregnant, or&#xD;
               are breastfeeding.&#xD;
  &#xD;
            7. Patients who have a concomitant medical illness associated with expected survival less&#xD;
               than one year.&#xD;
  &#xD;
            8. Patients who have the contraindications for aspirin.&#xD;
  &#xD;
            9. Patients with a diagnosis of severe allergy to aspirin or a history of&#xD;
               hypersensitivity.&#xD;
  &#xD;
           10. Patients requiring a legally acceptable representative, patients unable to obtain&#xD;
               written informed consent, or patients unable to understand the outline or purpose of&#xD;
               the study.&#xD;
  &#xD;
           11. Other patients for whom the principal investigator or the coinvestigator judges the&#xD;
               participation in the study inappropriate.&#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>Yosuke Sawa</last_name>
      <role>Study Director</role>
      <affiliation>EPS Corporation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yosuke Sawa</last_name>
      <phone>07024924466</phone>
      <email>sawa.yosuke872@eps.co.jp</email>
    </overall_contact>
    <location>
      <facility>
        <name>Keio University Hospital</name>
        <address>
          <city>Shinjuku</city>
          <state>Tokyo</state>
          <zip>160-8582</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kentaro Hayashida</last_name>
        <phone>03-5843-6702</phone>
        <email>khayashida.z6@keio.jp</email>
      </contact>
      <investigator>
        <last_name>Yuya Adachi</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tetsuro Shimura</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Masanori Yamamoto</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Minoru Tabata</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hiroshi Ueno</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hiroto Suzuyama</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Masahiko Asami</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Shinichi Shirai</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yusuke Watanabe</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Masahiro Yamawaki</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Norio Tada</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Futoshi Yamanaka</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yohei Ohno</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Masaki Izumo</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kazumasa Yamasaki</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hidetaka Nishina</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yasushi Fuku</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kazuki Mizutani</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fumiaki Yashima</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Aortic Valve Stenosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06007222
  org study id: NAPT trial
  nct id: NCT06007222
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and
        continued aspirin 100mg/day the end of the study period.
  
        Non-antithrombotic group: No antithrombotic agents will be administered after randomization
        until the end of the study period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary endpoint
  time frame: minimum 1 year, maximum 3 years of follow-up
  description: Composite endpoint consisting of all-cause deaths, myocardial infarction, stroke from any cause and bleeding from randomization to end of study
  The outcomes of this study will comply with the Valve Academic Research Consortium 3 (VARC 3). VARC 3 Type 1, Type 2, Type 3, and Type 4 bleeding are all included as bleeding. In this study, the study subjects will be randomized after it has been confirmed that there were no perioperative complications, so it is essentially assumed that there will be no procedure-related bleeding.
  Surviving subjects for whom the event does not occur will be censored as of the date the study treatment is discontinued or as of the last confirmed date of survival.
  measure: Key Secondary endpoint
  time frame: minimum 1 year, maximum 3 years of follow-up
  description: Bleeding Events from Randomization to Study End. Cardiovascular adverse events from randomization until the end of the study (composite endpoint comprised of cardiovascular death, myocardial infarction, or CVA).
  The definition of censoring for survival time analysis is the same as that used for the primary endpoint.
  arm group label: Aspirin group
  arm group type: Active Comparator
  description: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
  arm group label: Non-antithrombotic group
  arm group type: Experimental
  description: No antithrombotic agents will be administered after randomization until the end of the study period.
  intervention type: Drug
  intervention name: Aspirin group
  description: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
  arm group label: Aspirin group
  intervention type: Drug
  intervention name: Non-antithrombotic group
  description: No antithrombotic agents will be administered after randomization until the end of the study period.
  arm group label: Non-antithrombotic group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yosuke Sawa
  role: Study Director
  affiliation: EPS Corporation
  last name: Yosuke Sawa
  phone: 07024924466
  email: sawa.yosuke872@eps.co.jp
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
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  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
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  investigator: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  mesh term: Aspirin