<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/NCT03284827</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV 2017-08</org_study_id>
    <nct_id>NCT03284827</nct_id>
  </id_info>
  <brief_title>Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement</brief_title>
  <acronym>ADAPT-TAVR</acronym>
  <official_title>a Multicenter, Randomized, Open-label, Active-treatment, Controlled Trial to Compare the Efficacy of NOAC With Edoxaban vs. Dual Antiplatelet Therapy (DAPT) for Prevention of Leaflet Thrombosis (Documented by Cardiac CT Imaging) and Cerebral Embolization (Documented With Brain DW-MRI Imaging) in Patients Without an Absolute Indication for Chronic OAC After Successful TAVR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duk-Woo Park, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CardioVascular Research Foundation, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daiichi Sankyo Korea Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan 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 trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs.&#xD;
      dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac&#xD;
      CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic&#xD;
      resonance (MR) imaging) in patients without an absolute indication for chronic oral&#xD;
      anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Actual">November 5, 2021</completion_date>
  <primary_completion_date type="Actual">October 26, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>an incidence of leaflet thrombosis</measure>
    <time_frame>6-month</time_frame>
    <description>an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>6-month</time_frame>
    <description>all-cause, cardiovascular, or non-cardiovascular mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke or transient ischemic attack</measure>
    <time_frame>6-month</time_frame>
    <description>disabling or non-disabling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding event</measure>
    <time_frame>6-month</time_frame>
    <description>life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Echocardiographic parameter</measure>
    <time_frame>6-month</time_frame>
    <description>the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New lesion volume on MRI scans</measure>
    <time_frame>6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of neurological and neurocognitive function</measure>
    <time_frame>6-month</time_frame>
    <description>according to NeuroARC(Neuro Academic Research Consortium) definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of new lesions on brain DW-MRI scans</measure>
    <time_frame>6-month</time_frame>
    <description>the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>NOAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 mg once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NOAC</intervention_name>
    <description>edoxaban (60 mg once daily [OD]) for at least 6 months</description>
    <arm_group_label>NOAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT</intervention_name>
    <description>clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months</description>
    <arm_group_label>DAPT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 19 years of age or older with successful TAVR procedure&#xD;
&#xD;
               -  either native valve or valve-in-valve with any approved/marketed device&#xD;
&#xD;
               -  A successful TAVR is defined as device success according to the VARC-2 criteria:&#xD;
&#xD;
                    1. correct positioning of a single prosthetic heart valve into the proper&#xD;
                       anatomical location AND&#xD;
&#xD;
                    2. Intended performance of the prosthetic heart valve (no prosthesis- patient&#xD;
                       mismatch* and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt;3 m/s,&#xD;
                       no moderate or severe prosthetic valve regurgitation AND&#xD;
&#xD;
                    3. absence of periprocedural complications (any type of stroke,&#xD;
                       life-threatening bleeding, acute coronary artery obstruction requiring&#xD;
                       intervention, major vascular complication requiring intervention, unresolved&#xD;
                       acute valve thrombosis, or any requirement of a repeat procedure.&#xD;
&#xD;
          2. Patients who voluntarily participated in the written agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any atrial fibrillation with an indication for chronic OAC.&#xD;
&#xD;
          2. An ongoing indication for OAC or any other indication for continued treatment with any&#xD;
             OAC&#xD;
&#xD;
          3. Any ongoing indication for DAPT (recent acute coronary syndrome or PCI within 12&#xD;
             months)&#xD;
&#xD;
          4. Planned coronary or vascular intervention or major surgery&#xD;
&#xD;
          5. Clinically significant bleeding patients&#xD;
&#xD;
          6. The risk of bleeding increased due to the following reasons at the time of TAVR&#xD;
             procedure, i. history of gastrointestinal ulcers within 1 month ii. Malignant tumor&#xD;
             with high risk of bleeding iii. Brain or spinal cord injury within 1 month iv. History&#xD;
             of intracranial or intracerebral hemorrhage within 12 months v. Esophageal varices vi.&#xD;
             Arteriovenous malformation vii. Vascular aneurysms viii. Spinal cord vascular&#xD;
             abnormalities or intracerebral vascular abnormalities ix. Active bleeding x.&#xD;
             Hemoglobin level &lt;7.0 g/dL or platelet count ≤ 50,000 / mm3 xi. History of major&#xD;
             surgery within 1 month&#xD;
&#xD;
          7. Clinically overt stroke within the last 3 months&#xD;
&#xD;
          8. Moderate and severe hepatic impairment, and any hepatic disease associated with&#xD;
             coagulopathy&#xD;
&#xD;
          9. Severe renal impairment (CrCl by Cockcroft-Gault equation&lt;15 mL/min per 1.73 m2),&#xD;
             chronic dialysis, or post-TAVR unresolved acute kidney injury&#xD;
&#xD;
         10. Terminal illness with life expectancy &lt;6 months&#xD;
&#xD;
         11. Hypersensitivity to the main component or constituents of Edoxaban&#xD;
&#xD;
         12. Severe hypertensive patient&#xD;
&#xD;
         13. Patient who received prosthetic heart valve replacement for which anticoagulant&#xD;
             therapy is essential&#xD;
&#xD;
         14. Moderate to severe mitral stenosis&#xD;
&#xD;
         15. Pulmonary embolism requiring thrombolysis or pulmonary embolectomy&#xD;
&#xD;
         16. Patients who are actively participating in another drug or device investigational&#xD;
             study, which have not completed the primary endpoint follow-up period&#xD;
&#xD;
         17. Pregnancy test results are positive (all pregnant women should undergo urinary human&#xD;
             chorionic gonadotropin (hCG) testing within 7 days prior to screening and / or&#xD;
             randomization) or during pregnancy or lactation&#xD;
&#xD;
         18. Genetic problem with galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption&#xD;
&#xD;
         19. History of hypersensitivity to Edoxaban, Aspirin or clopidogrel&#xD;
&#xD;
         20. Current or history of Aspirin- or NSAIDs-induced asthma&#xD;
&#xD;
         21. Hemophilia&#xD;
&#xD;
         22. Patients who are using Methotrexate at doses of 15mg or more per week&#xD;
&#xD;
         23. Patients who have unsuitable condition to undergo Brain MRI(Magnetic resonance&#xD;
             imaging) and/or Cardiac CT(computed tomography) (e.g., tremor from Parkinson's&#xD;
             disease). This is at the discretion of investigators.&#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>Seung-jung Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiology, Asan Medical Center Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bundang CHA Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheng Hsin General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Duk-Woo Park, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>edoxaban</keyword>
  <keyword>dual antiplatelet therapy</keyword>
  <keyword>cerebral embolization</keyword>
  <keyword>leaflet thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03284827
org study id: AMCCV 2017-08
nct id: NCT03284827
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs.
      dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac
      CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic
      resonance (MR) imaging) in patients without an absolute indication for chronic oral
      anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: an incidence of leaflet thrombosis
time frame: 6-month
description: an incidence of leaflet thrombosis on four-dimensional, volume-rendered cardiac CT imaging
measure: Death
time frame: 6-month
description: all-cause, cardiovascular, or non-cardiovascular mortality
measure: Myocardial infarction
time frame: 6-month
measure: Stroke or transient ischemic attack
time frame: 6-month
description: disabling or non-disabling
measure: Bleeding event
time frame: 6-month
description: life-threatening or disabling, major bleeding, or minor bleeding according to VARC(The Valve Academic Research Consortium)-2 definition
measure: The change of Echocardiographic parameter
time frame: 6-month
description: the mean transaortic valve pressure gradient and velocity time integral ratio at baseline and 6-month follow-up
measure: New lesion volume on MRI scans
time frame: 6-month
measure: The change of neurological and neurocognitive function
time frame: 6-month
description: according to NeuroARC(Neuro Academic Research Consortium) definition
measure: the number of new lesions on brain DW-MRI scans
time frame: 6-month
description: the number of new lesions on brain DW-MRI scans at 6 months relative to immediate post-TAVR
arm group label: NOAC
arm group type: Experimental
description: 60 mg once daily
arm group label: DAPT
arm group type: Active Comparator
description: clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD)
intervention type: Drug
intervention name: NOAC
description: edoxaban (60 mg once daily [OD]) for at least 6 months
arm group label: NOAC
intervention type: Drug
intervention name: DAPT
description: clopidogrel (75 mg OD) plus acetylsalicylic acid (ASA, 75-100 mg OD) for at least 6 months
arm group label: DAPT
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Seung-jung Park, MD
role: Principal Investigator
affiliation: Cardiology, Asan Medical Center Heart Institute
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
country: Korea, Republic of
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Duk-Woo Park, MD
investigator title: Professor
mesh term: Thrombosis
mesh term: Aortic Valve Stenosis
sharing ipd: Undecided