<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/NCT04502017</url>
  </required_header>
  <id_info>
    <org_study_id>TCAI_LAAO</org_study_id>
    <nct_id>NCT04502017</nct_id>
  </id_info>
  <brief_title>Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion</brief_title>
  <acronym>FADE-DRT</acronym>
  <official_title>Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Cardiac Arrhythmia Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Cardiac Arrhythmia Research Foundation</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>
      Comparison among three different antithrombotic strategies after percutaneous LAA occlusion&#xD;
      with a Watchman FLX LAAC device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage&#xD;
      (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes&#xD;
      6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg)&#xD;
      and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued&#xD;
      indefinitely. Nonetheless, a significant number of patients continues to suffer from&#xD;
      device-related thrombosis which carries a high risk of thromboembolic events. Other AT&#xD;
      strategies have been tested in order to reduce the risk of thrombus-formation on device.&#xD;
      Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients&#xD;
      with genetic resistance to this drug has been recently reported to reduce the incidence of&#xD;
      DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin&#xD;
      generation compared to DAPT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Composite of Stroke, Systemic Embolism, and Device-related Thrombosis</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Major Bleeding Events</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Minor Bleeding Events</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Device-Related Thrombosis</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Left Atrial Appendage Occlusion</condition>
  <arm_group>
    <arm_group_label>Standard Antithrombotic Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genetic-Tailored AntiThrombotic Strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Half-Dose NOAC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Half Dose of Novel OAC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASA plus Clopidogrel</intervention_name>
    <description>OAC (6 weeks) + DAPT (until 6 months) + ASA</description>
    <arm_group_label>Standard Antithrombotic Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genetic-Tailored AntiThrombotic Strategy</intervention_name>
    <description>Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype</description>
    <arm_group_label>Genetic-Tailored AntiThrombotic Strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Half-Dose of novel OAC</intervention_name>
    <description>Half Dose of novel OAC post-device Implantation</description>
    <arm_group_label>Half-Dose NOAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ≥18 years of age&#xD;
&#xD;
          -  Successful LAAC procedure (device implanted without procedural or bleeding&#xD;
             complication).&#xD;
&#xD;
          -  Patients contraindicated or unsuitable for long-term OAC.&#xD;
&#xD;
          -  History of AF (permanent or persistent or paroxysmal).&#xD;
&#xD;
          -  Written informed consent by the patient or designee if the patient is unable to&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt; 2 years.&#xD;
&#xD;
          -  Pregnant, breastfeeding, or unwilling to practice birth control during participation&#xD;
             in the study.&#xD;
&#xD;
          -  Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the patient or the quality of the data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Domenico G Della Rocca, MD</last_name>
    <phone>7375296806</phone>
    <email>domenicodellarocca@hotmail.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Natale, MD</last_name>
    <phone>5127842651</phone>
    <email>andrea.natale@stdavids.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. David's Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Natale, MD</last_name>
      <email>andrea.natale@stdavids.com</email>
    </contact>
    <contact_backup>
      <last_name>Domenico G Della Rocca, MD</last_name>
      <phone>7375296806</phone>
      <email>domenicodellarocca@hotmail.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 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 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Cardiac Arrhythmia Research Foundation</investigator_affiliation>
    <investigator_full_name>Andrea Natale</investigator_full_name>
    <investigator_title>Executive Medical Director</investigator_title>
  </responsible_party>
  <keyword>left atrial appendage</keyword>
  <keyword>Watchman</keyword>
  <keyword>antithrombotic therapy</keyword>
  <keyword>device-related thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04502017
org study id: TCAI_LAAO
nct id: NCT04502017
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion
      with a Watchman FLX LAAC device.
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage
      (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes
      6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg)
      and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued
      indefinitely. Nonetheless, a significant number of patients continues to suffer from
      device-related thrombosis which carries a high risk of thromboembolic events. Other AT
      strategies have been tested in order to reduce the risk of thrombus-formation on device.
      Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients
      with genetic resistance to this drug has been recently reported to reduce the incidence of
      DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin
      generation compared to DAPT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
time frame: 1 year
measure: Incidence of Major Bleeding Events
time frame: 1 year
measure: Incidence of Minor Bleeding Events
time frame: 1 year
arm group label: Standard Antithrombotic Therapy
arm group type: Active Comparator
description: OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone
arm group label: Genetic-Tailored AntiThrombotic Strategy
arm group type: Active Comparator
description: OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone
arm group label: Half-Dose NOAC
arm group type: Active Comparator
description: Half Dose of Novel OAC
intervention type: Drug
intervention name: ASA plus Clopidogrel
description: OAC (6 weeks) + DAPT (until 6 months) + ASA
arm group label: Standard Antithrombotic Therapy
intervention type: Drug
intervention name: Genetic-Tailored AntiThrombotic Strategy
description: Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
arm group label: Genetic-Tailored AntiThrombotic Strategy
intervention type: Drug
intervention name: Half-Dose of novel OAC
description: Half Dose of novel OAC post-device Implantation
arm group label: Half-Dose NOAC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Domenico G Della Rocca, MD
phone: 7375296806
email: domenicodellarocca@hotmail.it
last name: Andrea Natale, MD
phone: 5127842651
email: andrea.natale@stdavids.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Cardiac Arrhythmia Research Foundation
investigator full name: Andrea Natale
investigator title: Executive Medical Director
mesh term: Atrial Fibrillation
mesh term: Thrombosis
mesh term: Clopidogrel
sharing ipd: No