<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/NCT04476147</url>
  </required_header>
  <id_info>
    <org_study_id>BFH - Frailty and thrombosis</org_study_id>
    <nct_id>NCT04476147</nct_id>
  </id_info>
  <brief_title>The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）</brief_title>
  <official_title>The Impact of Frailty on Thrombosis of Elderly Patients With Non-valvular Atrial Fibrillation (NVAF).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship 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>
      This study aims to investigate the use of anticoagulants in elderly patients with&#xD;
      non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with&#xD;
      NVAF. After two years follow-up, we observe the incidence of thrombotic events and the&#xD;
      influence of frailty on thrombotic events in elderly patients with NVAF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ischemic stroke</measure>
    <time_frame>24 months</time_frame>
    <description>Cerebral infarction, Transient ischemic attack, Cerebral embolism.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Massive hemorrhage</measure>
    <time_frame>24 months</time_frame>
    <description>Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause death</measure>
    <time_frame>24 months</time_frame>
    <description>All-cause death during the 2-year observation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis</condition>
  <arm_group>
    <arm_group_label>Participates</arm_group_label>
    <description>This is an observational study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.</intervention_name>
    <description>This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.</description>
    <arm_group_label>Participates</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The inhospital patients (≥65yr) with NVAF of Beijing Friendship Hospital, Capital Medical&#xD;
        University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥65yr&#xD;
&#xD;
          -  Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter&#xD;
&#xD;
          -  fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale&#xD;
&#xD;
          -  patients agreed and provided informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  valvular atrial fibrillation&#xD;
&#xD;
          -  cardiac surgery related atrial fibrillation&#xD;
&#xD;
          -  acute disease related atrial fibrillation&#xD;
&#xD;
          -  patients not fulfilled all the exam and text，or not accept the follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunli Xing, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongwei Li, Prof.</last_name>
    <phone>0086 10 63139780</phone>
    <email>lhw19656@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yunli Xing, Dr.</last_name>
    <phone>0086 10 63139595</phone>
    <email>xingyunli1976@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongwei Li</last_name>
      <phone>0086 10 63139780</phone>
      <email>lhw19656@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Xuhe Gong</last_name>
      <phone>0086 10 63139780</phone>
      <email>gongxuhe123@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Xing Y, Ma Q, Ma X, Wang C, Zhang D, Sun Y. CHADS2 score has a better predictive value than CHA2DS2-VASc score in elderly patients with atrial fibrillation. Clin Interv Aging. 2016 Jul 14;11:941-6. doi: 10.2147/CIA.S105360. eCollection 2016.</citation>
    <PMID>27478371</PMID>
  </reference>
  <reference>
    <citation>Xing YL, Ma Q, Ma XY, Wang CY, Zhou Z, Huang YS, Sun Y. Characteristics of non-valvular atrial fibrillation patients who benefit most from anticoagulation treatment. Int J Clin Exp Med. 2015 Oct 15;8(10):18721-8. eCollection 2015.</citation>
    <PMID>26770487</PMID>
  </reference>
  <reference>
    <citation>Fumagalli S, Said SAM, Laroche C, Gabbai D, Marchionni N, Boriani G, Maggioni AP, Popescu MI, Rasmussen LH, Crijns HJGM, Lip GYH; EORP-AF Investigators. Age-Related Differences in Presentation, Treatment, and Outcome of Patients With Atrial Fibrillation in Europe: The EORP-AF General Pilot Registry (EURObservational Research Programme-Atrial Fibrillation). JACC Clin Electrophysiol. 2015 Aug;1(4):326-334. doi: 10.1016/j.jacep.2015.02.019. Epub 2015 Apr 20.</citation>
    <PMID>29759321</PMID>
  </reference>
  <reference>
    <citation>Bo M, Li Puma F, Badinella Martini M, Falcone Y, Iacovino M, Grisoglio E, Bonetto M, Isaia G, Ciccone G, Isaia GC, Gaita F. Health status, geriatric syndromes and prescription of oral anticoagulant therapy in elderly medical in-patients with atrial fibrillation: a prospective observational study. Int J Cardiol. 2015;187:123-5. doi: 10.1016/j.ijcard.2015.03.334. Epub 2015 Mar 21. No abstract available.</citation>
    <PMID>25828331</PMID>
  </reference>
  <reference>
    <citation>Mazzone A, Bo M, Lucenti A, Galimberti S, Bellelli G, Annoni G. The role of comprehensive geriatric assessment and functional status in evaluating the patterns of antithrombotic use among older people with atrial fibrillation. Arch Gerontol Geriatr. 2016 Jul-Aug;65:248-54. doi: 10.1016/j.archger.2016.04.008. Epub 2016 Apr 13.</citation>
    <PMID>27131228</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Hongwei Li, MD</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_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/NCT04476147
org study id: BFH - Frailty and thrombosis
nct id: NCT04476147
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the use of anticoagulants in elderly patients with
      non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with
      NVAF. After two years follow-up, we observe the incidence of thrombotic events and the
      influence of frailty on thrombotic events in elderly patients with NVAF.
observational model: Cohort
time perspective: Prospective
measure: Ischemic stroke
time frame: 24 months
description: Cerebral infarction, Transient ischemic attack, Cerebral embolism.
measure: Massive hemorrhage
time frame: 24 months
description: Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc.
measure: All-cause death
time frame: 24 months
description: All-cause death during the 2-year observation
arm group label: Participates
description: This is an observational study
intervention type: Other
intervention name: Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.
description: This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.
arm group label: Participates
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Yunli Xing, Dr.
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Hongwei Li, Prof.
phone: 0086 10 63139780
email: lhw19656@sina.com
last name: Yunli Xing, Dr.
phone: 0086 10 63139595
email: xingyunli1976@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Xing Y, Ma Q, Ma X, Wang C, Zhang D, Sun Y. CHADS2 score has a better predictive value than CHA2DS2-VASc score in elderly patients with atrial fibrillation. Clin Interv Aging. 2016 Jul 14;11:941-6. doi: 10.2147/CIA.S105360. eCollection 2016.
PMID: 27478371
citation: Xing YL, Ma Q, Ma XY, Wang CY, Zhou Z, Huang YS, Sun Y. Characteristics of non-valvular atrial fibrillation patients who benefit most from anticoagulation treatment. Int J Clin Exp Med. 2015 Oct 15;8(10):18721-8. eCollection 2015.
PMID: 26770487
citation: Fumagalli S, Said SAM, Laroche C, Gabbai D, Marchionni N, Boriani G, Maggioni AP, Popescu MI, Rasmussen LH, Crijns HJGM, Lip GYH; EORP-AF Investigators. Age-Related Differences in Presentation, Treatment, and Outcome of Patients With Atrial Fibrillation in Europe: The EORP-AF General Pilot Registry (EURObservational Research Programme-Atrial Fibrillation). JACC Clin Electrophysiol. 2015 Aug;1(4):326-334. doi: 10.1016/j.jacep.2015.02.019. Epub 2015 Apr 20.
PMID: 29759321
citation: Bo M, Li Puma F, Badinella Martini M, Falcone Y, Iacovino M, Grisoglio E, Bonetto M, Isaia G, Ciccone G, Isaia GC, Gaita F. Health status, geriatric syndromes and prescription of oral anticoagulant therapy in elderly medical in-patients with atrial fibrillation: a prospective observational study. Int J Cardiol. 2015;187:123-5. doi: 10.1016/j.ijcard.2015.03.334. Epub 2015 Mar 21. No abstract available.
PMID: 25828331
citation: Mazzone A, Bo M, Lucenti A, Galimberti S, Bellelli G, Annoni G. The role of comprehensive geriatric assessment and functional status in evaluating the patterns of antithrombotic use among older people with atrial fibrillation. Arch Gerontol Geriatr. 2016 Jul-Aug;65:248-54. doi: 10.1016/j.archger.2016.04.008. Epub 2016 Apr 13.
PMID: 27131228
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Hongwei Li, MD
investigator title: Prof.
mesh term: Atrial Fibrillation
mesh term: Thrombosis
mesh term: Frailty