<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/NCT03828162</url>
  </required_header>
  <id_info>
    <org_study_id>OAC and elderly</org_study_id>
    <nct_id>NCT03828162</nct_id>
  </id_info>
  <brief_title>Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly</brief_title>
  <acronym>Carebbean-e</acronym>
  <official_title>Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (&gt;=75 Years)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to assess the effectiveness of oral anticoagulants in elderly&#xD;
      patients (&gt;=75 years) with atrial fibrillation. All patients discharged from one large&#xD;
      hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017&#xD;
      with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events&#xD;
      (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non&#xD;
      fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to&#xD;
      mandatory and qualitative national registries and review of the medical records until&#xD;
      december 31 2018.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators established a prospective cohort of 2943 of elderly (&gt;=75 years old)&#xD;
      discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st&#xD;
      2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital.&#xD;
      Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial&#xD;
      fibrillation and atrial flutter) according to the International Classification of Diseases,&#xD;
      10th revision. The first admission to the hospital during the study period is recorded as the&#xD;
      index admission.&#xD;
&#xD;
      Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at&#xD;
      admission and at discharge have been recorded for each patient through the screening of&#xD;
      medical journals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2010</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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 and peripheral embolism</measure>
    <time_frame>2011-11-01 to 2018-12-31</time_frame>
    <description>Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding requiring hospitalization</measure>
    <time_frame>2011-11-01 to 2018-12-31</time_frame>
    <description>Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029).&#xD;
Data are extracted from the swedish national patients register.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>2011-11-01 to 2018-12-31</time_frame>
    <description>Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute coronary syndrome</measure>
    <time_frame>2011-11-01 to 2018-12-31</time_frame>
    <description>Acute coronary syndrome have been defined according to the International Classification of Diseases (ICD-10) by the codes: I20-I24.&#xD;
Data are extracted from the swedish national patients register.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Heart failure</measure>
    <time_frame>2011-11-01 to 2018-12-31</time_frame>
    <description>Heart failure has been defined according to the International Classification of Diseases (ICD-10) by the code: I50.&#xD;
Data are extracted from the swedish national patients register.</description>
  </other_outcome>
  <enrollment type="Actual">2943</enrollment>
  <condition>Anticoagulants Causing Adverse Effects in Therapeutic Use</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Frail Elderly Syndrome</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anticoagulants</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective cardiovascular cohort&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All consecutive patients discharged with atrial fibrillation as main diagnosis from&#xD;
        Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have not given their consensus to the use of medical journals for&#xD;
             register based research.&#xD;
&#xD;
          -  Patients who were discharged from the hospital with atrial fibrillation as main&#xD;
             diagnosis but were admitted to the hospital for medical reasons unrelated to atrial&#xD;
             fibrillation (as an example change of pacemakers batteries).&#xD;
&#xD;
          -  Patients whose medical records are not consistent with the main diagnosis (as an&#xD;
             example wrong ICD code).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruna Gigante, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Bruna Gigante</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared according to the rules on privacy at Karolinska Institutet and according to General Data Protection Regulations in Europe.&#xD;
Individual data will not be shared, but summary statistics of the variable of interest will be provided upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>from January 2020</ipd_time_frame>
  </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/NCT03828162
org study id: OAC and elderly
nct id: NCT03828162
lead sponsor: 
has dmc: No
is fda regulated drug: No
This study was designed to assess the effectiveness of oral anticoagulants in elderly
      patients (>=75 years) with atrial fibrillation. All patients discharged from one large
      hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017
      with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events
      (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non
      fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to
      mandatory and qualitative national registries and review of the medical records until
      december 31 2018.
The investigators established a prospective cohort of 2943 of elderly (>=75 years old)
      discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st
      2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital.
      Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial
      fibrillation and atrial flutter) according to the International Classification of Diseases,
      10th revision. The first admission to the hospital during the study period is recorded as the
      index admission.

      Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at
      admission and at discharge have been recorded for each patient through the screening of
      medical journals.
observational model: Cohort
time perspective: Prospective
measure: Ischemic stroke and peripheral embolism
time frame: 2011-11-01 to 2018-12-31
description: Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.
measure: Bleeding requiring hospitalization
time frame: 2011-11-01 to 2018-12-31
description: Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029).
Data are extracted from the swedish national patients register.
measure: Cardiovascular death
time frame: 2011-11-01 to 2018-12-31
description: Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.
measure: Acute coronary syndrome
time frame: 2011-11-01 to 2018-12-31
description: Acute coronary syndrome have been defined according to the International Classification of Diseases (ICD-10) by the codes: I20-I24.
Data are extracted from the swedish national patients register.
measure: Heart failure
time frame: 2011-11-01 to 2018-12-31
description: Heart failure has been defined according to the International Classification of Diseases (ICD-10) by the code: I50.
Data are extracted from the swedish national patients register.
intervention type: Drug
intervention name: Anticoagulants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Bruna Gigante, MD PhD
role: Principal Investigator
affiliation: Karolinska Institutet
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Bruna Gigante
investigator title: Associate professor
mesh term: Atrial Fibrillation
mesh term: Anticoagulants
sharing ipd: Yes
ipd description: Data will be shared according to the rules on privacy at Karolinska Institutet and according to General Data Protection Regulations in Europe.
Individual data will not be shared, but summary statistics of the variable of interest will be provided upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: from January 2020