<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/NCT03753490</url>
  </required_header>
  <id_info>
    <org_study_id>1011455</org_study_id>
    <nct_id>NCT03753490</nct_id>
  </id_info>
  <brief_title>ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study</brief_title>
  <acronym>ABC-AF</acronym>
  <official_title>ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish Foundation for Strategic Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swedish Heart Lung Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roche Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Swedish Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uppsala University</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>
      The primary study objective is to evaluate if personalized treatment by decision support,&#xD;
      based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the&#xD;
      occurrence of the composite outcome of stroke or death in patients with atrial fibrillation.&#xD;
      Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or&#xD;
      standard care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 25, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</primary_completion_date>
  <phase>N/A</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>Composite of Stroke or Death</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Bleeding</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Failure</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economics</measure>
    <time_frame>From the date of enrolment through study completion, minimum follow-up 2 years.</time_frame>
    <description>Mean differences in health care cost, and 2-year quality-adjusted survival based on EuroQol-5D-5L between the treatment groups, combined into an incremental cost-effectiveness ratio.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3933</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>ABC score guided therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Individual treatment recommendations based on the ABC-scores for stroke and bleeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Management according to local practice, national and international guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ABC score guided therapy</intervention_name>
    <description>In the ABC arm, individual treatment recommendations based on the ABC-scores for stroke and bleeding including non-vitamin K oral anticoagulant or no anticoagulant treatment, and other drugs and interventions, to improve stroke free survival.</description>
    <arm_group_label>ABC score guided therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>In the standard care arm, management according to local practice, national and international guidelines, including the potential use of traditional clinical risk scores for stroke and/or bleeding, anticoagulant treatment and other treatments and interventions.</description>
    <arm_group_label>Standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or&#xD;
             without current oral anticoagulant treatment&#xD;
&#xD;
          2. Signed informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)&#xD;
&#xD;
          2. Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous&#xD;
             thromboembolism and/or mechanical heart valve prosthesis&#xD;
&#xD;
          3. Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) and&#xD;
             not eligible for change of NOAC drug e.g. drug-drug interactions&#xD;
&#xD;
          4. Concomitant dual antiplatelet treatment&#xD;
&#xD;
          5. Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30&#xD;
             days&#xD;
&#xD;
          6. Participation in anti-thrombotic pharmaceutical trial&#xD;
&#xD;
          7. Planned for AF ablation or AF surgery&#xD;
&#xD;
          8. Haemoglobin &lt;90 g/L&#xD;
&#xD;
          9. Patients who, in the opinion of the investigator, cannot or will not comply with the&#xD;
             requirements of the protocol&#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_official>
    <last_name>Jonas Oldgren, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Uppsala Clinical Reseach Center, UCR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>Atrial Fibrillation</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/NCT03753490
org study id: 1011455
nct id: NCT03753490
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary study objective is to evaluate if personalized treatment by decision support,
      based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the
      occurrence of the composite outcome of stroke or death in patients with atrial fibrillation.
      Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or
      standard care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite of Stroke or Death
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Major Bleeding
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Stroke
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Death
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Myocardial Infarction
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Heart Failure
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Health Economics
time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
description: Mean differences in health care cost, and 2-year quality-adjusted survival based on EuroQol-5D-5L between the treatment groups, combined into an incremental cost-effectiveness ratio.
arm group label: ABC score guided therapy
arm group type: Other
description: Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
arm group label: Standard care
arm group type: Other
description: Management according to local practice, national and international guidelines.
intervention type: Other
intervention name: ABC score guided therapy
description: In the ABC arm, individual treatment recommendations based on the ABC-scores for stroke and bleeding including non-vitamin K oral anticoagulant or no anticoagulant treatment, and other drugs and interventions, to improve stroke free survival.
arm group label: ABC score guided therapy
intervention type: Other
intervention name: Standard care
description: In the standard care arm, management according to local practice, national and international guidelines, including the potential use of traditional clinical risk scores for stroke and/or bleeding, anticoagulant treatment and other treatments and interventions.
arm group label: Standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonas Oldgren, MD, PhD
role: Study Director
affiliation: Uppsala Clinical Reseach Center, UCR
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Atrial Fibrillation