<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/NCT03258645</url>
  </required_header>
  <id_info>
    <org_study_id>1160.235</org_study_id>
    <nct_id>NCT03258645</nct_id>
  </id_info>
  <brief_title>This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke</brief_title>
  <official_title>Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A Retrospective Analysis From the SITS-AF Registry on Treatment Initiation of Dabigatran Etexilate in Non-valvular Atrial Fibrillation Patients Hospitalized With Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SITS international registry, Karolinska University Hospital, Stockholm, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study in patients with non-valvular atrial fibrillation (NVAF)&#xD;
      presenting to the hospital with a first acute ischemic stroke based on existing data recorded&#xD;
      in the SITS International Registry (located in Sweden) by physicians in several European&#xD;
      countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain,&#xD;
      Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia,&#xD;
      Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.&#xD;
&#xD;
      The aim of this study is to explore the current real world use of dabigatran for stroke&#xD;
      prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European&#xD;
      patients registered in the SITS registry will be considered; countries of origin are not&#xD;
      known a priori.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Actual">June 17, 2019</completion_date>
  <primary_completion_date type="Actual">June 17, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)</measure>
    <time_frame>Up to 3 months of follow-up after index event</time_frame>
    <description>To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event) date, up to 1 day.</time_frame>
    <description>The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event) date, up to 1 day.</time_frame>
    <description>Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of Patients According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
    <description>Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (&gt;65 years), Drugs and Alcohol Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
    <description>Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
    <description>The Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAS-BLED of Patients According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
    <description>The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
    <description>Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.</measure>
    <time_frame>Up to 3 months of follow-up after index event.</time_frame>
    <description>Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period</measure>
    <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
    <description>Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians</measure>
    <time_frame>Up to 3 months of follow-up after index event.</time_frame>
    <description>Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians</measure>
    <time_frame>Up to 3 months of follow-up after index event.</time_frame>
    <description>Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1489</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Acute ischemic stroke</arm_group_label>
    <description>Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran</intervention_name>
    <description>Oral anticoagulant (NOAC) thrombin inhibitor</description>
    <arm_group_label>Acute ischemic stroke</arm_group_label>
    <other_name>Pradaxa</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1000&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients with non-valvular Atrial Fibrillation (NVAF)&#xD;
&#xD;
          -  Patients presenting with their first acute ischemic stroke&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Documentation that the patient was enrolled or is planned to be enrolled in an&#xD;
        investigational clinical trial at the time of the onset of the index event and for the&#xD;
        duration of the data collection&#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>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SITS International (c/o Karolinska University Hospital)</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>June 9, 2020</results_first_submitted>
  <results_first_submitted_qc>July 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2020</results_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dabigatran</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03258645/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03258645/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This retrospective study using existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry assessed the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation after the first ever ischemic stroke (3 months of follow-up thereafter) to prevent secondary stroke.</recruitment_details>
      <pre_assignment_details>In this non-interventional study based on existing data, no patients were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Total</title>
          <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1489"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1489"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry.</population>
      <group_list>
        <group group_id="B1">
          <title>Total</title>
          <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1489"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1489"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1489"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="788"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)</title>
        <description>To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.</description>
        <time_frame>Up to 3 months of follow-up after index event</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)</title>
          <description>To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 - 24 hours (h)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 24 - 72 h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 3 - 7 days (d)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 7 - 14 d</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 14 - 28 d</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 28 d - 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period</title>
        <description>The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.</description>
        <time_frame>At first ever ischaemic stroke (index event) date, up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period</title>
          <description>The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="5" upper_limit="14"/>
                    <measurement group_id="O2" value="8" lower_limit="5" upper_limit="14"/>
                    <measurement group_id="O3" value="8" lower_limit="6" upper_limit="13"/>
                    <measurement group_id="O4" value="12" lower_limit="7" upper_limit="17"/>
                    <measurement group_id="O5" value="14" lower_limit="10" upper_limit="18"/>
                    <measurement group_id="O6" value="15" lower_limit="9" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period</title>
        <description>Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.</description>
        <time_frame>At first ever ischaemic stroke (index event) date, up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period</title>
          <description>Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Age of Patients According to Dabigatran Initiation Time Period</title>
        <description>Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (&gt;65 years), Drugs and Alcohol Score.</description>
        <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Age of Patients According to Dabigatran Initiation Time Period</title>
          <description>Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (&gt;65 years), Drugs and Alcohol Score.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="11"/>
                    <measurement group_id="O2" value="74" spread="10"/>
                    <measurement group_id="O3" value="75" spread="9"/>
                    <measurement group_id="O4" value="75" spread="9"/>
                    <measurement group_id="O5" value="76" spread="9"/>
                    <measurement group_id="O6" value="77" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol Score.</non_inferiority_desc>
            <p_value>0.016</p_value>
            <method>Regression, Linear</method>
            <method_desc>Relation between age and dabigatran initiation time was reported.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.02</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period</title>
        <description>Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.</description>
        <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period</title>
          <description>Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>millimetre of mercury (mm Hg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="12"/>
                    <measurement group_id="O2" value="83" spread="15"/>
                    <measurement group_id="O3" value="84" spread="14"/>
                    <measurement group_id="O4" value="85" spread="15"/>
                    <measurement group_id="O5" value="85" spread="17"/>
                    <measurement group_id="O6" value="91" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol Score.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <method>Regression, Linear</method>
            <method_desc>Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period</title>
        <description>The Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.</description>
        <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period</title>
          <description>The Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="O2" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="O3" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="O4" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="O5" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="O6" value="5" lower_limit="4" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol Score.</non_inferiority_desc>
            <p_value>0.04</p_value>
            <method>Regression, Linear</method>
            <method_desc>Relation between CHA2DS2-VASc and dabigatran initiation time was reported.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HAS-BLED of Patients According to Dabigatran Initiation Time Period</title>
        <description>The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.</description>
        <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>HAS-BLED of Patients According to Dabigatran Initiation Time Period</title>
          <description>The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O3" value="3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O4" value="3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O5" value="3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O6" value="3" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol Score.</non_inferiority_desc>
            <p_value>0.051</p_value>
            <method>Regression, Linear</method>
            <method_desc>Relation between HAS-BLED and dabigatran initiation time was reported.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period</title>
        <description>Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.</description>
        <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period</title>
          <description>Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after hospitalization for first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran treatment initiation timing information only.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="344"/>
                <count group_id="O4" value="410"/>
                <count group_id="O5" value="174"/>
                <count group_id="O6" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="1.1"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="3.0"/>
                    <measurement group_id="O5" value="1.8"/>
                    <measurement group_id="O6" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol Score.</non_inferiority_desc>
            <p_value>0.026</p_value>
            <method>Regression, Linear</method>
            <method_desc>Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.</title>
        <description>Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
        <time_frame>Up to 3 months of follow-up after index event.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.</title>
          <description>Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
          <units>Times</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Haemorrhagic transformation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Haemorrhage (ICH) Spontaneous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity Infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size of Infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location Infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intervention used to treat ischemic stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Altered coagulation parameters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients bleeding risk factors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients stroke risk factors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommendation from specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Practical considerations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reason is not specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other reasons</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period</title>
        <description>Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
        <time_frame>At first ever ischaemic stroke (index event), up to 1 day.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
        <group_list>
          <group group_id="O1">
            <title>0 - 24 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time less than 24 hours following index event were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>&gt; 24 - 72 Hours</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 24 hours up to 72 hours following index event were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>&gt; 3 - 7 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 3 days up to 7 days following index event were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>&gt; 7 - 14 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 7 days up to 14 days following index event were included in this group.</description>
          </group>
          <group group_id="O5">
            <title>&gt; 14 - 28 Days</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 14 days up to 28 days following index event were included in this group.</description>
          </group>
          <group group_id="O6">
            <title>&gt; 28 Days - 3 Months</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.&#xD;
Only patients with dabigatran initiation time greater than 28 days up to 3 months following index event were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period</title>
          <description>Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
          <units>Times</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="42"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Haemorrhagic transformation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Haemorrhage (ICH) pontaneous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity Infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size of Infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location Infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intervention used to treat ischemic stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Altered coagulation parameters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients bleeding risk factors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients stroke risk factors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommendation from specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Practical considerations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reason is not specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other reasons</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians</title>
        <description>Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
        <time_frame>Up to 3 months of follow-up after index event.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians</title>
          <description>Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
          <units>Times</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="382"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Haemorrhagic transformation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Haemorrhage (ICH) spontaneous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity of stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size of infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location of infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intervention used to treat stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Altered coagulation parameters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients bleeding risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients stroke risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommendation from specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reason is not specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other reasons</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Co-medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Co-morbidities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians</title>
        <description>Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
        <time_frame>Up to 3 months of follow-up after index event.</time_frame>
        <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
        <group_list>
          <group group_id="O1">
            <title>Total</title>
            <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians</title>
          <description>Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.</description>
          <population>Patients with non-valvular atrial fibrillation who were initiating dabigatran after first ever ischaemic stroke to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke International Stroke Registry. Analysis was on patients with dabigatran initiation timing information and non-missing endpoint results.</population>
          <units>Times</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="475"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intracranial Haemorrhage (ICH) spontaneous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity of stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Size of infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Location of infarct</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intervention used to treat stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Altered coagulation parameters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients bleeding risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients stroke risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recommendation from specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reason is not specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other reasons</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Co-medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Co-morbidities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event information was not applicable for this study.</time_frame>
      <desc>As this is a observational study with existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry, safety monitoring and safety reporting on an individual case level is not applicable.</desc>
      <group_list>
        <group group_id="E1">
          <title>Total</title>
          <description>Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke based on existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry. Their follow-up period was around 3 months after the index event.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.&#xD;
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.&#xD;
BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This is an observational study on existing data. All findings are conditional on a selected sample of subjects who had initiated treatment prior to dying, having a second stroke or leaving care.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03258645
org study id: 1160.235
nct id: NCT03258645
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an observational study in patients with non-valvular atrial fibrillation (NVAF)
      presenting to the hospital with a first acute ischemic stroke based on existing data recorded
      in the SITS International Registry (located in Sweden) by physicians in several European
      countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain,
      Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia,
      Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.

      The aim of this study is to explore the current real world use of dabigatran for stroke
      prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European
      patients registered in the SITS registry will be considered; countries of origin are not
      known a priori.
observational model: Case-Only
time perspective: Retrospective
measure: Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)
time frame: Up to 3 months of follow-up after index event
description: To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.
measure: National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
description: The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.
measure: Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
description: Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.
measure: Age of Patients According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event), up to 1 day.
description: Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (>65 years), Drugs and Alcohol Score.
measure: Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event), up to 1 day.
description: Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
measure: CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event), up to 1 day.
description: The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.
measure: HAS-BLED of Patients According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event), up to 1 day.
description: The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.
measure: Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event), up to 1 day.
description: Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
measure: Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
time frame: Up to 3 months of follow-up after index event.
description: Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
measure: Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
time frame: At first ever ischaemic stroke (index event), up to 1 day.
description: Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
measure: Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
time frame: Up to 3 months of follow-up after index event.
description: Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
measure: Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
time frame: Up to 3 months of follow-up after index event.
description: Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
arm group label: Acute ischemic stroke
description: Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke
intervention type: Drug
intervention name: Dabigatran
description: Oral anticoagulant (NOAC) thrombin inhibitor
arm group label: Acute ischemic stroke
other name: Pradaxa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Sweden
url: https://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Dabigatran
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is an observational study on existing data. All findings are conditional on a selected sample of subjects who had initiated treatment prior to dying, having a second stroke or leaving care.
point of contact: 