<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/NCT03247036</url>
  </required_header>
  <id_info>
    <org_study_id>4R17/017</org_study_id>
    <secondary_id>17/034 Codi IDIAP: 4R17/017</secondary_id>
    <nct_id>NCT03247036</nct_id>
  </id_info>
  <brief_title>Long-Term Survival After Ischaemic Stroke: Ebrictus Study</brief_title>
  <acronym>EBRICTUS</acronym>
  <official_title>Long Survival After Ischemic Stroke and Thombolysis in Catalonia. Differences by Sex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but&#xD;
      there are gender differences. The authors sought to examine the relationship between sex and&#xD;
      outcome after thrombolysis.&#xD;
&#xD;
      Previous reports [1-6] concerning sex-related differences in stroke management and outcome&#xD;
      are inconsistent and sometimes difficult to interpret, and so the reasons for gender&#xD;
      disparities in stroke outcome have remained unclear. Functional outcomes and quality of life&#xD;
      after stroke are consistently poorer in women despite adjustment for baseline differences in&#xD;
      age and prestroke function, and the fact that comorbidities and clinical outcomes were not&#xD;
      different between women and men [3, 7] . Once the reasons for these differences are better&#xD;
      understood, intervention might be possible to help provide the best care for all patients.&#xD;
      This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has&#xD;
      suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11]&#xD;
      .The authors will explore whether sex might modify the effect of thrombolysis on survival and&#xD;
      functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated&#xD;
      time period of 6 months after stroke and compared this with the group without thrombolytic&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a reprospective, observational cohort study including incident strokes from January&#xD;
      1, 2011 to December 31, 2012 and followed up in December 31, 2016. Statistical approaches are&#xD;
      used to analyze survival outcomes. It is a longitudinal study of a population-based cohort of&#xD;
      all registered cases of a first episode of stroke that occurred in Catalonia (Spain).&#xD;
      Demographic Patterns and Epidemic Characteristics. Life expectancy at birth is 81.34 years&#xD;
      globally, 78.26 years for men and 84.74 years for women.&#xD;
&#xD;
      Case Definition The definition of stroke corresponds to that set by the World Health&#xD;
      Organization.&#xD;
&#xD;
      Patients were included by using the automated operation of the database of patients with a&#xD;
      diagnosis code of stroke (I60-I69).&#xD;
&#xD;
      The inclusion criteria were: age ≥ 15 up to ≤ 90; a diagnosis of stroke explicitly recorded&#xD;
      in their medical record at any of the registration systems in the health centers; it should&#xD;
      be a first stroke episode, and relevant episode information should be available in clinical&#xD;
      records: (a) outpatient clinic, (b) hospital clinic, or (c) access to medical/sociosanitary&#xD;
      reports.&#xD;
&#xD;
      The variables on which information was collected were grouped as follows: sociodemographic;&#xD;
      clinics: type (ischemic or hemorrhagic stroke) and event date (day/month/year); NIHSS score&#xD;
      on admission; whether or not there was thrombolytic therapy; duration of hospital stay;&#xD;
      hospital discharge destination (home, higher-level acute hospital, long-term care hospital,&#xD;
      death and date thereof); pre- and poststroke functional autonomy [the Barthel score was&#xD;
      classified as follows: &lt;20 (total dependence), 20-35 (severe dependence), 40-55 (moderate&#xD;
      dependence), ≥ 60 (mild dependence), or 100 (independence) registered for preepisode and for&#xD;
      discharge in the medical history of the patient, the hospital, or the primary care center];&#xD;
      functional status of the patient at discharge: death, home-autonomous, home address&#xD;
      caregiver, referral to another acute hospital, or convalescent center (temporary or long-term&#xD;
      stay), and vital status (alive/dead) of the patient, specifying the date (day/month/year) of&#xD;
      death, if any.&#xD;
&#xD;
      Statistical Analysis Computerized statistical analysis was undertaken with the following: (1)&#xD;
      descriptive basic statistics and standard deviation of key variables stratified by age and&#xD;
      sex and (2) differences in functional outcome and its evolution before and after the episode&#xD;
      determined the possible effects on mortality and different residual deficits categorized with&#xD;
      the statistical Cox regression model. Mortality should be interpreted as overall mortality&#xD;
      and cause-specific, no stroke. Patients who died during hospitalization or within the 1st&#xD;
      month are considered 'immediate death'. During follow-up the deceased are described as&#xD;
      'subsequent mortality'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">August 5, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Death all causes</measure>
    <time_frame>January 1, 2011 to December 31, 2016</time_frame>
    <description>Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.</description>
  </primary_outcome>
  <enrollment type="Actual">21000</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Thrombolytic (t-PA) Treatment</condition>
  <condition>Gender Bias</condition>
  <condition>Long Term Adverse Effects</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV thrombolytic (t-PA) treatment vs not</intervention_name>
    <description>Acute Stroke Protocol</description>
    <other_name>IV thrombolysis</other_name>
    <other_name>IV thrombolytic (t-PA) treatment</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were included by using the automated operation of the database of patients with a&#xD;
        diagnosis code of stroke (I60-I69).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 15 up to ≤ 90;&#xD;
&#xD;
          -  usual residence in Catalonia&#xD;
&#xD;
          -  and/or assignment to any of the catalonian primary care centers for 5 years at the&#xD;
             time of the stroke episode;&#xD;
&#xD;
          -  a diagnosis of stroke explicitly recorded in their medical record at any of the&#xD;
             registration systems in the health centers of the area; it should be a first stroke&#xD;
             episode, and relevant episode information should be available in clinical records: (a)&#xD;
             outpatient clinic, (b)hospital clinic, or (c) access to medical/sociosanitary reports.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intracerebral haemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Plan Director Enfermedad Vascular Cerebral</name>
      <address>
        <city>Barcelona</city>
        <zip>08005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, Gonzalez-Henares MA, Panisello-Tafalla A, Lopez-Pablo C, Lucas-Noll J; Ebrictus Group. Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study. Cerebrovasc Dis Extra. 2015 Oct 9;5(3):95-102. doi: 10.1159/000440734. eCollection 2015 Sep-Dec.</citation>
    <PMID>26648964</PMID>
  </reference>
  <reference>
    <citation>Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, Gonzalez-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten Primaria. 2015 Feb;47(2):108-16. doi: 10.1016/j.aprim.2014.04.008. Epub 2014 Jun 19. Spanish.</citation>
    <PMID>24953174</PMID>
  </reference>
  <reference>
    <citation>Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.</citation>
    <PMID>27113062</PMID>
  </reference>
  <results_reference>
    <citation>Clua-Espuny JL, Abilleira S, Queralt-Tomas L, Gonzalez-Henares A, Gil-Guillen V, Muria-Subirats E, Ballesta-Ors J. Long-Term Survival After Stroke According to Reperfusion Therapy, Cardiovascular Therapy and Gender. Cardiol Res. 2019 Apr;10(2):89-97. doi: 10.14740/cr839. Epub 2019 Apr 11.</citation>
    <PMID>31019638</PMID>
  </results_reference>
  <results_reference>
    <citation>Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen FV, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J. [The stroke care system in Terres de l'Ebre, Spain, after the implementation of the Stroke Code model: Ebrictus Study]. Med Clin (Barc). 2012 May 19;138(14):609-11. doi: 10.1016/j.medcli.2011.10.004. Epub 2011 Dec 6. Spanish.</citation>
    <PMID>22153783</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>April 3, 2022</last_update_submitted>
  <last_update_submitted_qc>April 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</investigator_affiliation>
    <investigator_full_name>Josep Lluís Clua Espuny</investigator_full_name>
    <investigator_title>PhD Family and Community Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Long Term Adverse Effects</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrinolytic Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Dates files</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03247036
org study id: 4R17/017
secondary id: 17/034 Codi IDIAP: 4R17/017
nct id: NCT03247036
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but
      there are gender differences. The authors sought to examine the relationship between sex and
      outcome after thrombolysis.

      Previous reports [1-6] concerning sex-related differences in stroke management and outcome
      are inconsistent and sometimes difficult to interpret, and so the reasons for gender
      disparities in stroke outcome have remained unclear. Functional outcomes and quality of life
      after stroke are consistently poorer in women despite adjustment for baseline differences in
      age and prestroke function, and the fact that comorbidities and clinical outcomes were not
      different between women and men [3, 7] . Once the reasons for these differences are better
      understood, intervention might be possible to help provide the best care for all patients.
      This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has
      suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11]
      .The authors will explore whether sex might modify the effect of thrombolysis on survival and
      functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated
      time period of 6 months after stroke and compared this with the group without thrombolytic
      treatment.
This is a reprospective, observational cohort study including incident strokes from January
      1, 2011 to December 31, 2012 and followed up in December 31, 2016. Statistical approaches are
      used to analyze survival outcomes. It is a longitudinal study of a population-based cohort of
      all registered cases of a first episode of stroke that occurred in Catalonia (Spain).
      Demographic Patterns and Epidemic Characteristics. Life expectancy at birth is 81.34 years
      globally, 78.26 years for men and 84.74 years for women.

      Case Definition The definition of stroke corresponds to that set by the World Health
      Organization.

      Patients were included by using the automated operation of the database of patients with a
      diagnosis code of stroke (I60-I69).

      The inclusion criteria were: age ≥ 15 up to ≤ 90; a diagnosis of stroke explicitly recorded
      in their medical record at any of the registration systems in the health centers; it should
      be a first stroke episode, and relevant episode information should be available in clinical
      records: (a) outpatient clinic, (b) hospital clinic, or (c) access to medical/sociosanitary
      reports.

      The variables on which information was collected were grouped as follows: sociodemographic;
      clinics: type (ischemic or hemorrhagic stroke) and event date (day/month/year); NIHSS score
      on admission; whether or not there was thrombolytic therapy; duration of hospital stay;
      hospital discharge destination (home, higher-level acute hospital, long-term care hospital,
      death and date thereof); pre- and poststroke functional autonomy [the Barthel score was
      classified as follows: <20 (total dependence), 20-35 (severe dependence), 40-55 (moderate
      dependence), ≥ 60 (mild dependence), or 100 (independence) registered for preepisode and for
      discharge in the medical history of the patient, the hospital, or the primary care center];
      functional status of the patient at discharge: death, home-autonomous, home address
      caregiver, referral to another acute hospital, or convalescent center (temporary or long-term
      stay), and vital status (alive/dead) of the patient, specifying the date (day/month/year) of
      death, if any.

      Statistical Analysis Computerized statistical analysis was undertaken with the following: (1)
      descriptive basic statistics and standard deviation of key variables stratified by age and
      sex and (2) differences in functional outcome and its evolution before and after the episode
      determined the possible effects on mortality and different residual deficits categorized with
      the statistical Cox regression model. Mortality should be interpreted as overall mortality
      and cause-specific, no stroke. Patients who died during hospitalization or within the 1st
      month are considered 'immediate death'. During follow-up the deceased are described as
      'subsequent mortality'.
observational model: Cohort
time perspective: Cross-Sectional
measure: Death all causes
time frame: January 1, 2011 to December 31, 2016
description: Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.
intervention type: Drug
intervention name: IV thrombolytic (t-PA) treatment vs not
description: Acute Stroke Protocol
other name: IV thrombolysis
other name: IV thrombolytic (t-PA) treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Spain
citation: Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, Gonzalez-Henares MA, Panisello-Tafalla A, Lopez-Pablo C, Lucas-Noll J; Ebrictus Group. Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study. Cerebrovasc Dis Extra. 2015 Oct 9;5(3):95-102. doi: 10.1159/000440734. eCollection 2015 Sep-Dec.
PMID: 26648964
citation: Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, Gonzalez-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten Primaria. 2015 Feb;47(2):108-16. doi: 10.1016/j.aprim.2014.04.008. Epub 2014 Jun 19. Spanish.
PMID: 24953174
citation: Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.
PMID: 27113062
citation: Clua-Espuny JL, Abilleira S, Queralt-Tomas L, Gonzalez-Henares A, Gil-Guillen V, Muria-Subirats E, Ballesta-Ors J. Long-Term Survival After Stroke According to Reperfusion Therapy, Cardiovascular Therapy and Gender. Cardiol Res. 2019 Apr;10(2):89-97. doi: 10.14740/cr839. Epub 2019 Apr 11.
PMID: 31019638
citation: Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen FV, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J. [The stroke care system in Terres de l'Ebre, Spain, after the implementation of the Stroke Code model: Ebrictus Study]. Med Clin (Barc). 2012 May 19;138(14):609-11. doi: 10.1016/j.medcli.2011.10.004. Epub 2011 Dec 6. Spanish.
PMID: 22153783
responsible party type: Principal Investigator
investigator affiliation: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
investigator full name: Josep Lluís Clua Espuny
investigator title: PhD Family and Community Medicine
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Long Term Adverse Effects
mesh term: Fibrinolytic Agents
sharing ipd: No
ipd description: Dates files