<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/NCT02238470</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-ACO-2010-10</org_study_id>
    <secondary_id>PI11/00296</secondary_id>
    <nct_id>NCT02238470</nct_id>
  </id_info>
  <brief_title>Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance</brief_title>
  <acronym>HERO</acronym>
  <official_title>Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the&#xD;
      risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite&#xD;
      oral anticoagulation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES. To evaluate whether Magnetic Resonance (MR) helps in predicting the risk of&#xD;
      Intracranial Hemorrhage (ICH-OA) in patients with ischemic stroke who will receive Oral&#xD;
      Anticoagulants (OA) for the secondary prevention of stroke. By allowing the detection and&#xD;
      quantification of leukoaraiosis and microbleeding, MR aids in the assessment of hypertensive&#xD;
      and/or amyloid angiopathy, two findings that may increase the risk of ICH-OA. The study of&#xD;
      these and other known variables associated with the risk of ICH-OA will improve the selection&#xD;
      of patients to be treated with OA. METHODOLOGY. A prospective, observational, multicentric&#xD;
      study of 1000 patients with stroke, older than 65 y, candidates to receive OA indefinitely.&#xD;
      The primary end-point is ICH-OA. A MR will be performed before starting the treatment, in&#xD;
      which we will evaluate the presence and degree of leukoaraiosis (Fazekas's scale) and&#xD;
      microbleeding (BOMBS scale). A visit will be scheduled at the first month after inclusion,&#xD;
      and thereafter the patient will be followed-up during 2 years with phone interviews, to&#xD;
      evaluate the appearance of the primary end-point. We will register data about demographics,&#xD;
      vascular risk factors, anticoagulation, MR, echocardiography and co-morbidity. With those&#xD;
      variables associated with ICH-OA in the univariate analyses, a regression analysis will be&#xD;
      performed, in which ICH-OA will be the dependent variable. Finally, each independent&#xD;
      predictive variable will receive a score to elaborate a predictive model of ICH-OA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Intracranial Hemorrhage</measure>
    <time_frame>every 3 months after stroke, until 24 months</time_frame>
    <description>Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ischemic stroke</measure>
    <time_frame>within 24 months after inclusion</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Oral anticoagulants</arm_group_label>
    <description>Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral anticoagulants</intervention_name>
    <description>Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging</description>
    <arm_group_label>Oral anticoagulants</arm_group_label>
    <other_name>warfarin</other_name>
    <other_name>coumarin</other_name>
    <other_name>dabigatran</other_name>
    <other_name>rivaroxaban</other_name>
    <other_name>apixaban</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to tertiaty hospital for cardioembolic ischemic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 65 y&#xD;
&#xD;
          2. TIA or ischemic stroke&#xD;
&#xD;
          3. The patient will receive indefinitely treatment with oral anticoagulants for the&#xD;
             secondary prevention of cardioembolic stroke&#xD;
&#xD;
          4. No previous treatment with oral anticoagulants&#xD;
&#xD;
          5. Signed consent before performing a Magnetic Resonance&#xD;
&#xD;
          6. Long-term follow-up will be possible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient will receive oral anticoagulation as a primary prevention treatment&#xD;
&#xD;
          2. The etiology that motivates the onset of oral anticoagulants is not cardioembolism&#xD;
&#xD;
          3. Absolute contraindication to receive oral anticoagulants&#xD;
&#xD;
          4. Arterial hypertension that is not controlled, hypertensive crisis&#xD;
&#xD;
          5. Dementia&#xD;
&#xD;
          6. Live-expectancy less than 1 year&#xD;
&#xD;
          7. Any social or psychological reason that prevents follow-up&#xD;
&#xD;
          8. Contraindication to perform a Magnetic Resonance examination&#xD;
&#xD;
          9. Patients who received oral antiacoagulants prior to the current stroke&#xD;
&#xD;
         10. The Magnetic Resonance imaging was performed more than 1 month after the onset of&#xD;
             treatment with oral anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan Martí-Fàbregas, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biomedical Research Institute Sant Pau (IIB Sant Pau)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arcispedale Santa Maria Nuova IRCCS</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundació Hospital Asil Granollers</name>
      <address>
        <city>Granollers</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Mataró</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Moisés Broggi</name>
      <address>
        <city>Sant Joan Despí</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mutua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Cinta</name>
      <address>
        <city>Tortosa</city>
        <state>Tarragona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Albacete</name>
      <address>
        <city>Albacete</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CA de Burgos</name>
      <address>
        <city>Burgos</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcántara</name>
      <address>
        <city>Cáceres</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donostia</name>
      <address>
        <city>Donostia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de las Nieves</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de León</name>
      <address>
        <city>León</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Lleida</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Rioja</name>
      <address>
        <city>Logroño</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Asturias</name>
      <address>
        <city>Oviedo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CU de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ischemic stroke</keyword>
  <keyword>Intracerebral hemorrhage</keyword>
  <keyword>Subdural hemorrhage</keyword>
  <keyword>Microbleed</keyword>
  <keyword>Leukoaraiosis</keyword>
  <keyword>Oral anticoagulants</keyword>
  <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 Hemorrhage</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
    <mesh_term>Apixaban</mesh_term>
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238470
org study id: IIBSP-ACO-2010-10
secondary id: PI11/00296
nct id: NCT02238470
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the
      risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite
      oral anticoagulation
OBJECTIVES. To evaluate whether Magnetic Resonance (MR) helps in predicting the risk of
      Intracranial Hemorrhage (ICH-OA) in patients with ischemic stroke who will receive Oral
      Anticoagulants (OA) for the secondary prevention of stroke. By allowing the detection and
      quantification of leukoaraiosis and microbleeding, MR aids in the assessment of hypertensive
      and/or amyloid angiopathy, two findings that may increase the risk of ICH-OA. The study of
      these and other known variables associated with the risk of ICH-OA will improve the selection
      of patients to be treated with OA. METHODOLOGY. A prospective, observational, multicentric
      study of 1000 patients with stroke, older than 65 y, candidates to receive OA indefinitely.
      The primary end-point is ICH-OA. A MR will be performed before starting the treatment, in
      which we will evaluate the presence and degree of leukoaraiosis (Fazekas's scale) and
      microbleeding (BOMBS scale). A visit will be scheduled at the first month after inclusion,
      and thereafter the patient will be followed-up during 2 years with phone interviews, to
      evaluate the appearance of the primary end-point. We will register data about demographics,
      vascular risk factors, anticoagulation, MR, echocardiography and co-morbidity. With those
      variables associated with ICH-OA in the univariate analyses, a regression analysis will be
      performed, in which ICH-OA will be the dependent variable. Finally, each independent
      predictive variable will receive a score to elaborate a predictive model of ICH-OA.
observational model: Cohort
time perspective: Prospective
measure: Intracranial Hemorrhage
time frame: every 3 months after stroke, until 24 months
description: Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months)
measure: Ischemic stroke
time frame: within 24 months after inclusion
arm group label: Oral anticoagulants
description: Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke
intervention type: Drug
intervention name: oral anticoagulants
description: Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging
arm group label: Oral anticoagulants
other name: warfarin
other name: coumarin
other name: dabigatran
other name: rivaroxaban
other name: apixaban
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Joan Martí-Fàbregas, MD,PhD
role: Principal Investigator
affiliation: Biomedical Research Institute Sant Pau (IIB Sant Pau)
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country: Italy
country: Spain
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Hemorrhage
mesh term: Ischemia
mesh term: Hemorrhage
mesh term: Warfarin
mesh term: Rivaroxaban
mesh term: Dabigatran
mesh term: Apixaban
mesh term: Anticoagulants