<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/NCT04456842</url>
  </required_header>
  <id_info>
    <org_study_id>001/2018</org_study_id>
    <nct_id>NCT04456842</nct_id>
  </id_info>
  <brief_title>Cardiovascular Registry of Atrial Fibrillation</brief_title>
  <acronym>LACROSS</acronym>
  <official_title>Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brazilian Clinical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brazilian Clinical Research Institute</source>
  <oversight_info>
    <has_dmc>No</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>
      Follow a representative sample of Latin American patients diagnosed with atrial fibrillation&#xD;
      to set data on demographic characteristics, documenting antithrombotic therapy, describe the&#xD;
      INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke,&#xD;
      hemorrhage and death&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be followed 6 months and 1 year after the baseline visit and will be collected&#xD;
      data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic&#xD;
      therapy and clinical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>12 Months</target_duration>
  <primary_outcome>
    <measure>INR control rate</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral anticoagulation discontinuation rate</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of death</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of stroke</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of systemic embolism</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of myocardial infarction</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of major bleeding</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of electrical cardioversion</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of percutaneous ablation of AF</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of atrioventricular junction ablation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients that need of pacemaker implantation</measure>
    <time_frame>12 monts</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of other cardiovascular hospitalization</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Registry Data</intervention_name>
    <description>To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with Atrial Fibrilation or Atrial Flutter&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years-old that signed informed consent;&#xD;
&#xD;
          -  Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source&#xD;
             document;&#xD;
&#xD;
          -  If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should&#xD;
             have 2 electrographic records, at least 15 days apart between them, with one of them&#xD;
             being performed within the last 6 months before enrollment (AF may be documented by&#xD;
             12-lead ECG, Holter monitor-24h);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who did not agree to participate.&#xD;
&#xD;
          -  Patients without possibility of monitoring for one year.&#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>Renato D. Lopes, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Renato D. Lopes, MD, PhD</last_name>
    <phone>55 11 5904 7339</phone>
    <email>renato.lopes@duke.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Interzonal General de Agudos &quot;Dr. José Penna&quot;</name>
      <address>
        <city>Bahía Blanca</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadia Budassi, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>DIM Clínica Privada</name>
      <address>
        <city>Ramos Mejía</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oscar Romano Montaña, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Medicas Temperley (CIMeT)</name>
      <address>
        <city>Temperley</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matias Nicolas Lugo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de La Plata</name>
      <address>
        <city>Buenos Aires</city>
        <state>La Plata</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Cartasegna, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Modelo de Cardiologia</name>
      <address>
        <city>San Miguel De Tucumán</city>
        <state>Tucumán</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Antonio Muntaner, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Medico Luquez</name>
      <address>
        <city>Córdoba</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hugo Armando Luquez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prevención Cardiovascular Salta</name>
      <address>
        <city>Salta</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlos Cuneo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Servicios Médicos El Castaño</name>
      <address>
        <city>San Juan</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moira Alvarez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Cardiovascular San Luis</name>
      <address>
        <city>San Luis</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Albisu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Clinicas del Litoral SRL</name>
      <address>
        <city>Santa Fe</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miguel Hominal, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial Dr. José Maria Cullen</name>
      <address>
        <city>Santa Fe</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristian Edgardo Botta, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Alvorada Taguatinga Ltda</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pedro Gabriel Melo de Barros e Silva, MD, PhD</last_name>
      <email>drpedrobarros80@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sociedad de Cirugia de Bogota - Hospital de San Jose</name>
      <address>
        <city>Bogotá</city>
        <state>Cundinamarca</state>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alejandro Olaya Sánchez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Valle del Lili</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Fernando Pava, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Francisco Gerardo Padilla Padilla</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francisco Gerardo Padilla Padilla, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)</name>
      <address>
        <city>Querétaro City</city>
        <state>Querétaro</state>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Antonio Alcocer Gamba, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.</name>
      <address>
        <city>Culiacán</city>
        <state>Sinaloa</state>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Odin de Los Rios Ibarra, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Colombia</country>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrilation</keyword>
  <keyword>Antithrombotic therapy</keyword>
  <keyword>Atrial Flutter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04456842
org study id: 001/2018
nct id: NCT04456842
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Follow a representative sample of Latin American patients diagnosed with atrial fibrillation
      to set data on demographic characteristics, documenting antithrombotic therapy, describe the
      INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke,
      hemorrhage and death
Patients will be followed 6 months and 1 year after the baseline visit and will be collected
      data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic
      therapy and clinical outcomes.
observational model: Cohort
time perspective: Prospective
measure: INR control rate
time frame: 12 months
measure: Oral anticoagulation discontinuation rate
time frame: 12 months
measure: Percentage of death
time frame: 12 months
measure: Percentage of stroke
time frame: 12 months
measure: Percentage of systemic embolism
time frame: 12 months
measure: Percentage of myocardial infarction
time frame: 12 months
measure: Percentage of major bleeding
time frame: 12 months
measure: Percentage of electrical cardioversion
time frame: 12 months
measure: Percentage of percutaneous ablation of AF
time frame: 12 months
measure: Percentage of atrioventricular junction ablation
time frame: 12 months
measure: Percentage of patients that need of pacemaker implantation
time frame: 12 monts
measure: Percentage of other cardiovascular hospitalization
time frame: 12 months
intervention type: Other
intervention name: Patient Registry Data
description: To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renato D. Lopes, MD, PhD
role: Study Chair
affiliation: Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI
last name: Renato D. Lopes, MD, PhD
phone: 55 11 5904 7339
email: renato.lopes@duke.edu
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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country: Argentina
country: Brazil
country: Colombia
country: Mexico
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Atrial Flutter
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)