<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/NCT03803579</url>
  </required_header>
  <id_info>
    <org_study_id>FAA O3 12-2017 (MAS)</org_study_id>
    <nct_id>NCT03803579</nct_id>
  </id_info>
  <brief_title>Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)</brief_title>
  <acronym>MAS</acronym>
  <official_title>Baseline DOAC Measurement in Non Valvular Atrial Fibrillation Patients and Incidence of Bleeding or Thromboembolic Complications During Follow-up: a Prospective, Multicenter, Observational Study. The MAS (Measure And See) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arianna Anticoagulazione Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arianna Anticoagulazione Foundation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MAS Study is an observational, multicentre, prospective cohort study in Non valvular&#xD;
      Atrial fibrillation (NVAF) patients treated with one of the direct oral anticoagulants&#xD;
      (DOACs) available in Italy for NVAF patients.&#xD;
&#xD;
      The general aim is to deepen the knowledge of DOAC treatment in NVAF patients, by measuring&#xD;
      the plasma concentration of anticoagulant drugs and their correlation with any adverse events&#xD;
      that may occur during treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MAS Study is an observational, prospective cohort study, double blind, multicentre,&#xD;
      international and no Profit. Anticoagulation clinics, affiliated or not to the Italian FCSA,&#xD;
      will be asked to take an active part in the study, provided they have the facilities for&#xD;
      blood sampling and processing.&#xD;
&#xD;
      4000 consecutive NVAF outpatients, 1000 for each single drug, starting anticoagulation with&#xD;
      one of the four DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) will be enrolled at the&#xD;
      moment of the first prescription. Patients will receive the type and dosage of DOAC on the&#xD;
      base of clinical characteristics at the discretion of the attending physician, as the normal&#xD;
      clinical practice, and the study will not influence the decision of the type and dosage of&#xD;
      DOAC.&#xD;
&#xD;
      The primary study objective is to evaluate the possible relationship between DOAC&#xD;
      anticoagulant levels at the trough, measured at steady state (within the first 2-4 weeks of&#xD;
      treatment) and occurrence of bleeding and thromboembolic events during the subsequent one&#xD;
      year follow up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2018</start_date>
  <completion_date type="Actual">May 30, 2023</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines)</measure>
    <time_frame>From date of enrollment until the date of first documented event assessed up to 12 months</time_frame>
    <description>Fatal bleeding; Acute clinically overt bleeding;intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal will be recorded in all patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and rate of patients with confirmed thromboembolic and thromboembolic-related dath</measure>
    <time_frame>From date of enrollment until the date of first documented event assessed up to 12 months</time_frame>
    <description>Cardiovascular event: transient ischemic attack, stroke. myocardial infarction; the occurrence of deep vein thrombosis with or without pulmonary embolism will be recorded in all patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and rate of death patients (overall mortality)</measure>
    <time_frame>From date of enrollment until the date of first documented event assessed up to 12 months</time_frame>
    <description>Cardiovascular related death; thromboembolic related dath, bleeding-related death, cancer related death will be recorded in all patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban</measure>
    <time_frame>15-20 days after the enrollment</time_frame>
    <description>Blood sampling is performed at trough level for each anticoagulant drug used after the last dose intake of dabigatran, apixaban, rivaroxaban and edoxaban</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and rate of patients who discontinued treatment</measure>
    <time_frame>From date of enrollment until the date of first documented event assessed up to 12 months</time_frame>
    <description>The treatment withdrawal, either for patients or for physician decision-making will be recorded in all patients</description>
  </secondary_outcome>
  <enrollment type="Actual">2000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Anticoagulant-induced Bleeding</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        4000 consecutive Non Valvular Atrial Fibrillation outpatients, 1000 for each single drug,&#xD;
        aged &gt;18 years and starting anticoagulation with one of the four DOAC (apixaban,&#xD;
        dabigatran, edoxaban, rivaroxaban) will be enrolled at the moment of the first&#xD;
        prescription. Patients will receive the type and dosage of DOAC on the base of clinical&#xD;
        characteristics at the discretion of the attending physician, as the normal clinical&#xD;
        practice, and the study will not influence the decision of the type and dosage of DOAC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NVAF patients starting DOAC anticoagulation&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  ability to give written informed consent&#xD;
&#xD;
          -  availability, as part of the normal withdrawals, to the blood sampling for the study&#xD;
             purpose&#xD;
&#xD;
          -  availability for 12-months follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  indication for electrical cardioversion at the moment of drug prescription&#xD;
&#xD;
          -  participation in Phase II or III clinical trials&#xD;
&#xD;
          -  indication for treatment different from NVAF&#xD;
&#xD;
          -  not suitable to give or not giving informed consent&#xD;
&#xD;
          -  not available for blood collection or follow-up&#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>Sophie Testa, MD</last_name>
    <role>Study Director</role>
    <affiliation>UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sophie Testa</name>
      <address>
        <city>Cremona</city>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Bleeding event</keyword>
  <keyword>Thromboembolic event</keyword>
  <keyword>Plasma concentration of drug</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03803579/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03803579
org study id: FAA O3 12-2017 (MAS)
nct id: NCT03803579
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The MAS Study is an observational, multicentre, prospective cohort study in Non valvular
      Atrial fibrillation (NVAF) patients treated with one of the direct oral anticoagulants
      (DOACs) available in Italy for NVAF patients.

      The general aim is to deepen the knowledge of DOAC treatment in NVAF patients, by measuring
      the plasma concentration of anticoagulant drugs and their correlation with any adverse events
      that may occur during treatment.
The MAS Study is an observational, prospective cohort study, double blind, multicentre,
      international and no Profit. Anticoagulation clinics, affiliated or not to the Italian FCSA,
      will be asked to take an active part in the study, provided they have the facilities for
      blood sampling and processing.

      4000 consecutive NVAF outpatients, 1000 for each single drug, starting anticoagulation with
      one of the four DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) will be enrolled at the
      moment of the first prescription. Patients will receive the type and dosage of DOAC on the
      base of clinical characteristics at the discretion of the attending physician, as the normal
      clinical practice, and the study will not influence the decision of the type and dosage of
      DOAC.

      The primary study objective is to evaluate the possible relationship between DOAC
      anticoagulant levels at the trough, measured at steady state (within the first 2-4 weeks of
      treatment) and occurrence of bleeding and thromboembolic events during the subsequent one
      year follow up
observational model: Cohort
time perspective: Prospective
measure: Number and rate of major bleeding events and clinically relevant bleeds (defined according to International Society on Thrombosis and Haemostasis guidelines)
time frame: From date of enrollment until the date of first documented event assessed up to 12 months
description: Fatal bleeding; Acute clinically overt bleeding;intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal will be recorded in all patients.
measure: Number and rate of patients with confirmed thromboembolic and thromboembolic-related dath
time frame: From date of enrollment until the date of first documented event assessed up to 12 months
description: Cardiovascular event: transient ischemic attack, stroke. myocardial infarction; the occurrence of deep vein thrombosis with or without pulmonary embolism will be recorded in all patients.
measure: Number and rate of death patients (overall mortality)
time frame: From date of enrollment until the date of first documented event assessed up to 12 months
description: Cardiovascular related death; thromboembolic related dath, bleeding-related death, cancer related death will be recorded in all patients
measure: Through plasma concentration (ng/ml) of Apixaban, Dabigatran, Edoxaban and Rivaroxaban
time frame: 15-20 days after the enrollment
description: Blood sampling is performed at trough level for each anticoagulant drug used after the last dose intake of dabigatran, apixaban, rivaroxaban and edoxaban
measure: Number and rate of patients who discontinued treatment
time frame: From date of enrollment until the date of first documented event assessed up to 12 months
description: The treatment withdrawal, either for patients or for physician decision-making will be recorded in all patients
plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Testa, MD
role: Study Director
affiliation: UUOO Lab Analisi Chim Cliniche Microb-Centro Emostasi, ASST-Cremona Italy
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Hemorrhage
provided document: 