xml: <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/NCT06019741</url>
    </required_header>
    <id_info>
      <org_study_id>IR.SUMS.MED.REC.1401.411</org_study_id>
      <nct_id>NCT06019741</nct_id>
    </id_info>
    <brief_title>Rivaroxaban Post Coronary Bypass Surgery</brief_title>
    <official_title>Rivaroxaban and Aspirin Versus Aspirin Alone in Preventing Atherothrombotic Events in Patients Following Coronary Artery Bypass Graft Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shiraz University of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shiraz University of Medical Sciences</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>
        Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low&#xD;
        dose rivaroxaban&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the&#xD;
        effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All&#xD;
        patients referred for either off-pump or on-pump coronary bypass surgery to 3 academic&#xD;
        hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these&#xD;
        sites were informed of this study and asked to refer patients after coronary bypass surgery.&#xD;
  &#xD;
        A total of 414 patients were initially included in the study, but 171 of them were excluded&#xD;
        based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly&#xD;
        divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2,&#xD;
        receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.&#xD;
  &#xD;
        Clinical outcomes were assessed at the end of first year post-operation. Subjects will&#xD;
        undergo a complete history and physical examination and the study variables were assessed.&#xD;
        Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance&#xD;
        was assessed, standard medication was adjusted as appropriate, and all interventions, outcome&#xD;
        events, and adverse events were recorded. The patients were followed for the occurrence of&#xD;
        major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial&#xD;
        infarction (hospital visit for myocardial infarction reported by patient or hospital&#xD;
        admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular&#xD;
        accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise&#xD;
        (assessed with exercise tolerance test) were also evaluated. Additional variables that will&#xD;
        be collected at baseline include demographic and clinical characteristics of patients as&#xD;
        follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus&#xD;
        (yes/no).&#xD;
  &#xD;
        To document any unfavorable occurrences, the patients were questioned via telephone monthly&#xD;
        about any potential side effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2021</start_date>
    <completion_date type="Actual">July 20, 2022</completion_date>
    <primary_completion_date type="Actual">May 1, 2022</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>randomized double blind of placebo and intervention group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>simple randomization</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>MACE</measure>
      <time_frame>1 year</time_frame>
      <description>Major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist) ,and 3) cerebrovascular accidents</description>
    </primary_outcome>
    <primary_outcome>
      <measure>bleeding</measure>
      <time_frame>1 year</time_frame>
      <description>all types of reported bleeding, major or minor</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>functional capacity</measure>
      <time_frame>1 year</time_frame>
      <description>functional capacity assessed by exercise tolerance test, based on METS, duration of toleration of exercise</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">234</enrollment>
    <condition>Post Coronary Bypass Surgery Patients</condition>
    <arm_group>
      <arm_group_label>aspirin and rivaroxaban</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>aspirin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>post coronary bypass patients, received aspirin 80 mg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rivaroxaban and aspirin 80</intervention_name>
      <description>rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery</description>
      <arm_group_label>aspirin and rivaroxaban</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aspirin 80</intervention_name>
      <description>aspirin 80 mg orally post coronary bypass surgery</description>
      <arm_group_label>aspirin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 undergoing primary isolated coronary bypass surgery, with or&#xD;
               without cardiopulmonary bypass&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other cardiac surgeries except for coronary bypass surgery&#xD;
  &#xD;
            -  Left ventricular ejection fraction &lt; 30 %&#xD;
  &#xD;
            -  Liver disease&#xD;
  &#xD;
            -  Clopidogrel or aspirin intake within 7 days of operation&#xD;
  &#xD;
            -  Need for perioperative warfarin&#xD;
  &#xD;
            -  Active gastroduodenal ulcer or post-operative gastrointestinal bleeding&#xD;
  &#xD;
            -  Profuse post-operative pleural effusion (drainage &gt;200 ml/h for 2 h or more&#xD;
  &#xD;
            -  Postoperative low cardiac output syndrome or requirement for high levels of&#xD;
               hemodynamic support (more than 2 inotropes for more than 24 h and/or intra-aortic&#xD;
               balloon pump)&#xD;
  &#xD;
            -  Clinical instability, such as perioperative myocardial infarction or malignant tumor.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>87 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Professor Kojuri Cardiology Clinic</name>
        <address>
          <city>Shiraz</city>
          <state>Fars</state>
          <zip>55318</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Javad Kojuri</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <keyword>coronary bypass surgery</keyword>
    <keyword>aspirin</keyword>
    <keyword>rivaroxaban</keyword>
    <keyword>MACE</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
      <mesh_term>Rivaroxaban</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data is available in professor kojuri registry, and will be available upon rational request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019741
  org study id: IR.SUMS.MED.REC.1401.411
  nct id: NCT06019741
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low
        dose rivaroxaban
  This study is a 1-year randomized, double-blind placebo-controlled trial to evaluate the
        effects of adding rivaroxaban to the treatment of patients after coronary bypass surgery. All
        patients referred for either off-pump or on-pump coronary bypass surgery to 3 academic
        hospitals in Shiraz, Iran were screened according to inclusion criteria. Clinicians at these
        sites were informed of this study and asked to refer patients after coronary bypass surgery.
  
        A total of 414 patients were initially included in the study, but 171 of them were excluded
        based on the exclusion criteria (Figure 1). The remaining 243 patients were then randomly
        divided into two groups: group 1, receiving aspirin 80 mg daily plus placebo; group 2,
        receiving aspirin 80 mg daily plus rivaroxaban 2.5 mg twice daily.
  
        Clinical outcomes were assessed at the end of first year post-operation. Subjects will
        undergo a complete history and physical examination and the study variables were assessed.
        Patients were followed every 2 weeks for any occurrence at these visits, patients' compliance
        was assessed, standard medication was adjusted as appropriate, and all interventions, outcome
        events, and adverse events were recorded. The patients were followed for the occurrence of
        major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial
        infarction (hospital visit for myocardial infarction reported by patient or hospital
        admission for myocardial infarction reported by cardiologist); and 3) cerebrovascular
        accidents. Occurrence of major bleeding and chest pain, and functional capacity exercise
        (assessed with exercise tolerance test) were also evaluated. Additional variables that will
        be collected at baseline include demographic and clinical characteristics of patients as
        follows: sex (male, female), age (mean (SD)), hypertension (yes/no), and diabetes mellitus
        (yes/no).
  
        To document any unfavorable occurrences, the patients were questioned via telephone monthly
        about any potential side effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized double blind of placebo and intervention group
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: simple randomization
  measure: MACE
  time frame: 1 year
  description: Major adverse cardiac events (MACE), defined as follows: 1) cardiogenic death; 2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by cardiologist) ,and 3) cerebrovascular accidents
  measure: bleeding
  time frame: 1 year
  description: all types of reported bleeding, major or minor
  measure: functional capacity
  time frame: 1 year
  description: functional capacity assessed by exercise tolerance test, based on METS, duration of toleration of exercise
  arm group label: aspirin and rivaroxaban
  arm group type: Experimental
  description: post coronary bypass patients, received aspirin 80 mg and rivaroxaban 2.5 mg PO twice daily
  arm group label: aspirin
  arm group type: Active Comparator
  description: post coronary bypass patients, received aspirin 80 mg
  intervention type: Drug
  intervention name: Rivaroxaban and aspirin 80
  description: rivaroxaban 2.5 mg twice daily orally added to aspirin 80 mg post coronary bypass surgery
  arm group label: aspirin and rivaroxaban
  intervention type: Drug
  intervention name: Aspirin 80
  description: aspirin 80 mg orally post coronary bypass surgery
  arm group label: aspirin
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 87 Years
  healthy volunteers: No
  facility: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Shiraz University of Medical Sciences
  investigator full name: Javad Kojuri
  investigator title: professor
  mesh term: Aspirin
  mesh term: Rivaroxaban
  sharing ipd: No
  ipd description: Data is available in professor kojuri registry, and will be available upon rational request