<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/NCT03021343</url>
  </required_header>
  <id_info>
    <org_study_id>KMC-JCC</org_study_id>
    <nct_id>NCT03021343</nct_id>
  </id_info>
  <brief_title>Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients</brief_title>
  <acronym>END-AF</acronym>
  <official_title>Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan Collaborating Cardiology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jordan Collaborating Cardiology Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the role of colchicine in the prevention of atrial fibrillation in&#xD;
      patients undergoing open heart surgery. Half of participants will receive colchicine and the&#xD;
      other half will not&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery&#xD;
      and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase&#xD;
      morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to&#xD;
      increased hospital stay with its associated higher health care cost.&#xD;
&#xD;
      Previous studies have demonstrated that increased inflammation may precede AF and, therefore,&#xD;
      interventions that reduce the inflammatory process may help reduce the incidence of AF.&#xD;
      Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing&#xD;
      the incidence of AF.&#xD;
&#xD;
      This study aims to determine whether the administration of colchicine starting the day before&#xD;
      cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants With Atrial Fibrillation</measure>
    <time_frame>From date of randomization until the date of discharge, assessed up to 2 weeks</time_frame>
    <description>The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants With Colchicine Side Effects</measure>
    <time_frame>From date of randomization until the date of discharge, assessed up to 2 weeks</time_frame>
    <description>The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Colchicine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing &lt;70 kg or intolerant to the full dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No colchicine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm no active medication was administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colchicine</intervention_name>
    <description>colchicine given as per trial protocol</description>
    <arm_group_label>Colchicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive adult patients undergoing elective cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on&#xD;
             hospital admission&#xD;
&#xD;
          -  Known severe liver disease or current transaminases &gt;1.5 times the upper normal limit&#xD;
&#xD;
          -  Current serum creatinine &gt;2.5 mg/dl&#xD;
&#xD;
          -  Known myopathy or elevated baseline preoperative creatine kinase&#xD;
&#xD;
          -  Known blood dyscrasias&#xD;
&#xD;
          -  Significant gastrointestinal disease&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Known hypersensitivity to colchicine&#xD;
&#xD;
          -  Current treatment with colchicine for any indications&#xD;
&#xD;
          -  Emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramzi A Tabbalat, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Khalidi Hospital and Medical Center</affiliation>
  </overall_official>
  <results_reference>
    <citation>Tabbalat RA, Hamad NM, Alhaddad IA, Hammoudeh A, Akasheh BF, Khader Y. Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial. Am Heart J. 2016 Aug;178:102-7. doi: 10.1016/j.ahj.2016.05.006. Epub 2016 May 17.</citation>
    <PMID>27502857</PMID>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 22, 2015</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>November 28, 2017</results_first_submitted>
  <results_first_submitted_qc>November 28, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 26, 2017</results_first_posted>
  <last_update_submitted>December 24, 2017</last_update_submitted>
  <last_update_submitted_qc>December 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Colchicine</keyword>
  <keyword>Cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colchicine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>yes</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>2 years from publication date</ipd_time_frame>
    <ipd_access_criteria>For research purposes after direct contact with principal investigator</ipd_access_criteria>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Colchicine</title>
          <description>Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing &lt;70 kg or intolerant to the full dose.&#xD;
Colchicine: colchicine given as per trial protocol</description>
        </group>
        <group group_id="P2">
          <title>No Colchicine</title>
          <description>In this arm no active medication was administered</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="179"/>
                <participants group_id="P2" count="181"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="174"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Colchicine</title>
          <description>Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing &lt;70 kg or intolerant to the full dose.&#xD;
Colchicine: colchicine given as per trial protocol</description>
        </group>
        <group group_id="B2">
          <title>No Colchicine</title>
          <description>In this arm no active medication was administered</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="179"/>
            <count group_id="B2" value="181"/>
            <count group_id="B3" value="360"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="179"/>
                    <count group_id="B2" value="181"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.8" lower_limit="20" upper_limit="82"/>
                    <measurement group_id="B2" value="60.5" lower_limit="23" upper_limit="98"/>
                    <measurement group_id="B3" value="60.6" lower_limit="20" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="179"/>
                    <count group_id="B2" value="181"/>
                    <count group_id="B3" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants With Atrial Fibrillation</title>
        <description>The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant</description>
        <time_frame>From date of randomization until the date of discharge, assessed up to 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing &lt;70 kg or intolerant to the full dose.&#xD;
Colchicine: colchicine given as per trial protocol</description>
          </group>
          <group group_id="O2">
            <title>No Colchicine</title>
            <description>In this arm no active medication was administered</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Atrial Fibrillation</title>
          <description>The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants With Colchicine Side Effects</title>
        <description>The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.</description>
        <time_frame>From date of randomization until the date of discharge, assessed up to 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Colchicine</title>
            <description>Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing &lt;70 kg or intolerant to the full dose.&#xD;
Colchicine: colchicine given as per trial protocol</description>
          </group>
          <group group_id="O2">
            <title>No Colchicine</title>
            <description>In this arm no active medication was administered</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Colchicine Side Effects</title>
          <description>The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Colchicine</title>
          <description>Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing &lt;70 kg or intolerant to the full dose.&#xD;
Colchicine: colchicine given as per trial protocol</description>
        </group>
        <group group_id="E2">
          <title>No Colchicine</title>
          <description>In this arm no active medication was administered</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="44" subjects_affected="44" subjects_at_risk="179"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ramzi Tabbalat</name_or_title>
      <organization>Khalidi Hospital &amp; Medical Center</organization>
      <phone>00962795535522</phone>
      <email>ramzi_md@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03021343
org study id: KMC-JCC
nct id: NCT03021343
lead sponsor: 
has dmc: Yes
This study evaluates the role of colchicine in the prevention of atrial fibrillation in
      patients undergoing open heart surgery. Half of participants will receive colchicine and the
      other half will not
Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery
      and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase
      morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to
      increased hospital stay with its associated higher health care cost.

      Previous studies have demonstrated that increased inflammation may precede AF and, therefore,
      interventions that reduce the inflammatory process may help reduce the incidence of AF.
      Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing
      the incidence of AF.

      This study aims to determine whether the administration of colchicine starting the day before
      cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The Number of Participants With Atrial Fibrillation
time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
description: The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
measure: The Number of Participants With Colchicine Side Effects
time frame: From date of randomization until the date of discharge, assessed up to 2 weeks
description: The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.
arm group label: Colchicine
arm group type: Active Comparator
description: Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.
arm group label: No colchicine
arm group type: No Intervention
description: In this arm no active medication was administered
intervention type: Drug
intervention name: Colchicine
description: colchicine given as per trial protocol
arm group label: Colchicine
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ramzi A Tabbalat, MD, FACC
role: Principal Investigator
affiliation: Khalidi Hospital and Medical Center
citation: Tabbalat RA, Hamad NM, Alhaddad IA, Hammoudeh A, Akasheh BF, Khader Y. Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial. Am Heart J. 2016 Aug;178:102-7. doi: 10.1016/j.ahj.2016.05.006. Epub 2016 May 17.
PMID: 27502857
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Colchicine
sharing ipd: Yes
ipd description: yes
ipd info type: Study Protocol
ipd time frame: 2 years from publication date
ipd access criteria: For research purposes after direct contact with principal investigator
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 