<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/NCT03015831</url>
  </required_header>
  <id_info>
    <org_study_id>JordanCCG</org_study_id>
    <nct_id>NCT03015831</nct_id>
  </id_info>
  <brief_title>Effect of Low Dose ColchiciNe on the InciDence of POAF</brief_title>
  <acronym>END-AFLD</acronym>
  <official_title>Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the&#xD;
      incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test&#xD;
      0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in&#xD;
      several studies to lower the incidence AF but the results were generally disappointing. There&#xD;
      was no benefit in reducing AF and there was a high incidence of GI side effects especially&#xD;
      diarrhea, often leading to stopping the medication. However, a recently published&#xD;
      meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI&#xD;
      side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is&#xD;
      hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac&#xD;
      surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs.&#xD;
      placebo started the day before surgery and continued until hospital discharge.&#xD;
&#xD;
      The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will&#xD;
      be the GI side effects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Statistical analysis of interim data showed no advantage of colchicine&#xD;
  </why_stopped>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
    <description>AF documented by EKG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects of colchicine</measure>
    <time_frame>Through study completion, an average of 1 week</time_frame>
    <description>Gastrointestinal side effects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Cardiac Surgery</condition>
  <condition>Colchicine Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Colchicine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical tablet (placebo) administered in a similar way as that in the active comparator arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colchicine</intervention_name>
    <description>Colchicine will be given to open heart surgery patients</description>
    <arm_group_label>Colchicine</arm_group_label>
    <other_name>Colcrys, Mitigare</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo Oral Tablet will be given to open heart surgery patients according to randomization</description>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients aged 18 years or above undergoing elective cardiac surgery.&#xD;
&#xD;
          -  Sinus rhythm and no previous AF&#xD;
&#xD;
          -  Agreed to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#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 or 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>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramzi Tabbalat, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istishari Hospital</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jordan Hospital</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khalidi Hospital &amp; Medical Center</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>Colchicine</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>Our Group's website will share data. Researchgate will share data. Eventual results will be announced to medical community through local presentations, and international congresses and publications.</ipd_description>
  </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/NCT03015831
org study id: JordanCCG
nct id: NCT03015831
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the
      incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test
      0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.
AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in
      several studies to lower the incidence AF but the results were generally disappointing. There
      was no benefit in reducing AF and there was a high incidence of GI side effects especially
      diarrhea, often leading to stopping the medication. However, a recently published
      meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI
      side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is
      hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac
      surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs.
      placebo started the day before surgery and continued until hospital discharge.

      The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will
      be the GI side effects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Atrial fibrillation
time frame: Through study completion, an average of 1 week
description: AF documented by EKG
measure: Side effects of colchicine
time frame: Through study completion, an average of 1 week
description: Gastrointestinal side effects
arm group label: Colchicine
arm group type: Active Comparator
description: Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge
arm group label: Placebo Oral Tablet
arm group type: Placebo Comparator
description: Identical tablet (placebo) administered in a similar way as that in the active comparator arm
intervention type: Drug
intervention name: Colchicine
description: Colchicine will be given to open heart surgery patients
arm group label: Colchicine
other name: Colcrys, Mitigare
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo Oral Tablet will be given to open heart surgery patients according to randomization
arm group label: Placebo Oral Tablet
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Ramzi Tabbalat, MD, FACC
role: Principal Investigator
affiliation: JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan
facility: 
facility: 
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Colchicine
sharing ipd: Yes
ipd description: Our Group's website will share data. Researchgate will share data. Eventual results will be announced to medical community through local presentations, and international congresses and publications.