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/NCT06020300</url>
    </required_header>
    <id_info>
      <org_study_id>FF-2023-191</org_study_id>
      <nct_id>NCT06020300</nct_id>
    </id_info>
    <brief_title>Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)</brief_title>
    <official_title>Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National University of Malaysia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National University of Malaysia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction&#xD;
        (STEMI)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to&#xD;
        reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial&#xD;
        infarction which may benefit in short and long term outcome in patients. The short term&#xD;
        outcome is measured using serum troponin and long term outcome is assessed with transthoracic&#xD;
        echocardiogram and major adverse cardiac events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 29, 2023</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>Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine &amp; placebo group with 1:1 ratio</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Tablet Pyridoxine used as placebo in view of tablet colchicine look alike</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Anti-Inflammatory Effect of Colchicine</measure>
      <time_frame>3-7 days</time_frame>
      <description>Serum Troponin I change from arrival to discharge</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Major Adverse Cardiac Events (MACE)</measure>
      <time_frame>3 months</time_frame>
      <description>Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Trans thoracic Echo cardiogram parameters</measure>
      <time_frame>3 months</time_frame>
      <description>Left ventricular ejection fraction (biplane mode) measured in %, left ventricular volume measured in milliliters, left atrial volume measured in milliliters, E/A ratio, E/e ' ratio</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of colchicine</measure>
      <time_frame>1 month</time_frame>
      <description>Number of Participants with medication side effects</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>STEMI</condition>
    <arm_group>
      <arm_group_label>Colchicine Post ST Elevation Myocardial Infarction (STEMI)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral Colchicine 0.6 mg</intervention_name>
      <description>Anti-Inflammatory Effects</description>
      <arm_group_label>Colchicine Post ST Elevation Myocardial Infarction (STEMI)</arm_group_label>
      <other_name>GOUTNOR 0.6 mg Tablet</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral Pyridoxine 10 mg</intervention_name>
      <description>Colchicine look alike placebo</description>
      <arm_group_label>Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)</arm_group_label>
      <other_name>MSA Pyridoxine HCI 10 mg Tablet</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18 years to 80 years old&#xD;
  &#xD;
            2. STEMI within 24 hours of admission to Pusat Perubatan UKM &amp; undergoing&#xD;
               revascularization therapy (percutaneous coronary intervention) during admission&#xD;
  &#xD;
          STEMI is diagnosed when there is:&#xD;
  &#xD;
            -  ST elevation of ≥1 mm in 2 contiguous leads or&#xD;
  &#xD;
            -  a new onset LBBB in the resting ECG&#xD;
  &#xD;
            -  in a patient with ischaemic type chest pains of &gt; 30 minutes and&#xD;
  &#xD;
            -  accompanied by a rise and fall in cardiac biomarkers (CPG MALAYSIA STEMI 2019, 4th&#xD;
               Edition)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pre-existing severe heart failure with left ventricular ejection fraction less than&#xD;
               35%&#xD;
  &#xD;
            2. Clinically unstable (Intubated or double inotropic support)&#xD;
  &#xD;
            3. Refuse or not suitable for cardiac revascularization therapy&#xD;
  &#xD;
            4. Anaemia induced Angina (Hb &lt; 9 g/dL)&#xD;
  &#xD;
            5. Ongoing sepsis requiring antibiotic&#xD;
  &#xD;
            6. Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol&#xD;
               chart type 6 &amp; 7)&#xD;
  &#xD;
            7. Active Covid-19 Infection (&lt; 7 days for Category 1-3, &lt; 10 days for category 4-5)&#xD;
  &#xD;
            8. Stroke within previous 3 months&#xD;
  &#xD;
            9. Coronary bypass surgery either within the previous 3 years or planned&#xD;
  &#xD;
           10. Active malignancy or treated malignancy within 7 years&#xD;
  &#xD;
           11. Active Inflammatory bowel disease on treatment&#xD;
  &#xD;
           12. Active Neuromuscular disease on treatment&#xD;
  &#xD;
           13. Chronic kidney disease (CKD stage 4 - eGFR &lt; 30 mL/min/1.73 m2)&#xD;
  &#xD;
           14. Severe hepatic disease (ALT &gt; 3X upper limit normal, Bilirubin &gt; 2X upper limit&#xD;
               normal)&#xD;
  &#xD;
           15. Active drug or alcohol abuse on therapy&#xD;
  &#xD;
           16. On long term or recent systemic glucocorticoid therapy within 3 months&#xD;
  &#xD;
           17. Pregnancy or breastfeeding&#xD;
  &#xD;
           18. Known sensitivity to colchicine or multivitamin tablet&#xD;
  &#xD;
           19. Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever,&#xD;
               etc)&#xD;
  &#xD;
           20. Patients on oral medications that may interact with colchicine (Clarithromycin,&#xD;
               Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>HAMAT HAMDI, MBBchBAO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Head of Cardiology Unit</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>CHITHAMBARAM SETHURAMAN, MBBS</last_name>
      <phone>03-9145</phone>
      <phone_ext>8251</phone_ext>
      <email>chithambaramsethuraman@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>HAMAT HAMDI, MBBchBAO</last_name>
      <phone>03-9145</phone>
      <phone_ext>8251</phone_ext>
      <email>hamathamdi@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nationa University of Malaysia</name>
        <address>
          <city>Kuala Lumpur</city>
          <state>Wilayah Persekutuan</state>
          <zip>56000</zip>
          <country>Malaysia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>CHITHAMBARAM SETHURAMAN, MBBS</last_name>
        <phone>03-9145</phone>
        <phone_ext>8251</phone_ext>
        <email>chithambaramsethuraman@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>HAMAT HAMDI, MBBchBAO</last_name>
        <phone>03-9145</phone>
        <phone_ext>8251</phone_ext>
        <email>hamathamdi@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pyridoxine</mesh_term>
      <mesh_term>Pyridoxal</mesh_term>
      <mesh_term>Vitamin B 6</mesh_term>
      <mesh_term>Colchicine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06020300
  org study id: FF-2023-191
  nct id: NCT06020300
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction
        (STEMI)
  Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to
        reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial
        infarction which may benefit in short and long term outcome in patients. The short term
        outcome is measured using serum troponin and long term outcome is assessed with transthoracic
        echocardiogram and major adverse cardiac events.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Block randomization method will be used for sampling. Patients recruited will be randomly assigned to colchicine & placebo group with 1:1 ratio
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Tablet Pyridoxine used as placebo in view of tablet colchicine look alike
  measure: Anti-Inflammatory Effect of Colchicine
  time frame: 3-7 days
  description: Serum Troponin I change from arrival to discharge
  measure: Major Adverse Cardiac Events (MACE)
  time frame: 3 months
  description: Recurrent myocardial infarction, unstable angina needing hospital admission, cardiac death, unplanned repeated revascularization, cerebrovascular accident
  measure: Trans thoracic Echo cardiogram parameters
  time frame: 3 months
  description: Left ventricular ejection fraction (biplane mode) measured in %, left ventricular volume measured in milliliters, left atrial volume measured in milliliters, E/A ratio, E/e ' ratio
  measure: Safety of colchicine
  time frame: 1 month
  description: Number of Participants with medication side effects
  arm group label: Colchicine Post ST Elevation Myocardial Infarction (STEMI)
  arm group type: Experimental
  description: 32 patients with STEMI are assigned for oral colchicine 0.6 mg once daily upon admission for 30 days
  arm group label: Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)
  arm group type: Placebo Comparator
  description: Another 32 patients with STEMI are assigned for placebo (oral pyridoxine 10 mg) once daily upon admission for 30 days
  intervention type: Drug
  intervention name: Oral Colchicine 0.6 mg
  description: Anti-Inflammatory Effects
  arm group label: Colchicine Post ST Elevation Myocardial Infarction (STEMI)
  other name: GOUTNOR 0.6 mg Tablet
  intervention type: Drug
  intervention name: Oral Pyridoxine 10 mg
  description: Colchicine look alike placebo
  arm group label: Placebo (Pyridoxine) Post ST Elevation myocardial Infraction (STEMI)
  other name: MSA Pyridoxine HCI 10 mg Tablet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: HAMAT HAMDI, MBBchBAO
  role: Principal Investigator
  affiliation: Head of Cardiology Unit
  last name: CHITHAMBARAM SETHURAMAN, MBBS
  phone: 03-9145
  phone ext: 8251
  email: chithambaramsethuraman@gmail.com
  last name: HAMAT HAMDI, MBBchBAO
  phone: 03-9145
  phone ext: 8251
  email: hamathamdi@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Malaysia
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: ST Elevation Myocardial Infarction
  mesh term: Infarction
  mesh term: Pyridoxine
  mesh term: Pyridoxal
  mesh term: Vitamin B 6
  mesh term: Colchicine
  sharing ipd: No