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/NCT06025071</url>
    </required_header>
    <id_info>
      <org_study_id>2023-GSP-GG-40</org_study_id>
      <nct_id>NCT06025071</nct_id>
    </id_info>
    <brief_title>Residual Inflammatory Risk-Guided colcHicine in Elderly Trial</brief_title>
    <acronym>RIGHT</acronym>
    <official_title>Efficacy and Safety of Residual Inflammatory Risk-Guided Low-dose Colchicine Therapy in Elderly Patients With Multivessel Coronary Artery Disease: A Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese Academy of Medical Sciences, Fuwai Hospital</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 goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no&#xD;
        specific intervention in selected elderly patients (60-80 years old) with residual&#xD;
        inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions&#xD;
        it aims to answer are:&#xD;
  &#xD;
          -  Whether the intervention is effective in reducing ischemic events&#xD;
  &#xD;
          -  Whether the intervention is effective in reducing inflammatory biomarkers' level&#xD;
  &#xD;
          -  Whether the intervention is safe for elderly patients&#xD;
  &#xD;
        Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no&#xD;
        specific intervention for one year. Patients enrolled should complete one-year follow-up in&#xD;
        the form of clinic visit or telephone call.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Open-label, Two-arm, Randomized, Superiority Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)</measure>
      <time_frame>From randomization to occurence of first event, assessed up to one year</time_frame>
      <description>Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular death</measure>
      <time_frame>From randomization to occurence of first event, assessed up to one year</time_frame>
      <description>Number of participants with cardiovascular death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spontaneous (nonprocedural) myocardial infarction</measure>
      <time_frame>From randomization to occurence of first event, assessed up to one year</time_frame>
      <description>Number of participants with spontaneous (nonprocedural) myocardial infarction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemia-driven coronary revascularization</measure>
      <time_frame>From randomization to occurence of first event, assessed up to one year</time_frame>
      <description>Number of participants with ischemia-driven coronary revascularization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemic stroke</measure>
      <time_frame>From randomization to occurence of first event, assessed up to one year</time_frame>
      <description>Number of participants having had a ischemic stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of hs-CRP</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Change of hs-CRP comparing to the baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of white blood cell count</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Change of white blood cell count comparing to the baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of neutrophil count</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Change of neutrophil count comparing to the baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of monocyte count</measure>
      <time_frame>From randomization to the end of treatment at one year</time_frame>
      <description>Change of monocyte count comparing to the baseline</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Nausea</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as nausea</description>
    </other_outcome>
    <other_outcome>
      <measure>Vomiting</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as vomiting</description>
    </other_outcome>
    <other_outcome>
      <measure>Diarrhea</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as diarrhea</description>
    </other_outcome>
    <other_outcome>
      <measure>Abdominal pain</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as abdominal pain</description>
    </other_outcome>
    <other_outcome>
      <measure>Muscle pain</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as muscle pain</description>
    </other_outcome>
    <other_outcome>
      <measure>Neuritis</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as neuritis</description>
    </other_outcome>
    <other_outcome>
      <measure>Rash</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as rash</description>
    </other_outcome>
    <other_outcome>
      <measure>Gout</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as gout</description>
    </other_outcome>
    <other_outcome>
      <measure>Hospitalization for infections</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as hospitalization for infections</description>
    </other_outcome>
    <other_outcome>
      <measure>New tumors</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Treatment-related adverse events as new tumors</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood pressure</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
      <description>Both systolic and diastolic blood pressure</description>
    </other_outcome>
    <other_outcome>
      <measure>Heart rate</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>White blood cell count</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Neutrophil count</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Monocyte count</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Hematocrit</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Hemoglobin level</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Platelet count</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Alanine aminotransferase</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Aspartate aminotransferase</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Gamma-glutamyltransferase</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Total bilirubin</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Direct bilirubin</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Serum albumin</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Total serum protein</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Serum creatinine</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Blood urea nitrogen</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Creatine Kinase</measure>
      <time_frame>From randomization to treatment at one month and one year</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Percutaneous Coronary Intervention</condition>
    <condition>Multivessel Coronary Artery Disease</condition>
    <condition>Elderly Patients</condition>
    <condition>C-Reactive Protein</condition>
    <arm_group>
      <arm_group_label>Colchicine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>colchicine</intervention_name>
      <description>Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.</description>
      <arm_group_label>Colchicine group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 60-80 years old&#xD;
  &#xD;
            -  Baseline plasma hs-CRP≥2 mg/L&#xD;
  &#xD;
            -  Hospitalized patients with coronary artery disease with multi-vessel lesions&#xD;
               (multi-vessel lesions are defined as at least 2 major epicardial coronary arteries&#xD;
               with ≥50% stenosis in their main branch diameter confirmed by coronary CT or coronary&#xD;
               angiography, with or without left main artery disease)&#xD;
  &#xD;
            -  Patients with myocardial ischemia-related symptoms or objective evidence are&#xD;
               successfully treated with PCI, and the condition is relatively stable&#xD;
  &#xD;
            -  Received standard drug therapies based on their condition at baseline (including&#xD;
               antiplatelet, lipid-lowering, blood pressure control, blood glucose control, and other&#xD;
               treatments recommended by guidelines)&#xD;
  &#xD;
            -  Subjects or legal representatives have signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have acute myocardial infarction within 30 days&#xD;
  &#xD;
            -  Patients who have taken colchicine and have a clear history of allergy or intolerance&#xD;
  &#xD;
            -  Patients with renal insufficiency, eGFR &lt;30 ml/min/1.73 m^2 (calculated by MDRD&#xD;
               formula) or blood creatinine levels exceeding 2 times the upper normal limit&#xD;
  &#xD;
            -  Patients with cirrhosis, chronic active hepatitis, liver function impairment (alanine&#xD;
               aminotransferase exceeding 3 times the upper normal limit or total bilirubin exceeding&#xD;
               2 times the upper normal limit) or cholestasis&#xD;
  &#xD;
            -  Patients with a known history of hypomyelodysplasia&#xD;
  &#xD;
            -  Patients with heart failure (NYHA Class III-IV) or severe valvular disease&#xD;
  &#xD;
            -  Patients with concomitant neoplastic or cancer disease&#xD;
  &#xD;
            -  Patients with chronic obstructive pulmonary disease or other chronic pulmonary disease&#xD;
  &#xD;
            -  Patients with poorly controlled disease, such as current cardiogenic shock,&#xD;
               hemodynamic instability, heart failure (NYHA Class III-IV), left ventricular ejection&#xD;
               fraction less than 35%, recent stroke (within the past 3 months), or any other&#xD;
               condition in which the investigator believes that participation in this study puts the&#xD;
               patient at risk&#xD;
  &#xD;
            -  Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or&#xD;
               chronic diarrhea&#xD;
  &#xD;
            -  Patients with hemoglobin less than 115 g/L, white blood cell count less than&#xD;
               4.0*10^9/L, or platelet count less than 110*10^9/L&#xD;
  &#xD;
            -  Patients are currently using or plan to begin chronic systemic steroid therapy (oral&#xD;
               or intravenous) during the study period (topical or inhaled steroids are allowed)&#xD;
  &#xD;
            -  Patients with acute inflammation or viral infection&#xD;
  &#xD;
            -  Female patients who are currently pregnant, planning to become pregnant, or&#xD;
               breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xueyan Zhao, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS &amp; PUMC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xueyan Zhao, M.D.</last_name>
      <phone>86-10-88322051</phone>
      <email>zhao_xueyan@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS &amp; PUMC</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xueyan Zhao, M.D.</last_name>
        <phone>86-10-88322051</phone>
        <email>zhao_xueyan@sina.com</email>
      </contact>
      <investigator>
        <last_name>Xueyan Zhao, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 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>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
      <investigator_full_name>Xueyan Zhao</investigator_full_name>
      <investigator_title>Chief physician, M.D., FACC, FESC, Doctoral supervisor</investigator_title>
    </responsible_party>
    <keyword>multivessel coronary artery disease</keyword>
    <keyword>percutaneous coronary intervention</keyword>
    <keyword>elderly patients</keyword>
    <keyword>colchicine</keyword>
    <keyword>high sensitive-C reactive protein</keyword>
    <keyword>efficacy and safety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</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>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/NCT06025071
  org study id: 2023-GSP-GG-40
  nct id: NCT06025071
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no
        specific intervention in selected elderly patients (60-80 years old) with residual
        inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions
        it aims to answer are:
  
          -  Whether the intervention is effective in reducing ischemic events
  
          -  Whether the intervention is effective in reducing inflammatory biomarkers' level
  
          -  Whether the intervention is safe for elderly patients
  
        Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no
        specific intervention for one year. Patients enrolled should complete one-year follow-up in
        the form of clinic visit or telephone call.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Open-label, Two-arm, Randomized, Superiority Trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
  measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
  time frame: From randomization to occurence of first event, assessed up to one year
  description: Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke
  measure: Cardiovascular death
  time frame: From randomization to occurence of first event, assessed up to one year
  description: Number of participants with cardiovascular death.
  measure: Spontaneous (nonprocedural) myocardial infarction
  time frame: From randomization to occurence of first event, assessed up to one year
  description: Number of participants with spontaneous (nonprocedural) myocardial infarction.
  measure: Ischemia-driven coronary revascularization
  time frame: From randomization to occurence of first event, assessed up to one year
  description: Number of participants with ischemia-driven coronary revascularization.
  measure: Ischemic stroke
  time frame: From randomization to occurence of first event, assessed up to one year
  description: Number of participants having had a ischemic stroke.
  measure: Change of hs-CRP
  time frame: From randomization to treatment at one month and one year
  description: Change of hs-CRP comparing to the baseline
  measure: Change of white blood cell count
  time frame: From randomization to treatment at one month and one year
  description: Change of white blood cell count comparing to the baseline
  measure: Change of neutrophil count
  time frame: From randomization to treatment at one month and one year
  description: Change of neutrophil count comparing to the baseline
  measure: Change of monocyte count
  time frame: From randomization to the end of treatment at one year
  description: Change of monocyte count comparing to the baseline
  measure: Nausea
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as nausea
  measure: Vomiting
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as vomiting
  measure: Diarrhea
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as diarrhea
  measure: Abdominal pain
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as abdominal pain
  measure: Muscle pain
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as muscle pain
  measure: Neuritis
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as neuritis
  measure: Rash
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as rash
  measure: Gout
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as gout
  measure: Hospitalization for infections
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as hospitalization for infections
  measure: New tumors
  time frame: From randomization to treatment at one month and one year
  description: Treatment-related adverse events as new tumors
  measure: Blood pressure
  time frame: From randomization to treatment at one month and one year
  description: Both systolic and diastolic blood pressure
  measure: Heart rate
  time frame: From randomization to treatment at one month and one year
  measure: White blood cell count
  time frame: From randomization to treatment at one month and one year
  measure: Neutrophil count
  time frame: From randomization to treatment at one month and one year
  measure: Monocyte count
  time frame: From randomization to treatment at one month and one year
  measure: Hematocrit
  time frame: From randomization to treatment at one month and one year
  measure: Hemoglobin level
  time frame: From randomization to treatment at one month and one year
  measure: Platelet count
  time frame: From randomization to treatment at one month and one year
  measure: Alanine aminotransferase
  time frame: From randomization to treatment at one month and one year
  measure: Aspartate aminotransferase
  time frame: From randomization to treatment at one month and one year
  measure: Gamma-glutamyltransferase
  time frame: From randomization to treatment at one month and one year
  measure: Total bilirubin
  time frame: From randomization to treatment at one month and one year
  measure: Direct bilirubin
  time frame: From randomization to treatment at one month and one year
  measure: Serum albumin
  time frame: From randomization to treatment at one month and one year
  measure: Total serum protein
  time frame: From randomization to treatment at one month and one year
  measure: Serum creatinine
  time frame: From randomization to treatment at one month and one year
  measure: Blood urea nitrogen
  time frame: From randomization to treatment at one month and one year
  measure: Creatine Kinase
  time frame: From randomization to treatment at one month and one year
  arm group label: Colchicine group
  arm group type: Experimental
  description: Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
  arm group label: Control group
  arm group type: No Intervention
  description: No intervention
  intervention type: Drug
  intervention name: colchicine
  description: Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
  arm group label: Colchicine group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Xueyan Zhao, M.D.
  role: Principal Investigator
  affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
  last name: Xueyan Zhao, M.D.
  phone: 86-10-88322051
  email: zhao_xueyan@sina.com
  facility: 
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
  investigator full name: Xueyan Zhao
  investigator title: Chief physician, M.D., FACC, FESC, Doctoral supervisor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  mesh term: Colchicine
  sharing ipd: No