<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/NCT03759067</url>
  </required_header>
  <id_info>
    <org_study_id>KUMC_MECCA</org_study_id>
    <nct_id>NCT03759067</nct_id>
  </id_info>
  <brief_title>Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients</brief_title>
  <acronym>MECCA</acronym>
  <official_title>Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University Anam Hospital</source>
  <oversight_info>
    <has_dmc>No</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 study included 511 patients who underwent PCI because of angina during 2010-2011 at three&#xD;
      Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at&#xD;
      2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus&#xD;
      either a 300-mg reload (RL) or only the maintenance dose (MD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Elevation of myocardial infarction markers after coronary stenting reflects periprocedural&#xD;
      myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an&#xD;
      increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel&#xD;
      pre-treatment methods for preventing PMI among patients undergoing conventional CAG for&#xD;
      stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional&#xD;
      Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized,&#xD;
      multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI&#xD;
      for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil&#xD;
      General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD&#xD;
      group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using&#xD;
      daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were&#xD;
      randomized to receive either an additional 300-mg reload (the RL group) or no additional&#xD;
      loading (the maintenance dose [MD] group). The 600-mg or 75-mg treatment regimens were&#xD;
      selected at the physician's discretion. The primary outcome was creatinine kinase myocardial&#xD;
      band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h,&#xD;
      and 24 h, while troponin-I levels were measured at 8 h after the PCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2010</start_date>
  <completion_date type="Actual">July 31, 2013</completion_date>
  <primary_completion_date type="Actual">January 31, 2012</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>8hour mean CK-MB</measure>
    <time_frame>8hour after PCI</time_frame>
    <description>mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24hour mean CK-MB</measure>
    <time_frame>24hour after PCI</time_frame>
    <description>mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>8hour mean troponin-I</measure>
    <time_frame>8hour after PCI</time_frame>
    <description>mean troponin-I is checked 8hour after PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of periprocedural myocardial infarction (PMI)</measure>
    <time_frame>8hour or 24hour after PCI</time_frame>
    <description>Patients were considered to have PMI when their CK-MB level was elevated to &gt;3 times the upper limit of normal, which was defined as 4.94 ng/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause death</measure>
    <time_frame>9 months after PCI</time_frame>
    <description>All death is evaluated using chart reviews and telephone calls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary revascularization</measure>
    <time_frame>9 months after PCI</time_frame>
    <description>Coronary revascularization is evaluated using chart reviews and telephone. calls.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Moderate to severe GUSTO bleeding</measure>
    <time_frame>within 1week after PCI</time_frame>
    <description>Moderate GUSTO bleeding is defined as bleeding that requires blood transfusion but does not result in hemodynamic compromise. severe GUSTO bleeding is defined as a intracranial hemorrhage or hemodynamic compromise requiring treatment.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">511</enrollment>
  <condition>Angina, Stable</condition>
  <arm_group>
    <arm_group_label>LD group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>clopidogrel 600 mg once loading, usually 2-24 h before the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomization, the routine therapy using daily clopidogrel 75mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RL group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clopidogrel 75mg</intervention_name>
    <description>clopidogrel once daily 75mg</description>
    <arm_group_label>MD group</arm_group_label>
    <arm_group_label>RL group</arm_group_label>
    <other_name>MD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel 300 mg</intervention_name>
    <description>clopidogrel 300mg reloading</description>
    <arm_group_label>RL group</arm_group_label>
    <other_name>RL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clopidogrel 600mg</intervention_name>
    <description>clopidogrel 600mg loading</description>
    <arm_group_label>LD group</arm_group_label>
    <other_name>LD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence&#xD;
             below&#xD;
&#xD;
               1. Treadmil test positive&#xD;
&#xD;
               2. ST-T change in resting ECG or 24-hour ECG&#xD;
&#xD;
               3. Regional wall motion abnormality in Echocardiography or cardiac MRI&#xD;
&#xD;
               4. Myocardial ischemia at MIBI scan&#xD;
&#xD;
               5. moderate to severe stenosis at coronary CT angiography&#xD;
&#xD;
               6. chest pain or dyspnea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AST or ALT &gt; 3 times upper normal limits&#xD;
&#xD;
          -  Serum creatinine &gt; 2.0 mg/dL&#xD;
&#xD;
          -  chronic malaborption status (disorder or operation)&#xD;
&#xD;
          -  planned surgery within 1 year&#xD;
&#xD;
          -  pregnancy or breast-feeding patients&#xD;
&#xD;
          -  life expectancy &lt; 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.</citation>
    <PMID>21670242</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Anam Hospital</investigator_affiliation>
    <investigator_full_name>Do-sun Lim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>clopidogrel loading</keyword>
  <keyword>maintenance dose</keyword>
  <keyword>periprocedural MI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clopidogrel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03759067
org study id: KUMC_MECCA
nct id: NCT03759067
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study included 511 patients who underwent PCI because of angina during 2010-2011 at three
      Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at
      2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus
      either a 300-mg reload (RL) or only the maintenance dose (MD).
Elevation of myocardial infarction markers after coronary stenting reflects periprocedural
      myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an
      increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel
      pre-treatment methods for preventing PMI among patients undergoing conventional CAG for
      stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional
      Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized,
      multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI
      for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil
      General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD
      group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using
      daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were
      randomized to receive either an additional 300-mg reload (the RL group) or no additional
      loading (the maintenance dose [MD] group). The 600-mg or 75-mg treatment regimens were
      selected at the physician's discretion. The primary outcome was creatinine kinase myocardial
      band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h,
      and 24 h, while troponin-I levels were measured at 8 h after the PCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 8hour mean CK-MB
time frame: 8hour after PCI
description: mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
measure: 24hour mean CK-MB
time frame: 24hour after PCI
description: mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
measure: 8hour mean troponin-I
time frame: 8hour after PCI
description: mean troponin-I is checked 8hour after PCI
measure: Prevalence of periprocedural myocardial infarction (PMI)
time frame: 8hour or 24hour after PCI
description: Patients were considered to have PMI when their CK-MB level was elevated to >3 times the upper limit of normal, which was defined as 4.94 ng/mL.
measure: All cause death
time frame: 9 months after PCI
description: All death is evaluated using chart reviews and telephone calls.
measure: Coronary revascularization
time frame: 9 months after PCI
description: Coronary revascularization is evaluated using chart reviews and telephone. calls.
measure: Moderate to severe GUSTO bleeding
time frame: within 1week after PCI
description: Moderate GUSTO bleeding is defined as bleeding that requires blood transfusion but does not result in hemodynamic compromise. severe GUSTO bleeding is defined as a intracranial hemorrhage or hemodynamic compromise requiring treatment.
arm group label: LD group
arm group type: Active Comparator
description: clopidogrel 600 mg once loading, usually 2-24 h before the procedure
arm group label: MD group
arm group type: Experimental
description: After randomization, the routine therapy using daily clopidogrel 75mg
arm group label: RL group
arm group type: Active Comparator
description: After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.
intervention type: Drug
intervention name: clopidogrel 75mg
description: clopidogrel once daily 75mg
arm group label: MD group
arm group label: RL group
other name: MD
intervention type: Drug
intervention name: Clopidogrel 300 mg
description: clopidogrel 300mg reloading
arm group label: RL group
other name: RL
intervention type: Drug
intervention name: clopidogrel 600mg
description: clopidogrel 600mg loading
arm group label: LD group
other name: LD
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PMID: 21670242
responsible party type: Principal Investigator
investigator affiliation: Korea University Anam Hospital
investigator full name: Do-sun Lim
investigator title: Professor
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Clopidogrel
sharing ipd: No