<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/NCT01723345</url>
  </required_header>
  <id_info>
    <org_study_id>90-1-94-8048</org_study_id>
    <nct_id>NCT01723345</nct_id>
  </id_info>
  <brief_title>Does Omega-3 Polyunsaturated Fatty Acids (PUFAs) Pretreatment Improve Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI)?</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Percutaneous coronary intervention (PCI) has become the most common form of coronary&#xD;
      revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks&#xD;
      including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It&#xD;
      is estimated that approximately 25% of patients undergoing PCI have significant&#xD;
      postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations&#xD;
      and approximately 50% of patients have significant post-procedural troponin elevations.&#xD;
      Initially, it was felt these elevations were simple enzyme leaks with no long-term&#xD;
      implications.&#xD;
&#xD;
      Now, several studies have demonstrated that periprocedural infarction is associated with&#xD;
      short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment&#xD;
      with antiplatelets such as aspirin and clopidogrel play an important role in reducing&#xD;
      cardiovascular events (CV events) following PCI.&#xD;
&#xD;
      Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve&#xD;
      response to aspirin and clopidogrel in low-response patients.&#xD;
&#xD;
      This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement&#xD;
      [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on short-term&#xD;
      (within 30 days) and long-term (after one year) major adverse cardiac events (MACE) in&#xD;
      patients undergoing elective PCI. Eighty patients planed to do elective PCI will be&#xD;
      categorized into two groups. The first group will be received standard regimen for PCI&#xD;
      (aspirin, clopidogrel, and heparin) and the second group will be treated with standard&#xD;
      regimen in addition to 3 gram omega 3 (12 hours before PCI). The main end point of the trial&#xD;
      was short-term (within 30-days) and long-term (after one year) incidence of MACE (death,&#xD;
      myocardial infarction, or unplanned revascularization).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>short-term MACE</measure>
    <time_frame>30 days</time_frame>
    <description>difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>long-term MACE</measure>
    <time_frame>one year</time_frame>
    <description>difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Coronary Arteriosclerosis</condition>
  <arm_group>
    <arm_group_label>omega 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive omega 3 in addition to standard treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>just receive standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omega 3</intervention_name>
    <description>3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI</description>
    <arm_group_label>omega 3</arm_group_label>
    <other_name>fish oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  candidate of elective PCI&#xD;
&#xD;
          -  Treatment with aspirin at least 5 days before PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  high CKMB and troponin I level&#xD;
&#xD;
          -  cardiac bypass in recent 3 months&#xD;
&#xD;
          -  platelet count &lt; 70×10 9/L&#xD;
&#xD;
          -  sever chronic renal failure&#xD;
&#xD;
          -  active bleeding&#xD;
&#xD;
          -  treatment with glycoprotein IIb/IIIa inhibitors during PCI&#xD;
&#xD;
          -  treatment with bivalirudin during PCI&#xD;
&#xD;
          -  sensitivity to aspirin and clopidogrel&#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>farzaneh foroughinia, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>jamshid salamzadeh, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>farzaneh foroughinia, phD</last_name>
    <phone>00989177136095</phone>
    <email>farzanehforoughinia@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Moddaress Hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>farzaneh foroughinia, phD</last_name>
      <phone>oo989177136095</phone>
      <email>farzanehforoughinia@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>farzaneh foroughinia, phD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>jamshid salamzadeh, phD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>mohammad hasan namazi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>January 26, 2013</last_update_submitted>
  <last_update_submitted_qc>January 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>farzaneh foroughinia</investigator_full_name>
    <investigator_title>phD of clinical pharmacy</investigator_title>
  </responsible_party>
  <keyword>elective percutaneous coronary intervention</keyword>
  <keyword>omega 3 polyunsaturated fatty acids (PUFAs)</keyword>
  <keyword>short-term MACE</keyword>
  <keyword>long-term MACE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01723345
org study id: 90-1-94-8048
nct id: NCT01723345
lead sponsor: 
collaborator: 
Percutaneous coronary intervention (PCI) has become the most common form of coronary
      revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks
      including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It
      is estimated that approximately 25% of patients undergoing PCI have significant
      postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations
      and approximately 50% of patients have significant post-procedural troponin elevations.
      Initially, it was felt these elevations were simple enzyme leaks with no long-term
      implications.

      Now, several studies have demonstrated that periprocedural infarction is associated with
      short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment
      with antiplatelets such as aspirin and clopidogrel play an important role in reducing
      cardiovascular events (CV events) following PCI.

      Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve
      response to aspirin and clopidogrel in low-response patients.

      This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement
      [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on short-term
      (within 30 days) and long-term (after one year) major adverse cardiac events (MACE) in
      patients undergoing elective PCI. Eighty patients planed to do elective PCI will be
      categorized into two groups. The first group will be received standard regimen for PCI
      (aspirin, clopidogrel, and heparin) and the second group will be treated with standard
      regimen in addition to 3 gram omega 3 (12 hours before PCI). The main end point of the trial
      was short-term (within 30-days) and long-term (after one year) incidence of MACE (death,
      myocardial infarction, or unplanned revascularization).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: short-term MACE
time frame: 30 days
description: difference between study and control group in 30-days major adverse cardiac events in patients undergoing PCI.
measure: long-term MACE
time frame: one year
description: difference between study and control group in one-year major adverse cardiac events in patients undergoing PCI.
arm group label: omega 3
arm group type: Active Comparator
description: receive omega 3 in addition to standard treatment
arm group label: control
arm group type: No Intervention
description: just receive standard treatment
intervention type: Drug
intervention name: omega 3
description: 3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
arm group label: omega 3
other name: fish oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: farzaneh foroughinia, phD
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
last name: jamshid salamzadeh, phD
role: Principal Investigator
affiliation: Shahid Beheshti University of Medical Sciences
last name: farzaneh foroughinia, phD
phone: 00989177136095
email: farzanehforoughinia@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: farzaneh foroughinia
investigator title: phD of clinical pharmacy
mesh term: Arteriosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia