<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/NCT02254252</url>
  </required_header>
  <id_info>
    <org_study_id>12604</org_study_id>
    <nct_id>NCT02254252</nct_id>
  </id_info>
  <brief_title>Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow</brief_title>
  <official_title>Nicorandil Versus Nitroglycerin for Symptomatic Relief of Angina in Patients With Slow Coronary Flow Phenomenon Visited in Imam Reza Hospital, Mashhad, Iran</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed&#xD;
      opacification of epicardial arteries in the absence of significant arterial narrowing and&#xD;
      blockade. Endothelial dysfunction at the level of microarteries have been proposed as the&#xD;
      main pathological mechanism in this regard. Available evidence suggest that standard&#xD;
      anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might&#xD;
      not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is&#xD;
      hypothesized that anti-angina medications which exert vasodilatory effects in large coronary&#xD;
      arteries as well as small dividing branches might be superior to nitroglycerin in&#xD;
      amelioration of angina symptoms. The present randomized clinical trial was thus designed and&#xD;
      conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina&#xD;
      medication with effects on both large and small coronary vessels) with nitroglycerin in a&#xD;
      group of patients with slow coronary flow presented with frequent angina episodes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Angina Episode Frequnecy</measure>
    <time_frame>1 month</time_frame>
    <description>One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Angina Episode Intensity</measure>
    <time_frame>1 month</time_frame>
    <description>One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris</measure>
    <time_frame>1 month</time_frame>
    <description>One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side-effects</measure>
    <time_frame>1 month</time_frame>
    <description>Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Slow Coronary Flow</condition>
  <condition>Normal, or Near Normal Coronary Angiography</condition>
  <condition>Stable Angina</condition>
  <arm_group>
    <arm_group_label>Nitroglycerin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicorandil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicorandil</intervention_name>
    <description>nicorandil (10mg tablets, two times a day)</description>
    <arm_group_label>Nicorandil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitroglycerin</intervention_name>
    <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
    <arm_group_label>Nitroglycerin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  on coronary angiographic studies, arterial narrowing did not exceed 50% in any of the&#xD;
             three main coronary arteries; (&#xD;
&#xD;
          -  a delayed opacification in at least one of the main coronary arteries was documented.&#xD;
             Delayed opacification was defines as corrected TIMI frame count &gt; 23 fps&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  comorbid cardiovascular condition other than mild coronary atherosclerosis and&#xD;
             coronary slow flow&#xD;
&#xD;
          -  refusal to participate&#xD;
&#xD;
          -  discontinuation of treatment&#xD;
&#xD;
          -  not returning for the follow up visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>October 3, 2014</results_first_submitted>
  <results_first_submitted_qc>March 28, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 31, 2015</results_first_posted>
  <last_update_submitted>March 28, 2015</last_update_submitted>
  <last_update_submitted_qc>March 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Pouya Nezafati</investigator_full_name>
    <investigator_title>Dr. Pouya Nezafati</investigator_title>
  </responsible_party>
  <keyword>Slow coronary flow phenomenon</keyword>
  <keyword>Angina pectoris</keyword>
  <keyword>chest pain</keyword>
  <keyword>nicroandil</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>Nicorandil</mesh_term>
    <mesh_term>Nitroglycerin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nitroglycerin</title>
          <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
        </group>
        <group group_id="P2">
          <title>Nicorandil</title>
          <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nicorandil: nicorandil (10mg tablets, two times a day)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nitroglycerin</title>
          <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
        </group>
        <group group_id="B2">
          <title>Nicorandil</title>
          <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nicorandil: nicorandil (10mg tablets, two times a day)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.7" spread="13.3"/>
                    <measurement group_id="B2" value="54.6" spread="11.1"/>
                    <measurement group_id="B3" value="54.4" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Angina Episode Frequnecy</title>
        <description>One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nitroglycerin</title>
            <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
          </group>
          <group group_id="O2">
            <title>Nicorandil</title>
            <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nicorandil: nicorandil (10mg tablets, two times a day)</description>
          </group>
        </group_list>
        <measure>
          <title>Angina Episode Frequnecy</title>
          <description>One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.</description>
          <units>episodes per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="0.15"/>
                    <measurement group_id="O2" value="1.68" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Angina Episode Intensity</title>
        <description>One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nitroglycerin</title>
            <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
          </group>
          <group group_id="O2">
            <title>Nicorandil</title>
            <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nicorandil: nicorandil (10mg tablets, two times a day)</description>
          </group>
        </group_list>
        <measure>
          <title>Angina Episode Intensity</title>
          <description>One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.89" spread="0.30"/>
                    <measurement group_id="O2" value="3.03" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris</title>
        <description>One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nitroglycerin</title>
            <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
          </group>
          <group group_id="O2">
            <title>Nicorandil</title>
            <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nicorandil: nicorandil (10mg tablets, two times a day)</description>
          </group>
        </group_list>
        <measure>
          <title>Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris</title>
          <description>One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CCS Class I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CCS Class II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CCS Class III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Side-effects</title>
        <description>Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications</description>
        <time_frame>1 month</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Nitroglycerin</title>
          <description>sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)</description>
        </group>
        <group group_id="E2">
          <title>Nicorandil</title>
          <description>nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)&#xD;
Nicorandil: nicorandil (10mg tablets, two times a day)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pouya Nezafati</name_or_title>
      <organization>Mashhad University of Medical Sciences</organization>
      <phone>00989151578421</phone>
      <email>nezafatip871@mums.ac.ir</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02254252
org study id: 12604
nct id: NCT02254252
lead sponsor: 
has dmc: No
Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed
      opacification of epicardial arteries in the absence of significant arterial narrowing and
      blockade. Endothelial dysfunction at the level of microarteries have been proposed as the
      main pathological mechanism in this regard. Available evidence suggest that standard
      anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might
      not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is
      hypothesized that anti-angina medications which exert vasodilatory effects in large coronary
      arteries as well as small dividing branches might be superior to nitroglycerin in
      amelioration of angina symptoms. The present randomized clinical trial was thus designed and
      conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina
      medication with effects on both large and small coronary vessels) with nitroglycerin in a
      group of patients with slow coronary flow presented with frequent angina episodes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Angina Episode Frequnecy
time frame: 1 month
description: One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.
measure: Angina Episode Intensity
time frame: 1 month
description: One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.
measure: Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
time frame: 1 month
description: One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).
measure: Side-effects
time frame: 1 month
description: Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications
arm group label: Nitroglycerin
arm group type: Active Comparator
description: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
arm group label: Nicorandil
arm group type: Active Comparator
description: nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
intervention type: Drug
intervention name: Nicorandil
description: nicorandil (10mg tablets, two times a day)
arm group label: Nicorandil
intervention type: Drug
intervention name: Nitroglycerin
description: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
arm group label: Nitroglycerin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Pouya Nezafati
investigator title: Dr. Pouya Nezafati
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Nicorandil
mesh term: Nitroglycerin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 