<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/NCT03010423</url>
  </required_header>
  <id_info>
    <org_study_id>EMR200505_506</org_study_id>
    <nct_id>NCT03010423</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants</brief_title>
  <acronym>SPET</acronym>
  <official_title>An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck KGaA, Darmstadt, Germany</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Serono Co., Ltd., China</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck KGaA, Darmstadt, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a single-center, interventional, pilot study to evaluate the improvement of&#xD;
      microvascular function by positron emission tomography (PET) after twelve-week treatment of&#xD;
      oral nicorandil in female non-obstructive CAD Participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated early, due to the lack of approval of data exportation from the Office&#xD;
    of Human Genetic Resource Administration (OHGRA) China.&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2016</start_date>
  <completion_date type="Actual">July 9, 2019</completion_date>
  <primary_completion_date type="Actual">July 9, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ejection Fraction at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Echocardiography was used to measure ejection fraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Echocardiography was used to measure LVESD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Left Ventricular Wall Thickness at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Echocardiography was used to measure left ventricular wall thickness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Echocardiography was used to measure E/A ratio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Seattle angina questionnaire (SAQ) score will be classified into five dimensions: physical limitation (question 1), anginal stability (question 2), anginal frequency (question 3-4), treatment satisfaction (question 5-8) and disease perception (question 9-11). Individual dimensions of the SAQ are transformed into the standard score between 0 and 100. The range of scores was 0 to 100, with higher scores indicates better functioning.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Non-obstructive Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Nicorandil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicorandil</intervention_name>
    <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
    <arm_group_label>Nicorandil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Participants aged 18-70 years&#xD;
&#xD;
          -  Participants with typical stable angina but without coronary obstruction (defined as&#xD;
             coronary occlusion less than (&lt;) 50%) by invasive coronary angiography or coronary&#xD;
             computed tomography angiography (CTA) in recent three months&#xD;
&#xD;
          -  All other long acting cardiovascular disease medicines, including but not limited to&#xD;
             aspirin/clopidogrel, calcium channel blockers (CCB), Angiotensin-converting enzyme&#xD;
             inhibitors (ACEI)/Angiotensin II Receptor Blockers (ARB), beta-blockers, statins,&#xD;
             ivabradine, trimetazidine, et al, should be stable taken for at least two weeks before&#xD;
             screening period&#xD;
&#xD;
          -  For participants who met these four criteria above, MFR will be tested by stress PET.&#xD;
             Participants whose MFR &lt;3.0 could be included in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Severe or uncontrolled hypertension (resting Systolic blood pressure [SBP] &gt;=160&#xD;
             millimeter of mercury (mmHg), or resting Diastolic blood pressure [DBP] &gt;=100mmHg at&#xD;
             screening period)&#xD;
&#xD;
          -  Participants with shock (including cardiogenic shock), or hypovolemia&#xD;
&#xD;
          -  Severe hypotension (resting SBP&lt;90mmHg，or resting DBP&lt;60mmHg)&#xD;
&#xD;
          -  Significant valvular heart disease, congenital heart disease or cardiomyopathy&#xD;
&#xD;
          -  Congestive heart failure(New York Heart Association [NYHA] III-IV), echocardiographic&#xD;
             ejection fraction&lt;45%&#xD;
&#xD;
          -  Acute pulmonary edema;&#xD;
&#xD;
          -  Hepatic or renal dysfunction, defined as:&#xD;
&#xD;
               -  Serum Alanine Aminotransferase (ALT) &gt; triple of the normal value upper limit;&#xD;
&#xD;
               -  Serum Aspartate Aminotransferase (AST) &gt; triple of the normal value upper limit&#xD;
&#xD;
               -  Serum creatinine &gt; twice of the normal value upper limit&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Active peptic ulcer or active skin ulcer&#xD;
&#xD;
          -  Taking glyburide, phosphodiesterase type 5 (PDE-5) inhibitor, soluble guanylate&#xD;
             cyclase stimulator(s)&#xD;
&#xD;
          -  Known to be hypersensitivity to nicorandil, nitrates, niacin, or any of the excipient&#xD;
&#xD;
          -  With contraindication to complete stress PET test&#xD;
&#xD;
          -  No legal ability and legal ability is limited&#xD;
&#xD;
          -  Participants unlikely to cooperate in the study or with inability or unwillingness to&#xD;
             give informed consent&#xD;
&#xD;
          -  Child-bearing period women without effective contraceptive measures, pregnancy and&#xD;
             lactation&#xD;
&#xD;
          -  Participation in another clinical trial within the past 30 days&#xD;
&#xD;
          -  Other significant disease that in the Investigator's opinion would exclude the&#xD;
             participant from the trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Responsible</last_name>
    <role>Study Director</role>
    <affiliation>Merck Serono Co., Ltd., China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking union medical college hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR200505_506</url>
    <description>Trial Awareness and Transparency website</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>June 18, 2020</results_first_submitted>
  <results_first_submitted_qc>June 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2020</results_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-obstructive coronary artery disease</keyword>
  <keyword>Nicorandil</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>Nicorandil</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03010423/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03010423/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nicorandil</title>
          <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study termination</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nicorandil</title>
          <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, therefore the data could not be extracted and hence data reported here is as per the total range reflecting in the inclusion criteria.</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Between &gt;=18 and &lt;= 70 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12</title>
        <description>Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12</title>
          <description>Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12</title>
        <description>Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12</title>
          <description>Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12</title>
        <description>Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12</title>
          <description>Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ejection Fraction at Week 12</title>
        <description>Echocardiography was used to measure ejection fraction.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ejection Fraction at Week 12</title>
          <description>Echocardiography was used to measure ejection fraction.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12</title>
        <description>Echocardiography was used to measure LVESD.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12</title>
          <description>Echocardiography was used to measure LVESD.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Left Ventricular Wall Thickness at Week 12</title>
        <description>Echocardiography was used to measure left ventricular wall thickness.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Left Ventricular Wall Thickness at Week 12</title>
          <description>Echocardiography was used to measure left ventricular wall thickness.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12</title>
        <description>Echocardiography was used to measure E/A ratio.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12</title>
          <description>Echocardiography was used to measure E/A ratio.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12</title>
        <description>Seattle angina questionnaire (SAQ) score will be classified into five dimensions: physical limitation (question 1), anginal stability (question 2), anginal frequency (question 3-4), treatment satisfaction (question 5-8) and disease perception (question 9-11). Individual dimensions of the SAQ are transformed into the standard score between 0 and 100. The range of scores was 0 to 100, with higher scores indicates better functioning.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicorandil</title>
            <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12</title>
          <description>Seattle angina questionnaire (SAQ) score will be classified into five dimensions: physical limitation (question 1), anginal stability (question 2), anginal frequency (question 3-4), treatment satisfaction (question 5-8) and disease perception (question 9-11). Individual dimensions of the SAQ are transformed into the standard score between 0 and 100. The range of scores was 0 to 100, with higher scores indicates better functioning.</description>
          <population>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 15 months</time_frame>
      <desc>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Thus, data for adverse event was not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nicorandil</title>
          <description>Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="0"/>
              </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 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>
    <limitations_and_caveats>The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Communication Center</name_or_title>
      <organization>Merck KGaA, Darmstadt, Germany</organization>
      <phone>+49-6151-72-5200</phone>
      <email>service@emdgroup.com</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/NCT03010423
org study id: EMR200505_506
nct id: NCT03010423
lead sponsor: 
collaborator: 
has dmc: No
The study is a single-center, interventional, pilot study to evaluate the improvement of
      microvascular function by positron emission tomography (PET) after twelve-week treatment of
      oral nicorandil in female non-obstructive CAD Participants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
time frame: Baseline, Week 12
description: Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
measure: Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12
time frame: Baseline, Week 12
description: Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
measure: Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12
time frame: Baseline, Week 12
description: Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
measure: Change From Baseline in Ejection Fraction at Week 12
time frame: Baseline, Week 12
description: Echocardiography was used to measure ejection fraction.
measure: Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
time frame: Baseline, Week 12
description: Echocardiography was used to measure LVESD.
measure: Change From Baseline in Left Ventricular Wall Thickness at Week 12
time frame: Baseline, Week 12
description: Echocardiography was used to measure left ventricular wall thickness.
measure: Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12
time frame: Baseline, Week 12
description: Echocardiography was used to measure E/A ratio.
measure: Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12
time frame: Baseline, Week 12
description: Seattle angina questionnaire (SAQ) score will be classified into five dimensions: physical limitation (question 1), anginal stability (question 2), anginal frequency (question 3-4), treatment satisfaction (question 5-8) and disease perception (question 9-11). Individual dimensions of the SAQ are transformed into the standard score between 0 and 100. The range of scores was 0 to 100, with higher scores indicates better functioning.
arm group label: Nicorandil
arm group type: Experimental
intervention type: Drug
intervention name: Nicorandil
description: Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
arm group label: Nicorandil
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Medical Responsible
role: Study Director
affiliation: Merck Serono Co., Ltd., China
facility: 
country: China
country: Germany
url: https://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR200505_506
description: Trial Awareness and Transparency website
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Nicorandil
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
point of contact: 