<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/NCT01681316</url>
  </required_header>
  <id_info>
    <org_study_id>DH20120703</org_study_id>
    <nct_id>NCT01681316</nct_id>
  </id_info>
  <brief_title>Danhong Injection in the Treatment of Chronic Stable Angina</brief_title>
  <official_title>A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Food and Drug Administration</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of Danhong Injection on the relief of&#xD;
      angina with the use of the Seattle Angina Questionnaire among patients with stable angina&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total score of symptoms questionnaire of TCM</measure>
    <time_frame>Day 0, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales （The physical limitation, angina stability, treatment satisfaction, and quality of life）</measure>
    <time_frame>Day 0, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency of anginal attack every week</measure>
    <time_frame>Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Cardiovascular Society (CCS) grading of angina pectoris</measure>
    <time_frame>Day 0, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of Short-acting Nitrates</measure>
    <time_frame>Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the electrocardiogram (EKG)</measure>
    <time_frame>Day 0, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate</measure>
    <time_frame>Day 0, Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of new-onset major vascular events in 90 days</measure>
    <time_frame>Day 90</time_frame>
    <description>Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality in 90 days</measure>
    <time_frame>Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of severe hemorrhages in 90 days</measure>
    <time_frame>Day 90</time_frame>
    <description>The definition of &quot;Severe hemorrhages&quot; is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of moderate hemorrhages in 90 days</measure>
    <time_frame>Day 90</time_frame>
    <description>The definition of &quot;moderate hemorrhages&quot; is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Documentation of adverse events (AEs) and serious AEs</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The profiles of micro-RNA in 60 patients selected from certain centers</measure>
    <time_frame>Day 0, Day 14, Day 90</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The profiles of mRNA in 60 patients selected from certain centers</measure>
    <time_frame>Day 0, Day 14, Day 90</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">920</enrollment>
  <condition>Chronic Stable Angina</condition>
  <arm_group>
    <arm_group_label>Danhong injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Danhong injection</intervention_name>
    <description>A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower</description>
    <arm_group_label>Danhong injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard medical care</intervention_name>
    <description>Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).</description>
    <arm_group_label>Danhong injection</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male inpatients.&#xD;
&#xD;
          -  Age: 18 - 70 years.&#xD;
&#xD;
          -  Patients with clinical diagnosis of chronic stable angina and must meet one of the&#xD;
             following conditions:1）Patients who have a history of myocardial infarction and ST-T&#xD;
             changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery&#xD;
             shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease&#xD;
             were determined by radionuclide angiocardiography.&#xD;
&#xD;
          -  Clinical diagnosis of &quot;Xueyu Zheng&quot; (Blood Stasis Syndrome) as the scores of Chinese&#xD;
             medicine symptoms scales of &quot;Xueyu Zheng&quot; in angina ≥ 15. The Chinese medicine&#xD;
             symptoms scales of &quot;Xueyu Zheng&quot; is defined as following (1)chest pain-10, (2)chest&#xD;
             distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5,&#xD;
             (6) unsmooth pulse-5.&#xD;
&#xD;
          -  Patients with moderate angina pectoris (The definition of &quot;moderate angina pectoris &quot;&#xD;
             is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina&#xD;
             pectoris,which be classified to II or III.&#xD;
&#xD;
          -  Patient is willing to participate voluntarily and to sign a written patient informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is&#xD;
             under menstrual period.&#xD;
&#xD;
          -  Woman who disagree with contraception during treatment period&#xD;
&#xD;
          -  Patients with severe complications that would make the condition more complicated&#xD;
             assessed by the investigator, including liver or renal dysfunction, severe&#xD;
             cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary&#xD;
             disease, a history of epilepsy or cerebral hemorrhage .&#xD;
&#xD;
          -  Patients who were angina-free during the run-in period without taking any drug.&#xD;
&#xD;
          -  Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading&#xD;
             of angina pectoris class IV within the preceding 3 months&#xD;
&#xD;
          -  Patients with chest pain caused by other disease (e.g., acute myocardial&#xD;
             infarction，severe neurosis，menopausal syndrome，hyperthyroidism).&#xD;
&#xD;
          -  Patients with history of drug-induced bleeding or history of bleeding caused by&#xD;
             warfarin.&#xD;
&#xD;
          -  Patients with history of hematopoietic system diseases.&#xD;
&#xD;
          -  Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.&#xD;
&#xD;
          -  Patients who is participating in other trials or has been participated in other trials&#xD;
             in recent 3 months.&#xD;
&#xD;
          -  Patients with history of allergy or suspected allergic to the drug.&#xD;
&#xD;
          -  Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.&#xD;
&#xD;
          -  Patients with mental disorder.&#xD;
&#xD;
          -  Patients who were unable to participate in the study as judged by investigator.&#xD;
&#xD;
          -  Patients who were family members or relatives of the research center staffs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhong Wang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yun-dai Chen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital(301 Hospital)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yong-yan Wang, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiao-xi Du, Professor</last_name>
    <role>Study Director</role>
    <affiliation>China Food and Drug Administration</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guang'anmen Hospital, China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuan Wu Hospital Affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongfang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100078</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital(301 Hospital)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing Traditional Chinese Medicine Hopital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third People's Hospital of Chongqing</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <zip>150009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <zip>150040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University of T.C.M.</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Zhengzhou</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Provincial Hospital of T.C.M.</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changsha Central Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Changsha</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital to Hunan University of Chinese Medicine</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Province People's Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital to Changchun University of Chinese Medicine</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Zhongshan Hospital of Dalian University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Municipal Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital to Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an City Hospital of T.C.M.</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Province Hosptial of T.C.M.</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710068</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Shanxi University of Chinese Medicine</name>
      <address>
        <city>Xianyang</city>
        <state>Shanxi</state>
        <zip>712000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chengdu Sencond People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300150</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xin Hua Hospital of Zhejiang Province</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>October 11, 2016</last_update_submitted>
  <last_update_submitted_qc>October 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zhong Wang</investigator_full_name>
    <investigator_title>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>Chronic Stable Angina</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Traditional Chinese Medicine</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>
  <!-- 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/NCT01681316
org study id: DH20120703
nct id: NCT01681316
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the effect of Danhong Injection on the relief of
      angina with the use of the Seattle Angina Questionnaire among patients with stable angina
      patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30
time frame: Day 30
description: Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.
measure: Total score of symptoms questionnaire of TCM
time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
description: The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.
measure: The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales （The physical limitation, angina stability, treatment satisfaction, and quality of life）
time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
description: We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.
measure: The frequency of anginal attack every week
time frame: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
description: The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).
measure: Canadian Cardiovascular Society (CCS) grading of angina pectoris
time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Consumption of Short-acting Nitrates
time frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Change in the electrocardiogram (EKG)
time frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90
measure: Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate
time frame: Day 0, Day 14
measure: Incidence of new-onset major vascular events in 90 days
time frame: Day 90
description: Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.
measure: Overall mortality in 90 days
time frame: Day 90
measure: Incidence of severe hemorrhages in 90 days
time frame: Day 90
description: The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.
measure: Incidence of moderate hemorrhages in 90 days
time frame: Day 90
description: The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.
measure: Documentation of adverse events (AEs) and serious AEs
time frame: 90 days
measure: The profiles of micro-RNA in 60 patients selected from certain centers
time frame: Day 0, Day 14, Day 90
measure: The profiles of mRNA in 60 patients selected from certain centers
time frame: Day 0, Day 14, Day 90
arm group label: Danhong injection
arm group type: Experimental
description: Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
arm group label: Placebo
arm group type: Placebo Comparator
description: Based on the standard medical care, placebo was 40ml of 0.9% saline, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
intervention type: Drug
intervention name: Danhong injection
description: A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
arm group label: Danhong injection
intervention type: Other
intervention name: Standard medical care
description: Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
arm group label: Danhong injection
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
description: 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhong Wang, Professor
role: Principal Investigator
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
last name: Yun-dai Chen, Professor
role: Principal Investigator
affiliation: Chinese PLA General Hospital(301 Hospital)
last name: Yong-yan Wang, Professor
role: Study Chair
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
last name: Xiao-xi Du, Professor
role: Study Director
affiliation: China Food and Drug Administration
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country: China
responsible party type: Principal Investigator
investigator affiliation: China Academy of Chinese Medical Sciences
investigator full name: Zhong Wang
investigator title: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
mesh term: Angina Pectoris
mesh term: Angina, Stable