<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/NCT01715376</url>
  </required_header>
  <id_info>
    <org_study_id>201007001-3-1</org_study_id>
    <nct_id>NCT01715376</nct_id>
  </id_info>
  <brief_title>Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events</brief_title>
  <official_title>Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changchun University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changchun University of Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compared with standardized western medical drug therapy, this study is mainly about whether&#xD;
      the combination of standardized western medical drug therapy and Chinese medical continued&#xD;
      treatment, can further decrease the rate of cardiovascular events for stable angina patients&#xD;
      and change the condition of angina.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will pick 1100 patients who are according with the II、III stage in CHD western medical&#xD;
      diagnosis standard, treat them with combination of standardized western medical drug therapy&#xD;
      and Chinese medical continued treatment, or only with standardized western medical drug&#xD;
      therapy,the treat course will last 6 months. The patients will be separated in two groups:&#xD;
      Integrative treatment of Chinese medicine and western medicine group(integrative group) and&#xD;
      western medical group according to the exposure factors(whether the patients accept&#xD;
      differentiation of TCM ) during the follow-up period, observe the main indexes: Primary&#xD;
      Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization.&#xD;
      Secondary endpoint: the events needed hospitalization which are because of (acute coronary&#xD;
      syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina&#xD;
      symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain&#xD;
      degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary end point all cause death</measure>
    <time_frame>up to 12 months</time_frame>
    <description>all because of death, stroke, nonfatal myocardial infarction, revascularization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secondary endpoint hospitalization</measure>
    <time_frame>up to 12months</time_frame>
    <description>the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angina symptoms</measure>
    <time_frame>up to 12months</time_frame>
    <description>Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>electrocardiogram</measure>
    <time_frame>up to 12months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>safety indicators</measure>
    <time_frame>up to 12months</time_frame>
    <description>ALT ,AST,BUN,CR,blood routine examination,urine routine</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1042</enrollment>
  <condition>Angina Pectoris</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Disease</condition>
  <condition>Heart Disease</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Chest Pain</condition>
  <condition>Pain</condition>
  <condition>Signs and Symptoms</condition>
  <condition>Arteriosclerosis</condition>
  <arm_group>
    <arm_group_label>Integrative Chinese and western medicine</arm_group_label>
    <description>Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Western medicine</arm_group_label>
    <description>western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        treat with combination of standardized western medical drug therapy and Chinese medical&#xD;
        continued treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the patients who are according with the II、III stage in CHD western medical diagnosis&#xD;
             standard；&#xD;
&#xD;
          2. age between 18 and 75(including 18 and 75)；&#xD;
&#xD;
          3. Signed the informed consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have&#xD;
             sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever&#xD;
             arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular&#xD;
             tachycardia and so on）；&#xD;
&#xD;
          2. the patients who have myocardial infarction or vascular remodeling in last 3 months；&#xD;
&#xD;
          3. hepatic and kidney function obstacle（ALT、AST&gt;1.5 times of normal upper limit value）；&#xD;
&#xD;
          4. the patients who cannot control blood glucose properly（fasting blood glucose&gt;7.0mmol/L&#xD;
             and/ or random blood glucose&gt;11.0mmol/L）；&#xD;
&#xD;
          5. the patients who have stroke in late 6 months（lacunar cerebral infarction is not&#xD;
             included）；&#xD;
&#xD;
          6. any other sever diseases such as malignant tumor；&#xD;
&#xD;
          7. the patients who attending other clinical study in late 3 months；&#xD;
&#xD;
          8. pregnant or lactating women；&#xD;
&#xD;
          9. the patients who have allergic constitution or are allergic to many drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>deng yue</last_name>
    <role>Study Chair</role>
    <affiliation>dirctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jilin Province TCM Institute of Chinese Medicine</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changchun University of Chinese Medicine</investigator_affiliation>
    <investigator_full_name>yue deng</investigator_full_name>
    <investigator_title>Director of cardiology department</investigator_title>
  </responsible_party>
  <keyword>traditional chinese medicine</keyword>
  <keyword>complementary therapies</keyword>
  <keyword>traditional chinese medicine syndrome scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Chest Pain</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/NCT01715376
org study id: 201007001-3-1
nct id: NCT01715376
lead sponsor: 
has dmc: Yes
Compared with standardized western medical drug therapy, this study is mainly about whether
      the combination of standardized western medical drug therapy and Chinese medical continued
      treatment, can further decrease the rate of cardiovascular events for stable angina patients
      and change the condition of angina.
We will pick 1100 patients who are according with the II、III stage in CHD western medical
      diagnosis standard, treat them with combination of standardized western medical drug therapy
      and Chinese medical continued treatment, or only with standardized western medical drug
      therapy,the treat course will last 6 months. The patients will be separated in two groups:
      Integrative treatment of Chinese medicine and western medicine group(integrative group) and
      western medical group according to the exposure factors(whether the patients accept
      differentiation of TCM ) during the follow-up period, observe the main indexes: Primary
      Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization.
      Secondary endpoint: the events needed hospitalization which are because of (acute coronary
      syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina
      symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain
      degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.
observational model: Cohort
time perspective: Prospective
measure: Primary end point all cause death
time frame: up to 12 months
description: all because of death, stroke, nonfatal myocardial infarction, revascularization.
measure: Secondary endpoint hospitalization
time frame: up to 12months
description: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications
measure: Angina symptoms
time frame: up to 12months
description: Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.
measure: electrocardiogram
time frame: up to 12months
measure: safety indicators
time frame: up to 12months
description: ALT ,AST,BUN,CR,blood routine examination,urine routine
arm group label: Integrative Chinese and western medicine
description: Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study.
arm group label: Western medicine
description: western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: deng yue
role: Study Chair
affiliation: dirctor
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changchun University of Chinese Medicine
investigator full name: yue deng
investigator title: Director of cardiology department
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
mesh term: Heart Diseases
mesh term: Angina Pectoris
mesh term: Arteriosclerosis
mesh term: Chest Pain