<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/NCT03037047</url>
  </required_header>
  <id_info>
    <org_study_id>GV-MD-CT201601</org_study_id>
    <nct_id>NCT03037047</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris</brief_title>
  <official_title>Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Green Valley Group of China</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Green Valley Group of China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This parallel, double blind, randomized, controlled, multi-center study will evaluate the&#xD;
      efficacy and safety of salvianolate injection in elderly patients with unstable angina&#xD;
      pectoris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This parallel, double blind, randomized, controlled, multi-center study will evaluate the&#xD;
      efficacy and safety of salvianolate injection in elderly patients with unstable angina&#xD;
      pectoris. Patients will treated with or without salvianolate injection on the basis of&#xD;
      conventional therapy for 14 days. The primary measures of effectiveness include the change&#xD;
      from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4&#xD;
      items), the variation of EKG (level of the S-T segment)., Additional measures of&#xD;
      effectiveness include the change from baseline to the end of the treatment in the Seattle&#xD;
      Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study.&#xD;
      Patients who complete the double-blind portion of the study will be followed up 28 days.&#xD;
      Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence&#xD;
      of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days,&#xD;
      14 days and 28 days of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 11, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>symptom of angina pectoris</measure>
    <time_frame>up to 14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seattle angina scale score</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D health scale</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thrombolysis in myocardial infarction risk score</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cardiovascular and cerebrovascular events</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Unstable Angina</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% Sodium Chloride Injection</intervention_name>
    <description>Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>salvianolate injection</intervention_name>
    <description>Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Salvianolate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria&#xD;
&#xD;
          1. Patient in line with 1979 WHO diagnostic criteria for UA&#xD;
&#xD;
          2. Ages eligible for study: 60-85years (adult,senior)&#xD;
&#xD;
          3. Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take&#xD;
             CHD drugs standardly&#xD;
&#xD;
          4. Participates give written informed consent&#xD;
&#xD;
        exclusion criteria&#xD;
&#xD;
          1. NSTE-ACS caused by non atherosclerotic disease&#xD;
&#xD;
          2. Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic&#xD;
             state, mental stress, lack of sleep, eating too full, left ventricular load increased&#xD;
             (hypertension, aortic stenosis)&#xD;
&#xD;
          3. Angina pectoris caused byanemia, methemoglobinemia and hypoxemia&#xD;
&#xD;
          4. Abnormal thyroid function&#xD;
&#xD;
          5. Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure&#xD;
             ≥100mmHg)&#xD;
&#xD;
          6. Severe cardiopulmonary dysfunction&#xD;
&#xD;
          7. Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular&#xD;
             tachycardia, sinus bradycardia (heart rate &lt; 55),complete left bundle branch block&#xD;
&#xD;
          8. Combined liver and kidney and hematopoietic system and other serious diseases, liver&#xD;
             function (ALT, AST) 3 times higher than the upper limit of normal renal function,&#xD;
             creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2&#xD;
&#xD;
          9. Recent 4 weeks underwent surgery and bleeding tendency&#xD;
&#xD;
         10. Poor compliance&#xD;
&#xD;
         11. At the same time in other clinical researches&#xD;
&#xD;
         12. Allergic constitution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoying Li, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hongying Liu, doctor</last_name>
    <email>xiaowanzi010@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospita</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongying Liu, doctor</last_name>
      <phone>+86 10 68182255</phone>
      <email>xiaowanzi010@163.com</email>
    </contact>
    <investigator>
      <last_name>Xiaoying Li, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037047
org study id: GV-MD-CT201601
nct id: NCT03037047
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This parallel, double blind, randomized, controlled, multi-center study will evaluate the
      efficacy and safety of salvianolate injection in elderly patients with unstable angina
      pectoris.
This parallel, double blind, randomized, controlled, multi-center study will evaluate the
      efficacy and safety of salvianolate injection in elderly patients with unstable angina
      pectoris. Patients will treated with or without salvianolate injection on the basis of
      conventional therapy for 14 days. The primary measures of effectiveness include the change
      from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4
      items), the variation of EKG (level of the S-T segment)., Additional measures of
      effectiveness include the change from baseline to the end of the treatment in the Seattle
      Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study.
      Patients who complete the double-blind portion of the study will be followed up 28 days.
      Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence
      of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days,
      14 days and 28 days of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: symptom of angina pectoris
time frame: up to 14 days
measure: Seattle angina scale score
time frame: up to 28 days
measure: EQ-5D health scale
time frame: up to 28 days
measure: thrombolysis in myocardial infarction risk score
time frame: up to 28 days
measure: Incidence of cardiovascular and cerebrovascular events
time frame: up to 28 days
arm group label: Control group
arm group type: Placebo Comparator
description: patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.
arm group label: Experimental group
arm group type: Experimental
description: patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.
intervention type: Drug
intervention name: 0.9% Sodium Chloride Injection
description: Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
arm group label: Control group
other name: Normal saline
intervention type: Drug
intervention name: salvianolate injection
description: Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
arm group label: Experimental group
other name: Salvianolate
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Xiaoying Li, doctor
role: Study Chair
affiliation: Chinese PLA General Hospital
last name: Hongying Liu, doctor
email: xiaowanzi010@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Angina Pectoris
mesh term: Angina, Unstable
sharing ipd: Undecided