<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/NCT03809273</url>
  </required_header>
  <id_info>
    <org_study_id>GrowfulPower-001</org_study_id>
    <nct_id>NCT03809273</nct_id>
  </id_info>
  <brief_title>Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI</brief_title>
  <acronym>HEARTRIP</acronym>
  <official_title>Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenyang Northern Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenyang Northern Hospital</source>
  <oversight_info>
    <has_dmc>No</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 study compared the effect of Yangxinshi on exercise tolerance of patients with&#xD;
      percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of&#xD;
      participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the&#xD;
      other half will receive Trimetazidine and Yangxinshi mimic tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Primary Purpose of this study is to compare the effect of Yangxinshi on exercise&#xD;
      tolerance of patients with percutaneous coronary intervention (PCI) for the first time with&#xD;
      Trimetazidine, The target patients are the people who underwent PCI for the first time and&#xD;
      can be carried on Cardiopulmonary exercise test. The treatment period was 24 weeks. The&#xD;
      patients were randomly divided into two groups.： A: Yangxinshi pill 3 pills /tid and&#xD;
      Trimetazidine mimic tablets 20mg/tid B: Trimetazidine mimic tablets 20mg/tid and Yangxinshi&#xD;
      pill 3 pills /tid The patients were followed up for 0 weeks, 4 weeks, 12 weeks, 24 weeks and&#xD;
      28 weeks after entering the group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Change in METs assessed by the CPET</measure>
    <time_frame>24 weeks</time_frame>
    <description>MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of anaerobic threshold (AT) by CPET</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major cardiovascular events (MACE)</measure>
    <time_frame>4,12,24 and 28 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ-9 Depression Scale</measure>
    <time_frame>24 weeks</time_frame>
    <description>PHQ=Patient health questionaire, score range: 0-27</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Seattle Angina Questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of angina pectoris</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of METs&gt;7 patients</measure>
    <time_frame>24 weeks</time_frame>
    <description>MET=Metabolic Equivalent of Task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of VO2max by CPET</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of VO2/HR by CPET</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of VO2/W by CPET</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAD-7 Anxiety Screening Scale</measure>
    <time_frame>24 weeks</time_frame>
    <description>GAD=Generalized Anxiety Disorder, score range: 0~21</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">668</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Yangxinshi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Trimetazidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yangxinshi</intervention_name>
    <description>Yangxinshi pill 3 pills /tid</description>
    <arm_group_label>Yangxinshi</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimetazidine</intervention_name>
    <description>Trimetazidine 20mg/tid</description>
    <arm_group_label>Trimetazidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yangxinshi mimic</intervention_name>
    <description>Yangxinshi mimic tablets 3 pills /tid</description>
    <arm_group_label>Trimetazidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimetazidine mimic</intervention_name>
    <description>Trimetazidine mimic tablets 20mg/tid</description>
    <arm_group_label>Yangxinshi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18~ 75, gender is not limited；&#xD;
&#xD;
          -  The patient within two month after PCI operation for the first time；&#xD;
&#xD;
          -  The patient had 1-2 coronary artery lesions with complete revascularization：At least&#xD;
             one drug eluting stent was implanted，and residual coronary artery stenosis after PCI&#xD;
             &lt;30%；&#xD;
&#xD;
          -  Have not revascularization plan within 6 months；&#xD;
&#xD;
          -  After being evaluated by clinicians on aerobic exercise ability，patients can carry out&#xD;
             early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside&#xD;
             the hospital；&#xD;
&#xD;
          -  Coronary heart disease patients with Qi Deficiency and Blood Stasis Syndrome；&#xD;
&#xD;
          -  Participants voluntarily participated in and signed informed consent；&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients was diagnosed with AMI as the first diagnosis in the past month, and then&#xD;
             hospitalized for PCI operation；&#xD;
&#xD;
          -  Patients with absolute and relative contraindications in cardiopulmonary exercise&#xD;
             test；&#xD;
&#xD;
          -  Any drug allergy to Yangxinshi pill and trimetazidine；&#xD;
&#xD;
          -  Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent&#xD;
             medicine regularly in the past month；&#xD;
&#xD;
          -  Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs&#xD;
             (such as massive hemorrhage, severe hypotension, etc.)；&#xD;
&#xD;
          -  History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis,&#xD;
             cerebral embolism and stroke of unknown type) or lower extremity arterial disease in&#xD;
             the past 6 months&#xD;
&#xD;
          -  Active bleeding disease within 6 months；&#xD;
&#xD;
          -  Combined with severe liver and kidney dysfunction (creatinine clearance ≤ 30ml / min&#xD;
             or in the active stage of kidney disease, serum aminotransferase ≥ 3 × upper limit of&#xD;
             clinical reference), other lifethreatening serious primary or psychiatric diseases and&#xD;
             malignant tumors&#xD;
&#xD;
          -  Hemoglobin &lt;90 g/L；&#xD;
&#xD;
          -  Cardiac function (NYHA) grade IV or echocardiography LVEF &lt; 30%；&#xD;
&#xD;
          -  Venous blood pressure &lt;100/60 mmHg；&#xD;
&#xD;
          -  In past 6 months, have medical history of: pregnancy, prepare or suspected of&#xD;
             pregnancy, abortion, breastfeeding or after childbirth&#xD;
&#xD;
          -  The expected survival period is less than one year.；&#xD;
&#xD;
          -  Patients who are participating in other clinical studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of University of Science and Technology of China</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kun L Ma, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xian W Liu, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hong Chen, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ming Chen, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yan J Chen, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cangzhou Central Hospital</name>
      <address>
        <city>Cangzhou</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jun Zhang, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hebei General Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xia M Liu, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Changchun Traditional Medicine University Affiliated Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping X Meng, Professor</last_name>
      <phone>13180889430</phone>
      <email>xiopingmeng@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Peng Qu, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>General Hospital of Northern Theater Command</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Zhang, MD</last_name>
      <phone>0086-13352459427</phone>
      <email>zj2fish@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinan Central Hospital Affiliated to Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun X Cai, Professor</last_name>
      <phone>13370587576</phone>
      <email>tianchr@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tao h Yuan, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bing Y Shao, Professor</last_name>
      <phone>18661675618</phone>
      <email>syb2004@yeah.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gang Y LI, Professor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ping Y Jia, Professor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenyang Northern Hospital</investigator_affiliation>
    <investigator_full_name>Han Yaling</investigator_full_name>
    <investigator_title>Director, clinical professor</investigator_title>
  </responsible_party>
  <keyword>Cardiopulmonary Exercise Test</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trimetazidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03809273
org study id: GrowfulPower-001
nct id: NCT03809273
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compared the effect of Yangxinshi on exercise tolerance of patients with
      percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of
      participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the
      other half will receive Trimetazidine and Yangxinshi mimic tablets.
The Primary Purpose of this study is to compare the effect of Yangxinshi on exercise
      tolerance of patients with percutaneous coronary intervention (PCI) for the first time with
      Trimetazidine, The target patients are the people who underwent PCI for the first time and
      can be carried on Cardiopulmonary exercise test. The treatment period was 24 weeks. The
      patients were randomly divided into two groups.： A: Yangxinshi pill 3 pills /tid and
      Trimetazidine mimic tablets 20mg/tid B: Trimetazidine mimic tablets 20mg/tid and Yangxinshi
      pill 3 pills /tid The patients were followed up for 0 weeks, 4 weeks, 12 weeks, 24 weeks and
      28 weeks after entering the group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in METs assessed by the CPET
time frame: 24 weeks
description: MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
measure: Changes of anaerobic threshold (AT) by CPET
time frame: 24 weeks
measure: Incidence of major cardiovascular events (MACE)
time frame: 4,12,24 and 28 weeks
measure: PHQ-9 Depression Scale
time frame: 24 weeks
description: PHQ=Patient health questionaire, score range: 0-27
measure: Changes of Seattle Angina Questionnaire
time frame: 24 weeks
description: The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)
measure: Frequency of angina pectoris
time frame: 24 weeks
measure: The proportion of METs>7 patients
time frame: 24 weeks
description: MET=Metabolic Equivalent of Task
measure: Changes of VO2max by CPET
time frame: 24 weeks
measure: Changes of VO2/HR by CPET
time frame: 24 weeks
measure: Changes of VO2/W by CPET
time frame: 24 weeks
measure: GAD-7 Anxiety Screening Scale
time frame: 24 weeks
description: GAD=Generalized Anxiety Disorder, score range: 0~21
arm group label: Yangxinshi
arm group type: Experimental
arm group label: Trimetazidine
arm group type: Active Comparator
intervention type: Drug
intervention name: Yangxinshi
description: Yangxinshi pill 3 pills /tid
arm group label: Yangxinshi
intervention type: Drug
intervention name: Trimetazidine
description: Trimetazidine 20mg/tid
arm group label: Trimetazidine
intervention type: Drug
intervention name: Yangxinshi mimic
description: Yangxinshi mimic tablets 3 pills /tid
arm group label: Trimetazidine
intervention type: Drug
intervention name: Trimetazidine mimic
description: Trimetazidine mimic tablets 20mg/tid
arm group label: Yangxinshi
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shenyang Northern Hospital
investigator full name: Han Yaling
investigator title: Director, clinical professor
mesh term: Trimetazidine
sharing ipd: No