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出境医 / 临床实验 / Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI (HEARTRIP)

Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI (HEARTRIP)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Drug: Yangxinshi Drug: Trimetazidine Drug: Yangxinshi mimic Drug: Trimetazidine mimic Phase 4

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Yangxinshi Drug: Yangxinshi
Yangxinshi pill 3 pills /tid

Drug: Trimetazidine mimic
Trimetazidine mimic tablets 20mg/tid
Active Comparator: Trimetazidine Drug: Trimetazidine
Trimetazidine 20mg/tid

Drug: Yangxinshi mimic
Yangxinshi mimic tablets 3 pills /tid
Outcome Measures
Primary Outcome Measures :
  1. Change in METs assessed by the CPET [ Time Frame: 24 weeks ]
    MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test


Secondary Outcome Measures :
  1. Changes of anaerobic threshold (AT) by CPET [ Time Frame: 24 weeks ]
  2. Incidence of major cardiovascular events (MACE) [ Time Frame: 4,12,24 and 28 weeks ]
  3. PHQ-9 Depression Scale [ Time Frame: 24 weeks ]
    PHQ=Patient health questionaire, score range: 0-27

  4. Changes of Seattle Angina Questionnaire [ Time Frame: 24 weeks ]
    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)

  5. Frequency of angina pectoris [ Time Frame: 24 weeks ]
  6. The proportion of METs>7 patients [ Time Frame: 24 weeks ]
    MET=Metabolic Equivalent of Task

  7. Changes of VO2max by CPET [ Time Frame: 24 weeks ]
  8. Changes of VO2/HR by CPET [ Time Frame: 24 weeks ]
  9. Changes of VO2/W by CPET [ Time Frame: 24 weeks ]
  10. GAD-7 Anxiety Screening Scale [ Time Frame: 24 weeks ]
    GAD=Generalized Anxiety Disorder, score range: 0~21


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18~ 75, gender is not limited；
  • The patient within two month after PCI operation for the first time；
  • The patient had 1-2 coronary artery lesions with complete revascularization：At least one drug eluting stent was implanted，and residual coronary artery stenosis after PCI <30%；
  • Have not revascularization plan within 6 months；
  • After being evaluated by clinicians on aerobic exercise ability，patients can carry out early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside the hospital；
  • Coronary heart disease patients with Qi Deficiency and Blood Stasis Syndrome；
  • Participants voluntarily participated in and signed informed consent；

Exclusion Criteria:

  • Patients was diagnosed with AMI as the first diagnosis in the past month, and then hospitalized for PCI operation；
  • Patients with absolute and relative contraindications in cardiopulmonary exercise test；
  • Any drug allergy to Yangxinshi pill and trimetazidine；
  • Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent medicine regularly in the past month；
  • Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs (such as massive hemorrhage, severe hypotension, etc.)；
  • History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
  • Active bleeding disease within 6 months；
  • Combined with severe liver and kidney dysfunction (creatinine clearance ≤ 30ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 3 × upper limit of clinical reference), other lifethreatening serious primary or psychiatric diseases and malignant tumors
  • Hemoglobin <90 g/L；
  • Cardiac function (NYHA) grade IV or echocardiography LVEF < 30%；
  • Venous blood pressure <100/60 mmHg；
  • In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
  • The expected survival period is less than one year.；
  • Patients who are participating in other clinical studies.
Contacts and Locations

Locations
Layout table for location information
China, Anhui
The First Affiliated Hospital of University of Science and Technology of China Not yet recruiting
Hefei, Anhui, China
Contact: Kun L Ma, Professor         
China, Beijing
Beijing Anzhen Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Xian W Liu, Professor         
Peking University People's Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Hong Chen, Professor         
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China
Contact: Ming Chen, Professor         
China, Guangdong
Guangdong Provincial People's Hospital Not yet recruiting
Guangzhou, Guangdong, China
Contact: Yan J Chen, Professor         
China, Hebei
Cangzhou Central Hospital Not yet recruiting
Cangzhou, Hebei, China
Contact: Jun Zhang, Professor         
Hebei General Hospital Not yet recruiting
Shijiazhuang, Hebei, China
Contact: Xia M Liu, Professor         
China, Jilin
Changchun Traditional Medicine University Affiliated Hospital Recruiting
Changchun, Jilin, China
Contact: Ping X Meng, Professor    13180889430    xiopingmeng@126.com   
China, Liaoning
The Second Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China
Contact: Peng Qu, Professor         
General Hospital of Northern Theater Command Recruiting
Shenyang, Liaoning, China, 110016
Contact: Jian Zhang, MD    0086-13352459427    zj2fish@163.com   
China, Shandong
Jinan Central Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China
Contact: Jun X Cai, Professor    13370587576    tianchr@126.com   
Shandong Provincial Hospital Not yet recruiting
Jinan, Shandong, China
Contact: Tao h Yuan, Professor         
Qingdao Municipal Hospital Recruiting
Qingdao, Shandong, China
Contact: Bing Y Shao, Professor    18661675618    syb2004@yeah.net   
China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China
Contact: Gang Y LI, Professor         
China, Shanxi
First Hospital of Shanxi Medical University Not yet recruiting
Taiyuan, Shanxi, China
Contact: Ping Y Jia, Professor         
Sponsors and Collaborators
Shenyang Northern Hospital
Tracking Information
First Submitted Date  ICMJE January 3, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019) 		Change in METs assessed by the CPET [ Time Frame: 24 weeks ]
MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Changes of anaerobic threshold (AT) by CPET [ Time Frame: 24 weeks ]
  • Incidence of major cardiovascular events (MACE) [ Time Frame: 4,12,24 and 28 weeks ]
  • PHQ-9 Depression Scale [ Time Frame: 24 weeks ]
    PHQ=Patient health questionaire, score range: 0-27
  • Changes of Seattle Angina Questionnaire [ Time Frame: 24 weeks ]
    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)
  • Frequency of angina pectoris [ Time Frame: 24 weeks ]
  • The proportion of METs>7 patients [ Time Frame: 24 weeks ]
    MET=Metabolic Equivalent of Task
  • Changes of VO2max by CPET [ Time Frame: 24 weeks ]
  • Changes of VO2/HR by CPET [ Time Frame: 24 weeks ]
  • Changes of VO2/W by CPET [ Time Frame: 24 weeks ]
  • GAD-7 Anxiety Screening Scale [ Time Frame: 24 weeks ]
    GAD=Generalized Anxiety Disorder, score range: 0~21
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Changes of anaerobic threshold (AT) by CPET [ Time Frame: 24 weeks ]
  • Incidence of major cardiovascular events (MACE) [ Time Frame: 4,12,24 and 28 weeks ]
  • Total score and reduction margin of Hamilton Depression Scale [ Time Frame: 24 weeks ]
  • Changes of Seattle Angina Questionnaire [ Time Frame: 24 weeks ]
    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)
  • Frequency of angina pectoris [ Time Frame: 24 weeks ]
  • The proportion of METs>7 patients [ Time Frame: 24 weeks ]
    MET=Metabolic Equivalent of Task
  • Changes of VO2max by CPET [ Time Frame: 24 weeks ]
  • Changes of VO2/HR by CPET [ Time Frame: 24 weeks ]
  • Changes of VO2/W by CPET [ Time Frame: 24 weeks ]
  • Total score and reduction margin of Hamilton Anxiety Scale [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI
Official Title  ICMJE Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Percutaneous Coronary Intervention
Intervention  ICMJE
  • Drug: Yangxinshi
    Yangxinshi pill 3 pills /tid
  • Drug: Trimetazidine
    Trimetazidine 20mg/tid
  • Drug: Yangxinshi mimic
    Yangxinshi mimic tablets 3 pills /tid
  • Drug: Trimetazidine mimic
    Trimetazidine mimic tablets 20mg/tid
Study Arms  ICMJE
  • Experimental: Yangxinshi
    Interventions:
    • Drug: Yangxinshi
    • Drug: Trimetazidine mimic
  • Active Comparator: Trimetazidine
    Interventions:
    • Drug: Trimetazidine
    • Drug: Yangxinshi mimic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		668
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2019) 		440
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18~ 75, gender is not limited；
  • The patient within two month after PCI operation for the first time；
  • The patient had 1-2 coronary artery lesions with complete revascularization：At least one drug eluting stent was implanted，and residual coronary artery stenosis after PCI <30%；
  • Have not revascularization plan within 6 months；
  • After being evaluated by clinicians on aerobic exercise ability，patients can carry out early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside the hospital；
  • Coronary heart disease patients with Qi Deficiency and Blood Stasis Syndrome；
  • Participants voluntarily participated in and signed informed consent；

Exclusion Criteria:

  • Patients was diagnosed with AMI as the first diagnosis in the past month, and then hospitalized for PCI operation；
  • Patients with absolute and relative contraindications in cardiopulmonary exercise test；
  • Any drug allergy to Yangxinshi pill and trimetazidine；
  • Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent medicine regularly in the past month；
  • Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs (such as massive hemorrhage, severe hypotension, etc.)；
  • History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
  • Active bleeding disease within 6 months；
  • Combined with severe liver and kidney dysfunction (creatinine clearance ≤ 30ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 3 × upper limit of clinical reference), other lifethreatening serious primary or psychiatric diseases and malignant tumors
  • Hemoglobin <90 g/L；
  • Cardiac function (NYHA) grade IV or echocardiography LVEF < 30%；
  • Venous blood pressure <100/60 mmHg；
  • In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
  • The expected survival period is less than one year.；
  • Patients who are participating in other clinical studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809273
Other Study ID Numbers  ICMJE GrowfulPower-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Han Yaling, Shenyang Northern Hospital
Study Sponsor  ICMJE Shenyang Northern Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenyang Northern Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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